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Biomedical subjects

Leslie Baumann

Publications and source records attributed to Leslie Baumann.

17 recordsLinked to original sources

Collagen-containing fillers: alone and in combination.

Soft tissue fillers may be injected into facial skin to ameliorate the appearance of fine lines and wrinkles, to augment lips and hollow cheeks, and to correct other imperfections, ultimately producing a more youthful appearance. Animal- and human-derived collagen implants have been used successfully for soft tissue augmentation for several years. Bovine collagen fillers were the most popular injectable implants for nearly 2 decades in the United States. Although these are still used, human bioengineered collagen products and fillers that contain hyaluronic acid have become available and are now more commonly used than the bovine-derived products. This article discusses the rationale for using the various types of fillers in combination and describes techniques for combining these fillers.

Collagen↗

A quality rating scale for aesthetic surgical procedures.

BACKGROUND: Cosmetic dermatologic procedures offer the promise of visible aesthetic enhancement with minimal risk. While in recent years the number of available procedures has proliferated, there are few objective methods for evaluating the relative quality of these procedures for particular indications or specific patients. OBJECTIVE: (A) To develop a simple, easy-to-use numerical rating scale to assess the quality of cosmetic surgical procedures on a range of parameters pertaining to clinical efficacy and patient satisfaction; (B) to statistically validate the discriminative value of this rating scale. METHODS: (A) Patient and physician interviews were performed to elicit a list of factors that may collectively characterize the clinical efficacy and patient tolerability of cosmetic dermatologic procedures. A 0-100 point rating scale was developed based on these factors, with the face-validity of this scale checked by a group of patients and physicians; (B) Statistical analysis of the questionnaire was performed by asking 15 expert cosmetic dermatologic surgeons to use it to rate 23 common cosmetic dermatologic procedures, and analyzing the results. RESULTS: (A) An easy-to-use scale was constructed to assess the quality of cosmetic dermatologic procedures by rating the associated cost, risk, time (procedure and recovery), discomfort, results, and longevity of benefit. A "physician adjustment factor" was used to further increase the relevance of this 0-100 point scale for specific patients; (B) Repeated-measures analysis of variations (ANOVAs) performed on the data from the survey of experts demonstrated that this scale can be used to discriminate between common dermatologic procedures. The differences in mean subscores and total scores among procedures grouped by anatomic site and target lesion-type were significant at the level of P < .05. LIMITATIONS: Patient preferences exogenous to the rating scale may increase or decrease the suitability of specific procedures. CONCLUSIONS: Common cosmetic dermatologic procedures are of uniformly high quality, as per expert ratings on a systematic measure. This quality rating scale appears statistically valid and robust, given that expert raters assigned similar ratings to the same procedures but mean ratings were different across procedures. In the future, this quality rating scale can be used to assess novel interventions, and to help dermatologic surgeons faced with patient concern to optimally select among alternative procedures for a given indication.

Botulinum Toxins, Type A↗

A dermatologist's opinion on hormone therapy and skin aging.

The Taylor et al. study in this issue suggests that long-term hormone replacement therapy helps prevent skin aging. All patients interested in preventing skin aging should regularly use sunscreens, retinoids, and oral or topical antioxidants.

Dermatologic Agents↗

Pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for treatment of axillary hyperhidrosis.

BACKGROUND: Botulinum toxin type B (BTX-B, Myobloc, San Francisco, CA, USA) was FDA-approved for the treatment of cervical dystonia in December 2000. It has since been used off-label for the treatment of axillary hyperhidrosis. However, there are sparse data in the medical literature evaluating the safety and efficacy of Myobloc (botulinum toxin type B) for this indication. OBJECTIVE: To assess the safety, efficacy and duration of action of Myobloc (botulinum toxin type B) in the treatment of bilateral axillary hyperhidrosis. METHODS: This study was a double-blinded, randomized, pilot study conducted in an outpatient office setting at a private academic medical center beginning in November 2001. Twenty-three male and female volunteers between the ages of 18 and 80 were screened for participation; 20 participants with primary axillary hyperhidrosis were enrolled. Participants were injected subcutaneously with either Myobloc (botulinum toxin type B) (2500 U, or 0.5 ml, per axilla) or 0.5 ml vehicle (100 mM NaCl, 10 mM succinate, and 0.5 mg/ml human albumin) into bilateral axillae. Participants who received placebo were rolled over and received Myobloc (botulinum toxin type B) at subsequent visits. All participants were followed until sweating returned to baseline levels. This trial was initially conceived as a placebo-controlled study; however, owing to the insufficient size of the placebo group, the placebo arm of this trial was dropped during data analysis. The main outcome measures were safety, efficacy, and duration of effect. RESULTS: According to participant assessment of axillary hyperhidrosis improvement (A-HI) and quality of life (A-HQOL) scores and the physician assessment scores, a significant difference was observed in treatment response at Day 30 in the participants receiving Myobloc (botulinum toxin type B) injections. Duration of action ranged from 2.2 to 8.1 months (mean 5.0 months). The adverse event profile included bruising, flu-like symptoms, and dry eyes. CONCLUSION: Myobloc (botulinum toxin type B) proved to be safe and efficacious for the treatment of bilateral axillary hyperhidrosis. More studies are needed to assess the duration of response using different doses of Myobloc (botulinum toxin type B).

Adolescent↗

Double-blind, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B) for the treatment of palmar hyperhidrosis.

BACKGROUND: Palmar hyperhidrosis is a problem of unknown etiology that affects patients both socially and professionally. Botulinum toxin type B (Myobloc), approved by the Food and Drug Administration for use in the treatment of cervical dystonia in the United States in December 2000, has subsequently been used effectively in an off-label indication to treat hyperhidrosis. There are sparse data, however, in the literature evaluating the safety and efficacy of BTX-B for the treatment of palmar hyperhidrosis. OBJECTIVE: We evaluated the safety and efficacy of Myobloc in the treatment of bilateral palmar hyperhidrosis. This was a double-blind, randomized, placebo-controlled study to report on the safety and efficacy of Myobloc. METHODS: Twenty participants (10 men, 10 women) diagnosed with palmar hyperhidrosis were injected with either Myobloc (5,000 U per palm) or a 1.0 mL vehicle (100 mM NaCl, 10 mM succinate, and 0.5 mg/mL human albumin) into bilateral palms (15 Myobloc, 5 placebo). The participants were followed until sweating returned to baseline levels. The main outcome measures were safety, efficacy versus placebo, and duration of effect. RESULTS: A significant difference was found in treatment response at day 30, as determined by participant assessments, between 15 participants injected with Myobloc and 3 participants injected with placebo. The duration of action, calculated in the 17 participants who received Myobloc injections and completed the study, ranged from 2.3 to 4.9 months, with a mean duration of 3.8 months. The single most reported adverse event was dry mouth or throat, which was reported by 18 of 20 participants. The adverse event profile also included indigestion or heartburn (60%), excessively dry hands (60%), muscle weakness (60%), and decreased grip strength (50%). CONCLUSION: Myobloc proved to be efficacious for the treatment of palmar hyperhidrosis. Myobloc had a rapid onset, with most participants responding within 1 week. The duration of action ranged from 2.3 to 4.9 months, with a mean of 3.8 months. The adverse event profile included dry mouth, indigestion or heartburn, excessively dry hands, muscle weakness, and decreased grip strength.

Adult↗

Open-label pilot study of alitretinoin gel 0.1% in the treatment of photoaging.

Alitretinoin (9-cis-retinoic acid) is an FDA-approved topical therapy for the treatment of Kaposi sarcoma. Alitretinoin is a naturally occurring endogenous retinoid that binds to and activates all known intracellular retinoic acid receptor (RAR) subtypes alpha, beta, and gamma and retinoic X receptor (RXR) subtypes alpha, beta, and gamma. Photoaging of the skin is the result of accumulated exposure to solar UV radiation. Several topically applied retinoids have been proven clinically effective for treating the appearance of photoaging. Tretinoin and tazarotene, which have been shown to improve photodamaged skin, bind RAR subtypes only. The theoretic benefit of alitretinoin gel 0.1% (Panretin) in the treatment of photoaged skin stems from the binding and activation of both RARs and RXRs, which promote the repair mechanisms in damaged skin. The objective of this study was to evaluate the safety and efficacy of topical alitretinoin gel 0.1% in the treatment of photodamaged skin. The treatment was well tolerated by participants (N=20) and subjectively showed improvement of benign skin lesions (eg, seborrheic keratoses) and precancerous lesions (eg, actinic keratoses). Larger, blinded, controlled trials are needed to investigate the role of this novel retinoid in the treatment of photoaging.

Administration, Topical↗

Dermal fillers.

The new bioengineered human collagen products and the various hyaluronic acid (HA) fillers are all safe and effective agents for soft tissue augmentation. There is no one best filler for all purposes and optimal results are achieved by using these products in various combinations. In my opinion, HA-containing products provide volume while collagen products are better suited to provide structural support. Less downtime is associated with the collagen products, due to the platelet-aggregating effects of collagen and the eosinophil-stabilizing effects of lidocaine. Using collagen in combination with HA, during the same office visit, may help reduce some of the bruising and swelling seen with HA alone.

Journal Article↗

Botulinum toxin type B (Myobloc).

Myobloc, known as Neurobloc in Europe, is a member of the botulinum toxin family. It has been used for a myriad of problems since its approval in the United States in December 2000. It is currently not approved for cosmetic use but has been used for this purpose. This article reviews what is currently known about botulinum toxin type B and its efficacy and safety.

Animals↗

A double-blinded, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B)-purified neurotoxin complex for the treatment of crow's feet: a double-blinded, placebo-controlled trial.

Crow's feet develop with age and are one of the earliest signs of the normal aging process. Botulinum toxin type A, approved by the Food and Drug Administration for the treatment of glabellar wrinkles in April 2002, has been used off-label to treat facial wrinkles since 1981. Botulinum toxin type B (BTX-B, Myobloc) was Food and Drug Administration-approved for use in cervical dystonia in the United States in December 2000 and has subsequently been used in an off-label indication to treat facial wrinkles. There are sparse data in the literature evaluating the safety and efficacy of BTX-B for the treatment of facial wrinkles. In this pilot study, participants with moderate or severe crow's feet wrinkles were treated with Myobloc versus placebo. The duration of correction and side effect profile are reported.

Adult↗

Cryoanalgesia with dichlorotetrafluoroethane lessens the pain of botulinum toxin injections for the treatment of palmar hyperhidrosis.

BACKGROUND: Hyperhidrosis is a troublesome problem that can be embarrassing in both social and professional situations. Botulinum toxin injections have proven efficacious in the treatment of hyperhidrosis. However, when treating palmar hyperhidrosis, pain at the injection site limits this therapy. We describe a method of cryoanalgesia using dichlorotetrafluoroethane to lessen the pain of botulinum toxin injections during the treatment of palmar hyperhidrosis. OBJECTIVE: To show the successful use of dichlorotetrafluoroethane or Frigiderm in the treatment of palmar hyperhidrosis. METHODS: This is a case report of a patient with a 20-year history of palmar hyperhidrosis who had previously tried several unsuccessful techniques to control pain during botulinum toxin injections to his palms. The left hand of the patient was pretreated with a spray of Frigiderm for 5 seconds before each of the botulinum injections. Two to 3 seconds of dichlorotetrafluoroethane at a distance of 2 to 4 inches were sprayed before each palmar injection. There was 1 to 2 seconds of frosting on the skin before the botulinum toxin was administered. After the botulinum toxin injection was administered, the patient was subjectively asked about pain during injection. RESULTS: The patient subjectively reported a 75% decrease in the intensity of pain with the Frigiderm application, which he said made the injections much more tolerable. No epidermal changes were noted at the time of treatment or at the telephone follow-up visit. The patient presented for follow-up 3 months later. He stated that the sweating had minimally returned but that he had not yet returned to baseline. CONCLUSION: The use of botulinum toxin for the treatment of palmar hyperhidrosis is often limited because of the pain of multiple injections. In this case report, we describe the successful use of cryoanalgesia with dichlorotetrafluoroethane or Frigiderm to lessen the pain of botulinum toxin injections during the treatment of palmar hyperhidrosis.

Aerosol Propellants↗

Efficacy and safety of a new triple-combination agent for the treatment of facial melasma.

Treatment of melasma, a hyperpigmentation disorder, remains a challenge. The primary objective of two 8-week, multicenter, randomized, investigator-blind studies was to compare the efficacy and safety of a hydrophilic cream formulation containing tretinoin 0.05%, hydroquinone 4.0%, and fluocinolone acetonide 0.01% (RA+HQ+FA) with the dual-combination agents tretinoin plus hydroquinone (RA+HQ), tretinoin plus fluocinolone acetonide (RA+FA), and hydroquinone plus fluocinolone acetonide (HQ+FA). All agents had the same drug concentration and vehicle. A total of 641 adult patients, predominantly female, with moderate to severe melasma and Fitzpatrick skin types I through IV, were randomized to the various treatment groups. Due to the similarity of the study designs, the results of the 2 studies were combined and are reported here. The primary efficacy analysis involved the proportion of intent-to-treat patients in each treatment group whose condition had completely cleared by week 8. The results of the combined clinical trials demonstrated that significantly more of the patients treated with RA+HQ+FA (26.1%) experienced complete clearing compared with the other treatment groups (4.6%) at the end of week 8 (P<.0001). In addition, at week 8, a 75% reduction in melasma/pigmentation was observed in more than 70% of patients treated with RA+HQ+FA compared with 30% in patients treated with the dual-combination agents. The most common adverse reactions seen with all treatment groups were erythema, skin peeling, burning, and/or stinging sensation. The majority of treatment-related adverse events were of mild severity.

Administration, Topical↗

Effects of topical arnica gel on post-laser treatment bruises.

BACKGROUND: Claims have been made suggesting that topical arnica prevents and speeds the resolution of bruises, yet there are no well-designed placebo-controlled studies to date evaluating topical arnica's effect on bruising. OBJECTIVE: To compare the efficacy of topical arnica in the prevention and resolution of laser-induced bruising. METHODS: Nineteen patients with facial telangiectases were enrolled in this randomized, double-blinded, placebo-controlled study and were divided into pretreatment and posttreatment groups. The pretreatment group applied arnica with vehicle to one side of the face and vehicle alone to the other side of the face twice a day for 2 weeks prior to laser treatment. The posttreatment group followed the same procedure for 2 weeks after laser treatment. On day 0, all patients were treated for facial telangiectases using a 585 nm pulsed dye laser. Bruising was assessed using a visual analog scale on days 0, 3, 7, 10, 14, and 17 by the patient and the physician. In addition, photographs taken at each of the follow-up visits were later assessed by a second physician using the visual analog scale. RESULTS: There was no statistically significant difference between the mean scores of arnica and vehicle (P = 0.496) and the mean scores of arnica and vehicle (P = 0.359) in the pretreatment and posttreatment groups, respectively. CONCLUSION: No significant difference was found between topical arnica and vehicle in the prevention or resolution of bruising.

Administration, Topical↗

The effects of topical vitamin K on bruising after laser treatment.

BACKGROUND: Pulsed dye laser treatment and other cosmetic procedures result in significant bruising. Claims have been made regarding the efficacy of topical vitamin K in both preventing and speeding the clearing of bruising; however, well-controlled studies are lacking. OBJECTIVE: The purpose of this study is to evaluate the effects of topical vitamin K versus placebo in the prevention and clearing of laser-induced purpura. METHODS: A total of 22 patients were enrolled in this double-blind randomized placebo-controlled study. The patients were divided into pretreatment and posttreatment groups; the 11 patients in the former group applied vitamin K cream to half of their face and vehicle alone to the other half of their face twice daily for 2 weeks before laser treatment. The latter group followed the same procedure for 2 weeks after laser treatment. On day 0, all subjects underwent laser treatment for facial telangiectases using a 585-nm pulsed dye laser. Bruising was rated by the both the patient and physician by means of a visual analogue scale on days 0, 3, 7, 10, 14, and 17. RESULTS: The side of the face treated with topical vitamin K before laser therapy showed no significant difference in bruising as compared to placebo. However, the side of the face treated with vitamin K cream after laser treatment had significantly lower scores of bruising severity when compared with the side treated with placebo. CONCLUSION: Although pretreatment with vitamin K did not prevent bruising after laser treatment, use of vitamin K cream after laser treatment did reduce the severity of bruising, particularly in the initial days of application.

Administration, Topical↗

Collagen fillers.

Collagen implants, both animal and human derived, have been used for soft tissue augmentation for many years. Bovine collagen fillers were the most popular injectable implants for nearly two decades in the United States. Since then, human bioengineered collagen products have been available in addition to hyaluronic acid-containing fillers. This article outlines the different types of injectable collagen implants, injection techniques, preferred methods of treatment, and possible adverse reactions to the injectable materials.

Biocompatible Materials↗

A large 12-month extension study of an 8-week trial to evaluate the safety and efficacy of triple combination (TC) cream in melasma patients previously treated with TC cream or one of its dyads.

This was a 12-month extension of a randomized, investigator-blinded, multicenter, 8-week trial with triple combination (TC) cream in facial melasma. A total of 585 patients were enrolled in the study and 569 patients received study medication. Three hundred eighty-nine patients completed 6 months of treatment and 327 patients completed 12 months of treatment. TC cream demonstrated a favorable safety profile: only 14 patients (2.5%) discontinued the study due to treatment-related adverse events (AEs). The 2 cases of skin atrophy were mild and did not lead to withdrawal. From the 23 cases of mild telangiectasia, only 2 resulted in discontinuation. All others were transient. Results confirmed those of a previous smaller study, with both physicians and patients reporting clinically significant improvements in melasma. By month 12, 80% of patients had lesions completely cleared or nearly cleared. Once daily application of TC cream applied intermittently over a long period is a safe, tolerable, and effective treatment for moderate to severe melasma of the face.

Administration, Topical↗