SEARCH · PubMed Health

Results for “COSMETICS”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 73 records · Page 4Linked to original sources

PubMedDate not supplied

Cosmetic outcome and incidence of infection with the MammoSite breast brachytherapy applicator.

We present our results regarding the cosmetic outcome achieved and the rate of infection using the MammoSite breast brachytherapy applicator to treat patients with partial breast irradiation. In addition, factors associated with cosmetic outcome and infection are analyzed. The study population consisted of 30 patients with early stage breast cancer treated using the MammoSite device from October 28, 2002, to February 13, 2004. Cosmetic outcome was analyzed for its association with the following parameters: volume of the balloon, balloon-to-skin distance, maximal skin point dose per fraction, V100 (percent of volume that received 100% of the prescription dose), V150 (percent of volume that received 150% of the prescription dose), and V200 (percent of volume that received 200% of the prescription dose). The occurrence of infection at the time of treatment and during follow-up was also recorded. At a median follow-up of 13 months (range 1-16 months), 53.3% of the patients (16/30) were reported to have an excellent cosmetic outcome and 40.0% (12/30) had a good cosmetic outcome. Excellent cosmetic outcome was associated with a greater mean balloon-to-skin distance compared to those who achieved a good cosmetic outcome (1.5 cm versus 1.2 cm) (p = 0.164). The mean V100, V150, and V200 of those in the excellent cosmetic outcome group were 92.1%, 34.5%, and 7.6% versus 93.0%, 34.7%, and 7.6% in the good cosmetic outcome group (p = 0.642, 0.926, and 0.853), The mean balloon volumes were 47.7 cm3 and 56.9 cm3, respectively (p = 0.063) in the excellent and good outcome groups. The mean maximal skin doses per fraction in the excellent and good outcome groups were 354.8 cGy and 422.3 cGy (p = 0.286), respectively. Infection occurred in 13.3% of the patients (4/30). An excellent or good cosmetic outcome was achieved in 93.3% of patients and infection occurred in 13.3% of patients treated with the MammoSite breast brachytherapy applicator. Excellent cosmetic outcome was associated with a greater balloon-to-skin distance, lower maximal skin dose per fraction, and smaller mean balloon volume; however, the results did not reach statistical significance.

Adult↗

PubMed2005

Cosmetovigilance survey: are cosmetics considered safe by consumers?

Cosmetics are largely diffused substances topically applied to wash, to perfume or to improve the look, nevertheless the number of reported adverse reactions is very low, probably because of underreporting. This could be due to self-diagnosis and self-medication that is common in the presence of not severe reactions. In fact adverse reactions to cosmetics are generally not serious and frequently related to skin alterations. The aim of our study was to assess, through a questionnaire supplied by community pharmacists to the customers, the prevalence and characteristic of adverse cosmetic events (ACEs) reported by interviewed and the consequent measures adopted. To this aim ten Naples' community pharmacies were involved and pharmacists agreed to submit a specific questionnaire to all the customers of the pharmacy for two weeks between 9:00 a.m.-01:00 p.m. and 04:00 p.m.-08:00 p.m. from 1 to 15 June. The subjects interviewed were 4373, of them 845 refused to fill the questionnaire. Females responding to the questionnaire were 2716 and males 812. The 98.5% of the respondents reported to use cosmetics. Cosmetic users who experienced at least one ACE were 848 and 18.2% of them reported more than one event. Total adverse cosmetic events reported were 1507. A significant higher prevalence of adverse cosmetic events in women was observed, since the 26.5% of female cosmetic users experienced an adverse cosmetic event, whereas the percent was 17.4 for males. Concerning the type of adverse event, the 95.9% was a cutaneous event, whereas systemic events accounted for 4.1%. Among cutaneous reactions burning and itching were the most prominent and accounted for 36.3 and 32.9%, respectively. The most frequently reported systemic event was headache (40.3%) followed by nausea (24.2%). Product change (45.7%) and product suspension (39.6%), were the main specific measures adopted in the presence of ACEs. The general practitioner or the pharmacist were consulted only in the 6.8 and 6.3% of the episodes, respectively. In the 56.5% of the episodes consultation was not requested, whereas in the 26% a specialist was consulted. In conclusions our results, although supply information about ACEs and the consequent measures adopted by consumers of a restricted geographical area suggest that, due to the large use of these products and the relative high incidence of reported ACEs, the problem of cosmetic related injuries and the need of a system able to report, collect and evaluate them, cannot be ignored.

Consumer Behavior↗

PubMed2005

Final report of the safety assessment of L-Ascorbic Acid, Calcium Ascorbate, Magnesium Ascorbate, Magnesium Ascorbyl Phosphate, Sodium Ascorbate, and Sodium Ascorbyl Phosphate as used in cosmetics.

L-Ascorbic Acid, Calcium Ascorbate, Magnesium Ascorbate, Magnesium Ascorbyl Phosphate, Sodium Ascorbate, and Sodium Ascorbyl Phosphate function in cosmetic formulations primarily as antioxidants. Ascorbic Acid is commonly called Vitamin C. Ascorbic Acid is used as an antioxidant and pH adjuster in a large variety of cosmetic formulations, over 3/4 of which were hair dyes and colors at concentrations between 0.3% and 0.6%. For other uses, the reported concentrations were either very low (<0.01%) or in the 5% to 10% range. Calcium Ascorbate and Magnesium Ascorbate are described as antioxidants and skin conditioning agents--miscellaneous for use in cosmetics, but are not currently used. Sodium Ascorbyl Phosphate functions as an antioxidant in cosmetic products and is used at concentrations ranging from 0.01% to 3%. Magnesium Ascorbyl Phosphate functions as an antioxidant in cosmetics and was reported being used at concentrations from 0.001% to 3%. Sodium Ascorbate also functions as an antioxidant in cosmetics at concentrations from 0.0003% to 0.3%. Related ingredients (Ascorbyl Palmitate, Ascorbyl Dipalmitate, Ascorbyl Stearate, Erythorbic Acid, and Sodium Erythorbate) have been previously reviewed by the Cosmetic Ingredient Review (CIR) Expert Panel and found "to be safe for use as cosmetic ingredients in the present practices of good use." Ascorbic Acid is a generally recognized as safe (GRAS) substance for use as a chemical preservative in foods and as a nutrient and/or dietary supplement. Calcium Ascorbate and Sodium Ascorbate are listed as GRAS substances for use as chemical preservatives. L-Ascorbic Acid is readily and reversibly oxidized to L-dehydroascorbic acid and both forms exist in equilibrium in the body. Permeation rates of Ascorbic Acid through whole and stripped mouse skin were 3.43 +/- 0.74 microg/cm(2)/h and 33.2 +/- 5.2 microg/cm(2)/h. Acute oral and parenteral studies in mice, rats, rabbits, guinea pigs, dogs, and cats demonstrated little toxicity. Ascorbic Acid and Sodium Ascorbate acted as a nitrosation inhibitor in several food and cosmetic product studies. No compound-related clinical signs or gross or microscopic pathological effects were observed in either mice, rats, or guinea pigs in short-term studies. Male guinea pigs fed a control basal diet and given up to 250 mg Ascorbic Acid orally for 20 weeks had similar hemoglobin, blood glucose, serum iron, liver iron, and liver glycogen levels compared to control values. Male and female F344/N rats and B6C3F(1) mice were fed diets containing up to 100,000 ppm Ascorbic Acid for 13 weeks with little toxicity. Chronic Ascorbic Acid feeding studies showed toxic effects at dosages above 25 mg/kg body weight (bw) in rats and guinea pigs. Groups of male and female rats given daily doses up to 2000 mg/kg bw Ascorbic Acid for 2 years had no macro- or microscopically detectable toxic lesions. Mice given Ascorbic Acid subcutaneous and intravenous daily doses (500 to 1000 mg/kg bw) for 7 days had no changes in appetite, weight gain, and general behavior; and histological examination of various organs showed no changes. Ascorbic Acid was a photoprotectant when applied to mice and pig skin before exposure to ultraviolet (UV) radiation. The inhibition of UV-induced suppression of contact hypersensitivity was also noted. Magnesium Ascorbyl Phosphate administration immediately after exposure in hairless mice significantly delayed skin tumor formation and hyperplasia induced by chronic exposure to UV radiation. Pregnant mice and rats were given daily oral doses of Ascorbic Acid up to 1000 mg/kg bw with no indications of adult-toxic, teratogenic, or fetotoxic effects. Ascorbic Acid and Sodium Ascorbate were not genotoxic in several bacterial and mammalian test systems, consistent with the antioxidant properties of these chemicals. In the presence of certain enzyme systems or metal ions, evidence of genotoxicity was seen. The National Toxicology Program (NTP) conducted a 2-year oral carcinogenesis bioassay of Ascorbic Acid (25,000 and 50,000 ppm) in F344/N rats and B6C3F(1) mice. Ascorbic Acid was not carcinogenic in either sex of both rats and mice. Inhibition of carcinogenesis and tumor growth related to Ascorbic Acid's antioxidant properties has been reported. Sodium Ascorbate has been shown to promote the development of urinary carcinomas in two-stage carcinogenesis studies. Dermal application of Ascorbic Acid to patients with radiation dermatitis and burn victims had no adverse effects. Ascorbic Acid was a photoprotectant in clinical human UV studies at doses well above the minimal erythema dose (MED). An opaque cream containing 5% Ascorbic Acid did not induce dermal sensitization in 103 human subjects. A product containing 10% Ascorbic Acid was nonirritant in a 4-day minicumulative patch assay on human skin and a facial treatment containing 10% Ascorbic Acid was not a contact sensitizer in a maximization assay on 26 humans. Because of the structural and functional similarities of these ingredients, the Panel believes that the data on one ingredient can be extrapolated to all of them. The Expert Panel attributed the finding that Ascorbic Acid was genotoxic in these few assay systems due to the presence of other chemicals, e.g., metals, or certain enzyme systems, which effectively convert Ascorbic Acid's antioxidant action to that of a pro-oxidant. When Ascorbic Acid acts as an antioxidant, the Panel concluded that Ascorbic Acid is not genotoxic. Supporting this view were the carcinogenicity studies conducted by the NTP, which demonstrated no evidence of carcinogenicity. Ascorbic Acid was found to effectively inhibit nitrosamine yield in several test systems. The Panel did review studies in which Sodium Ascorbate acted as a tumor promoter in animals. These results were considered to be related to the concentration of sodium ions and the pH of urine in the test animals. Similar effects were seen with sodium bicarbonate. Because of the concern that certain metal ions may combine with these ingredients to produce pro-oxidant activity, the Panel cautioned formulators to be certain that these ingredients are acting as antioxidants in cosmetic formulations. The Panel believed that the clinical experience in which Ascorbic Acid was used on damaged skin with no adverse effects and the repeat-insult patch test (RIPT) using 5% Ascorbic Acid with negative results supports the finding that this group of ingredients does not present a risk of skin sensitization. These data coupled with an absence of reports in the clinical literature of Ascorbic Acid sensitization strongly support the safety of these ingredients.

Administration, Oral↗

PubMed2005

Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases.

BACKGROUND: Botulinum toxin type A (BTA) (Botox) received Food and Drug Administration (FDA) approval for therapeutic treatment of strabismus and blepharospasm in 1989, cervical dystonia in 2000, and cosmetic treatment of glabellar wrinkles (Botox Cosmetic) in 2002. In 2002 alone there were approximately 1.1 to 1.6 million patients using cosmetic BTA. Our objective was to review adverse event (AE) reporting to the FDA after BTA administration. METHODS: We reviewed all (therapeutic and cosmetic use) serious (per FDA regulations) AEs reported to the FDA for the 13.5 years since licensure of the product (December 1989-May 2003) and nonserious AEs reported from December 2001 to November 2002. AEs are reported to the FDA through the MedWatch system. RESULTS: We reviewed 1437 AE reports; 406 followed therapeutic use of BTA (217 serious and 189 nonserious) and 1031 followed cosmetic use (36 serious and 995 nonserious). Reported AEs occurred predominantly in female patients, with a median age of 50 years. In the year December 2001 to November 2002, when both serious and nonserious reports were evaluated, the proportion of reports classified as serious was 33-fold higher for therapeutic than for cosmetic cases. The 217 serious AEs reported in therapeutic cases involved a wide spectrum of events and included all 28 reported deaths. Among cosmetic users, no deaths were reported and, of the 36 serious AEs, 30 were included as possible complications in the FDA-approved label. The remaining 6 serious AEs did not display a pattern suggesting a common causal relationship to BTA. Among the 995 cosmetic cases reported to have nonserious AEs, most commonly noted were lack of effect (623, 63%), injection site reaction (190, 19%), and ptosis (111, 11%). CONCLUSIONS: Serious AEs were more likely to be reported for therapeutic than for cosmetic use, which may be related to higher doses, complicated underlying diseases, or both. Among cosmetic cases, few serious AEs were reported, and these were predominantly events that were previously recognized in clinical trials of BTA for the labeled use. This study is limited primarily by the incomplete nature of AE reporting by clinicians. Numerous departures from FDA-approved recommendations for drug dose, dilution, handling, site of injection, and storage were noted in these AE reports.

Adult↗

PubMed2006

Psychosocial factors predicting the motivation to undergo cosmetic surgery.

BACKGROUND: The present study investigates psychological factors expected to predict the motivation to undergo cosmetic surgery. It is hypothesized that body image, self-esteem, teasing history, acceptance of cosmetic surgery in the individual's environment, and self-monitoring relate to motivation to have cosmetic surgery. METHODS: Questionnaire data were obtained from 907 participants who responded to a survey distributed to a representative sample of Norwegian women aged 22 to 55 years. A second sample of 195 female prospective cosmetic surgery patients was recruited from a plastic surgery clinic. Measures of the hypothesized predictor variables were obtained from both samples. Surgery motivation was operationalized in two different ways. First, the women in the first sample were asked to indicate whether they wished to undergo cosmetic surgery, such that women who wished to have surgery could be compared with those who did not. Second, prospective patients were compared with women from the first sample who indicated that they did not wish to have cosmetic surgery. RESULTS: Analyses revealed all predictor variables but self-esteem to be related to either the wish or the decision to undergo surgery, or to both. Social acceptance of cosmetic surgery and body image were the strongest predictors of cosmetic surgery motivation. CONCLUSIONS: The study gives new insights into psychological factors predicting cosmetic surgery motivation. Furthermore, the influence of social factors on cosmetic surgery motivation is emphasized, and it is suggested that these factors be included in future research designs.

Adult↗

PubMed2005

Safety of ingredients used in cosmetics.

The Cosmetic Ingredient Review (CIR) program was established in 1976 by the Cosmetics, Toiletry, and Fragrance Association, with the support of the Food and Drug Administration (FDA) and the Consumer Federation of America (CFA). CIR performs independent, expert reviews to determine if ingredients used in cosmetics are safe. CIR staff prepares summaries of available data and the CIR Expert Panel reviews the data in open, public meetings. If more data are needed, requests are made. Unpublished studies may be provided, but become public and available for review once summarized in CIR safety assessments. Tentative conclusions are supported with a rationale and public comment is sought. Taking any input into consideration, a final safety assessment monograph is issued. These monographs are submitted for publication in the peer-reviewed International Journal of Toxicology . To date, 1194 individual cosmetic ingredients have been addressed. Of these, 683 were found to be safe in cosmetics in the present practices of use and concentration. With qualifications, another 388 have been found safe for use in cosmetics; specific qualifications for each are given. Nine ingredients have been deemed unsafe for use in cosmetics and the safety issue has been described. The available data were found insufficient to support the safety of 114 ingredients; the needed data are listed. Hair dyes represent an important product category reviewed by CIR. In considering hair dyes, the CIR Expert Panel reviews experimental and clinical data specific to the particular chemical structure of each hair dye and reviews epidemiologic studies that address hair dye use that are less specific. Recently the CIR Expert Panel concluded that the available epidemiologic studies are insufficient to conclude there is a causal relationship between hair dye use and cancer and other end points. It is inevitable that new information will become available concerning ingredients for which safety assessments were completed in the early days of the program. To consider new data, the CIR Expert Panel has instituted a re-review program. Sodium lauryl sulfate (SLS), formaldehyde, and parabens are discussed as examples. Safety assessments currently underway are listed, along with high-priority ingredients from which new work will be chosen. Although supported by the cosmetics industry, the CIR program has remained independent in its decision making, based on its open, public process; the integrity of the expert panel members; the participation of the FDA and the CFA; and the cooperation of the cosmetics industry.

Beauty Culture↗

PubMedDate not supplied

A perspective on the safety of cosmetic products: a position paper of the American Council on Science and Health.

Over the years, some activist groups have targeted cosmetics as possible human health threats, claiming that cosmetic ingredients are not adequately tested for safety and may pose risks to consumers. The groups allege that industry practices related to safety testing are flawed, that there is little government oversight, and that cosmetics contain cancer-causing chemicals and other toxicants. A critical review of the scientific data related to these claims indicates the following: (1) Industry has the primary responsibility to ensure that all ingredients, preservatives, and coformulants used in products are safe for their intended uses. (2) The U.S. Food and Drug Administration (FDA) has regulatory oversight of the cosmetic industry. Its authority includes the banning or restriction of ingredients for safety reasons. (3) The Cosmetic Ingredient Review (CIR), an independent, scientific review board, critically evaluates chemical ingredients used in cosmetics and publishes the results of its findings in the peer-reviewed literature. (4) Health-related allegations about cosmetic ingredients are generally based on the results of high-dose laboratory testing in animals and have little relevance for humans. As true now as when Paracelsus said it in the 16th century, "It is the dose that makes the poison." (5) The health-related allegations involving specific chemicals (e.g., phthalates, parabens, and 1,3-butadiene) fail to consider important scientific studies and recent regulatory conclusions about these chemicals, which have found that they are not hazardous. (6) Animal and human physiology differ in crucial ways, further invalidating simplistic attempts to extrapolate rodent testing to human health risks. The cosmetic industry should be encouraged to publish more of its toxicity studies and safety evaluations, which would aid in dispelling the uncertainty that some consumers have about cosmetic safety.

Animals↗

PubMed2006

Microbiological study of cosmetic products during their use by consumers: health risk and efficacy of preservative systems.

AIM: To evaluate the microbial contamination of 91 cosmetics (23 o/w emulsions, 47 tensiolytes, 21 aqueous pastes) in three different states of use (intact, in-use, ending product) and the protection efficacy of the preservative systems most frequently used in the analysed cosmetic formulations. METHODS AND RESULTS: Total bacterial count, isolation and identification of pathogenic isolates were performed on the collected cosmetics. About 10.6% of tensiolytes (13.5% bath foam, 6.7% shampoo, 10% liquid soaps) were contaminated by Staphylococcus warneri, Staphylococcus epidermidis and Pseudomonas putida. The efficacy of the preservative systems of two cosmetic products, tested against standard micro-organisms (Staphylococcus aureus ATCC 4338 and Pseudomonas aeruginosa ATCC 9027) and two isolates from cosmetics in this study (S. epidermidis and P. putida), satisfied the Cosmetics, Toiletries, and Fragrance Association and Official Italian Pharmacopeia criteria, while only one tested cosmetic respected the Rapid Challenge Test criterion. CONCLUSIONS: Contaminated cosmetic products are relatively uncommon, but some products, unable to suppress the growth of several micro-organisms, represent a potential health hazard. SIGNIFICANCE AND IMPACT OF THE STUDY: The challenge test may be performed not only during the preparation of the preservative system in the intact cosmetics, but also be used to evaluate the protection efficacy during their use.

Bacteria↗

PubMedDate not supplied

A novel volumetric method for quantitation of titanium dioxide in cosmetics.

Nowadays there are many sun-protection cosmetics incorporating organic or inorganic UV filters as active ingredients. Chemically stable inorganic sunscreen agents, usually metal oxides, are widely employed in high-SPF (sun protection factor) products. Titanium dioxide is one of the most frequently used inorganic UV filters. It has been used as a pigment for a long period of cosmetic history. With the development of micronization techniques, it has become possible to incorporate titanium dioxide in sunscreen formulations without the previous whitening effect, and hence its use in cosmetics has become an important research topic. However, there are very few works related to quantitation of titanium dioxide in sunscreen products. In this research, we analyzed the amounts of titanium dioxide in sunscreen cosmetics by adapting redox titration, reduction of Ti(IV) to Ti(III), and reoxidation to Ti(IV). After calcification of other organic ingredients of cosmetics, titanium dioxide is dissolved by hot sulfuric acid. The dissolved Ti(IV) is reduced to Ti(III) by adding metallic aluminum. The reduced Ti(III) is titrated against a standard oxidizing agent, Fe(III) (ammonium iron(III) sulfate), with potassium thiocyanate as an indicator. In order to test the accuracy and applicability of the proposed method, we analyzed the amounts of titanium dioxide in four types of sunscreen cosmetics, namely cream, make-up base, foundation, and powder, after adding known amounts of titanium dioxide (1 approximately 25 w/w%). The percentages of titanium dioxide recovered in the four types of formulations were in the range between 96% and 105%. We also analyzed seven commercial cosmetic products labeled with titanium dioxide as an ingredient and compared the results with those obtained from ICP-AES (inductively coupled plasma-atomic emission spectrometry), one of the most powerful atomic analysis techniques. The results showed that the titrated amounts were well in accord with the analyzed amounts of titanium dioxide by ICP-AES. Although instrument-based analytical methods, namely ICP-MS (inductively coupled plasma-mass spectrometry) and ICP-AES, are best for the analysis of titanium, it is difficult for small cosmetic companies to install such instruments because of their high cost. It was found that the volumetric method presented here gives quantitatively accurate and reliable results with routine lab-ware and chemicals.

Cosmetics↗

PubMed1990

Breast compliance: a new method for evaluation of cosmetic outcome after conservative treatment of early breast cancer.

As a measure of cosmetic outcome, the compliance of normal and irradiated breasts has been quantified using a new method of Breast Compliance Evaluation (BCE). A total of 151 women were studied, of whom 100 were normal controls and 51 had previous breast irradiation as part of breast-conserving treatment. Compliance was taken as the difference between the anterior breast surface length from infra-mammary fold to the nipple when the patient was in erect and supine positions. Irradiated cases were rated as having satisfactory outcome (good or excellent cosmetic result) or unsatisfactory (fair or poor cosmetic result). Mean compliance of normal cases was 1.8 cm. In the irradiated women with satisfactory cosmetic results, mean compliance was 1.45 compared with only 0.77 cm in those with unsatisfactory outcome. The difference between the compliance of both breasts was 0.1 cm for the controls, 0.3 cm in the satisfactory group and 2 cm in the unsatisfactory group. A difference in compliance greater than 1 cm was usually associated with an unsatisfactory cosmetic outcome. Factors determining cosmetic outcome included volume of excised lump and breast size. The cosmetic result was not affected by tumour site, clinical or pathological tumour size, or the total number of axillary nodes excised. This simple, painless, and easily reproducible measurement may be a useful objective indicator of cosmetic result after conservative treatment of early breast cancer.

Adult↗

PubMed2005

[Breast reconstruction: late cosmetic results of implant reconstruction].

The long cosmetic outcome of breast implant reconstruction is unknown. The morbidity and cosmetic outcome of 360 patients who underwent immediate breast reconstruction with various types of implant has been prospectively analysed over a 10-year period. 334 patients who completed their reconstruction were suitable for evaluation of their cosmetic outcome. The early complication rate (<2 months) was 9.1%, with an explantation rate of 1.6%. The late complication rate (>2 months) was 23%, with a pathological capsular contracture rate of 11% at two years and 15% at five years, and an implant removal rate of 7%. The revisional surgery rate was 30.2%. The cosmetic results were prospectively assessed using an objective five point global scale. Every patient was scored at each visit once surgery was completed. The overall cosmetic outcome deteriorates in a linear fashion from an initial acceptable result in 86% of patients two years after completion of their reconstruction to only 54% at five years. This fall off in the cosmetic outcome was not associated with the type of implant used, the volume of the implant, the age of the patient or the type of mastectomy incision employed. Radiotherapy was not a significant factor as only 28 patients were irradiated. However, on Cox model analysis pathological capsular contracture was the only factor which significantly contributed to a poor cosmetic outcome(P<0.0001 (relative risk 6.3). In spite of a high revisional surgery rate, deterioration still occurred, suggesting that other unaccounted for variables were responsible. On photographic retrospective review of those patients without a capsular contracture who demonstrated a deterioration in their cosmetic scores, it became clear that a possible reason for their poor result was late asymmetry produced by the failure of both breasts to undergo symmetrical ptosis as the patients aged.

Adult↗

PubMed2003

Cosmetic rhinoplasty in body dysmorphic disorder.

Body dysmorphic disorder (BDD) occurs in about 5% of patients seeking cosmetic surgery. Such patients are often dissatisfied with surgery or their symptoms of BDD are the same or worse after surgery. We report on a study that was designed to determine the frequency of BDD in patients requesting cosmetic rhinoplasty in the UK and to compare them with BDD patients in a psychiatric clinic. In the first stage of the study, we used a screening questionnaire for BDD and found that 20.7% of patients requesting rhinoplasty had a possible diagnosis of BDD. However, we believe that we identified a group of patients with sub-clinical or very mild BDD who are satisfied by cosmetic rhinoplasty. In the second stage of the study, we compared (a) patients without BDD who had a good outcome after cosmetic rhinoplasty with (b) BDD patients seen in a psychiatric clinic (who crave cosmetic rhinoplasty but for a variety of reasons do not obtain it). We found that BDD patients seen in a psychiatric clinic who desire cosmetic rhinoplasty are a quite distinct population from those obtaining routine rhinoplasty without symptoms of BDD. BDD patients are significantly younger, more depressed and anxious than this group, and are more preoccupied by their nose and check their nose more frequently. They are more likely to conduct "D.I.Y" surgery and have multiple concerns about their body. They are more likely to be significantly handicapped in their occupation, social life, and in intimate relationships and to avoid social situations because of their nose. They are therefore more likely to believe that dramatic changes would occur in their life after a rhinoplasty. This study provides some clues for surgeons who wish to identify patients with BDD who might have a poor prognosis in cosmetic rhinoplasty. Further research is required in the development of a screening questionnaire or interview for identifying patients with BDD seeking cosmetic surgery.

Adult↗

PubMed1999

Validation of the methods of cosmetic assessment after breast-conserving therapy in the EORTC "boost versus no boost" trial. EORTC Radiotherapy and Breast Cancer Cooperative Groups. European Organization for Research and Treatment of Cancer.

PURPOSE: To evaluate both qualitative and quantitative scoring methods for the cosmetic result after breast-conserving therapy (BCT), and to compare the usefulness and reliability of these methods. METHODS AND MATERIALS: In EORTC trial 22881/10882, stage I and II breast cancer patients were treated with tumorectomy and axillary dissection. A total of 5318 patients were randomized between no boost and a boost of 16 Gy following whole-breast irradiation of 50 Gy. The cosmetic result was assessed for 731 patients in two ways. A panel scored the qualitative appearance of the breast using photographs taken after surgery and 3 years later. Digitizer measurements of the displacement of the nipple were also made using these photographs in order to calculate the breast retraction assessment (BRA). The cosmetic results after 3-year follow-up were used to analyze the correlation between the panel evaluation and digitizer measurements. RESULTS: For the panel evaluation the intraobserver agreement for the global cosmetic score as measured by the simple Kappa statistic was 0.42, considered moderate agreement. The multiple Kappa statistic for interobserver agreement for the global cosmetic score was 0.28, considered fair agreement. The specific cosmetic items scored by the panel were all significantly related to the global cosmetic score; breast size and shape influenced the global score most. For the digitizer measurements, the standard deviation from the average value of 30.0 mm was 2.3 mm (7.7%) for the intraobserver variability and 2.6 mm (8.7%) for the interobserver variability. The two methods were significantly, though moderately, correlated; some items scored by the panel were only correlated to the digitizer measurements if the tumor was not located in the inferior quadrant of the breast. CONCLUSIONS: The intra- and interobserver variability of the digitizer evaluation of cosmesis was smaller than that of the panel evaluation. However, there are some treatment sequelae, such as disturbing scars and skin changes, that can not be evaluated by BRA measurements. Therefore, the methods of cosmetic evaluation used in a study must be chosen in a way that balances reliability and comprehensiveness.

Adult↗

PubMed2001

Prospective evaluation of late cosmetic results following breast reconstruction: I. Implant reconstruction.

The long-term cosmetic outcome of breast implant reconstruction is unknown. The morbidity and cosmetic outcome of 360 patients who underwent immediate postmastectomy breast reconstruction with various types of implants have been analyzed prospectively over a 9-year period. Of these patients, 334 who completed their reconstruction were suitable for evaluation of their cosmetic outcome. The early complication rate (< 2 months) was 9.2 percent, with an explantation rate of 1.7 percent. The late complication rate (> 2 months) was 23 percent, with a pathological capsular contracture rate of 11 percent at 2 years and 15 percent at 5 years and an implant removal rate of 7 percent. The revisional surgery rate was 30.2 percent. The cosmetic results were assessed prospectively using an objective five-point global scale. Every patient was scored at each visit once surgery was completed. The overall cosmetic outcome deteriorated in a linear fashion, from an initial acceptable result of 86 percent 2 years after patients completed their reconstruction to only 54 percent at 5 years. This decline in cosmetic outcome was not associated with the type of implant used, the volume of the implant, the age of the patient, or the type of mastectomy incision employed. Radiotherapy was not a significant factor because only 28 patients were irradiated. Upon Cox model analysis, pathological capsular contracture was the only factor that contributed significantly to a poor cosmetic outcome in which p < 0.0001 (relative risk 6.3). Despite a high revisional surgery rate, deterioration still occurred, suggesting that other unaccounted for variables were responsible. On photographic retrospective review of the patients without capsular contracture who demonstrated deterioration in their cosmetic scores, it became clear that a possible reason for their poor results was late asymmetry produced by the failure of both breasts to undergo symmetrical ptosis with aging.

Adult↗

PubMed2002

Discount cosmetic surgery: industry trends and strategies for success.

Discount cosmetic surgery is a topic of interest to plastic surgeons. To understand this trend and its effects on plastic surgeons, it is necessary to review the economics of cosmetic surgery, plastic surgery's practice environment, and the broader business principles of service industries. Recent work looked at the economics of the plastic surgery market. This analysis demonstrated that increased local density of plastic surgeons was associated with lower adjusted fees for cosmetic procedures. A survey of plastic surgeons about their practice environment revealed that 93 percent categorized the majority of their patients as very or moderately price-sensitive. Fully 98 percent described their business climate as very or moderately competitive and most plastic surgeons thought they lost a sizable number of cosmetic patients within the last year for reasons of price.A standard industry analysis, when applied to cosmetic surgery, reveals the following: an increased number of surgeons leads to lower fees (reducing their bargaining power as suppliers), patients are price-sensitive (increasing their bargaining power as buyers), and there are few barriers to entry among providers (allowing potential new entrants into the market). Such a situation is conducive to discounting taking hold-and even becoming the industry norm. In this environment, business strategy dictates there are three protocols for success: discounting, differentiation, and focus. Discounting joins the trend toward cutting fees. Success comes from increasing volume and efficiency and thus preserving profits. Differentiation creates an industrywide perception of uniqueness; this requires broadly positioning plastic surgeons as holders of a distinct brand identity separate from other "cosmetic surgeons." The final strategy is to focus on a particular buyer group to develop a market niche, such as establishing a "Park Avenue" practice catering to patients who demand a prestigious surgeon, although this is likely a small segment of the overall patient population. Plastic surgeons that buck the trend toward discount cosmetic surgery must take concrete and potentially costly steps to implement a plausible strategy for distinguishing their practices within the crowded cosmetic surgery market.

Cost Control↗

PubMed1999

[Cosmetics: definition and legal aspects of the term].

Classification of cosmetics, which are more and more similar to topical therapeutic agents, is getting increasingly difficult for dermatologists. Their definition within the EU and the respective European directives, replacing national laws step by step, will be briefly presented. The problems of distinguishing cosmetics from medicinal products will be discussed in detail by examples from clinical practice. Finally, we will review the various active substances which tend to be added to cosmetics following the global trend in the cosmetic industry towards developing "medicinally" active cosmetics, and in the pharmaceutical industry towards "cosmetically" oriented medicinal products as part of a current "life-style" ideology. In some clinical dermatological fields these active substances may allow the dermatologists to use cosmetics as topical therapeutic agents.

Cosmetics↗

PubMed2004

Safety evaluation of cosmetics in the EU. Reality and challenges for the toxicologist.

Council Directive 76/768/EEC, its seven amendments and 30 adaptations to technical progress form the basis of the cosmetic EU legislation today. There are actually four key principles for safety in the cosmetic legislation. (i) The full responsibility for the safety of cosmetics for human health is placed on the manufacturer, first importer in the EU or marketer. (ii) The safety evaluation of finished products is based on safety of individual ingredients, more specifically on their chemical structure, toxicological profile and their level of exposure. (iii) A compilation of information on each cosmetic product (dossier) must be kept readily available for inspection by the competent authorities of the Member State concerned. This information source, usually called a technical information file (TIF) or product information file/requirements (PIF(R)), contains, as the most important part, the safety assessment of the product undersigned by a competent safety assessor. (iv) The use of validated replacement alternative methods instead of animal testing forms the 4th key principle for safety of cosmetic products on the EU market. The 7th amendment imposes strict deadlines for the abolition of animal in vivo studies on cosmetic ingredients. These legal requirements induce a number of important challenges for the cosmetic industry and more specifically for the toxicologist involved as safety assessor.

Animal Testing Alternatives↗

PubMed2001

Efficacy testing of cosmetic products. A proposal to the European Community by the Danish Environmental Protection Agency, Ministry of Environment and Energy.

BACKGROUND/AIMS: Regulations for cosmetic products primarily address safety of the products that may be used by large populations of healthy consumers. Requirements for documentation of efficacy claims are only fragmentary. This synopsis aims to review and conclude a set of standards that may be acceptable to the European Community, and the cosmetic industry, as a legal standard for efficacy documentation in Europe in the future. METHODS AND RESULTS: Ethical, formal, experimental, statistical and other aspects of efficacy testing are described, including validation, quality control and assurance. The importance of user relevant clinical end points, a controlled randomized trial design and evidence-based cosmetic product documentation, validation of methods, statistical power estimation and proper data handling, reporting and archiving is emphasized. The main principles of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) should be followed by the cosmetics industry in a spirit of good documentation standard and scientific soundness, but full GCP is not considered mandatory in the field of cosmetics. Documentation by validated bio-instrumental methods may be acceptable, but efficacy documentation based on information about raw materials, reference to literature and laboratory experiments are only acceptable in exceptional cases. CONCLUSIONS: Principles for efficacy substantiation of cosmetic products in Europe, as described in this synopsis, are officially proposed by the Danish Ministry of Environment and Energy to the European Community as a basis for an amendment to the Cosmetics Directive or otherwise implemented as a European Community regulation.

Clinical Trials as Topic↗