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Biomedical subjects

Mark Lebwohl

Publications and source records attributed to Mark Lebwohl.

At least 55 records · Page 3Linked to original sources
PubMed2004

Safety and efficacy of ciclopirox 1% shampoo for the treatment of seborrheic dermatitis of the scalp in the US population: results of a double-blind, vehicle-controlled trial.

BACKGROUND: Seborrheic dermatitis is a common inflammatory skin disorder. Yeasts of the genus Malassezia have been implicated in the etiology of seborrheic dermatitis, although this connection remains controversial. Ciclopirox is a synthetic, hydroxypyridone-derived, broad-spectrum antifungal agent with anti-inflammatory properties. METHODS: A total of 499 US patients with seborrheic dermatitis of the scalp were randomized to apply either ciclopirox shampoo 1% or vehicle twice weekly for 4 weeks. The main efficacy parameters were based on 6-point ordinal scales describing the disease's signs and symptoms (scaling, erythema and itching) and a 6-point scale providing a global evaluation of the status of seborrheic dermatitis. RESULTS: Ciclopirox was significantly better than vehicle in effectively treating seborrheic dermatitis. 'Effective treatment' (score of 0 or 1 for disease status, scaling and erythema) was achieved in 26.0% of ciclopirox-treated patients compared with 12.9% of vehicle-treated patients (P = 0.0001; OR: 2.383, 95% CI: 1.494-3.799). The majority of subjects experienced adverse events that were mild in intensity, with skin and appendage reactions the most commonly reported, at similar frequency in both groups. CONCLUSIONS: Ciclopirox shampoo 1% is effective and safe in the treatment of seborrheic dermatitis of the scalp.

Administration, Cutaneous↗
PubMed2004

The use of the 308-nm excimer laser for the treatment of vitiligo.

BACKGROUND: Recent reports show that 308-nm excimer laser may be an effective and safe method for the treatment of vitiligo, which is usually resistant to other available treatment methods. OBJECTIVE: The objective was to study the effectiveness of the new 308-nm excimer laser for the treatment of vitiligo. METHODS: A retrospective chart review of thirty-two patients with 55 spots of vitiligo were enrolled; a population-based sample was studied that included men and women, adults and children, with different ethnic backgrounds. The treatment was started with the lowest dose, which is 100 mJ/cm(2) (comparable to one minimal erythema dose value and one multiplier). Depending on Fitzpatrick skin type, the dose was raised gradually in a stepwise fashion. In skin types I to II, the same does was repeated twice before going up to avoid burns. Patients were treated for 30 sessions, or 75% repigmentation, whichever comes first. RESULTS: Overall 55 spots were treated: 29 (52.8%) had 75% pigmentation or greater, and 35 (63.7%) had 50% pigmentation or greater. The best results were on the face: of the 21 spots treated 15 (71.5%) had 75% pigmentation, and 16 (76.2%) had 50% pigmentation or greater. Other areas (neck, extremities, trunk, and genitals) had moderate response in comparison to the face. The least response was on the hands and feet; of the 5 spots treated only 20% showed 50% pigmentation or more. CONCLUSION: Slightly more than 50% of the patients tested showed 75% or more pigmentation of their lesions, after 30 treatments or less; most of the responders had Fitzpatrick skin type III and above. All the untreated patches (controls) remained unchanged. This demonstrates that the 308-nm excimer laser is an effective method of treatment for vitiligo.

Adolescent↗
PubMed2004

Tacrolimus ointment in the treatment of eyelid dermatitis.

The safety and efficacy of tacrolimus ointment 0.1% (Protopic) in the treatment of atopic dermatitis of the eyelids were assessed in an open-label clinical trial of 21 patients with moderate to severe eyelid dermatitis. Of those 21 patients, 20 received study drug and were followed. Patients applied tacrolimus ointment 0.1% twice daily for 8 weeks and were followed for 2 additional weeks after the last day of treatment. Complete eye examinations were conducted throughout the study. Efficacy was assessed through the investigator's evaluation of the patients' individual signs and symptoms of eyelid dermatitis and the physician global assessment (PGA) of eyelid clinical response. Improvement in the investigator's evaluation of the signs and symptoms of eyelid dermatitis was observed during the study. A total of 80% of patients (16/20) experienced marked improvement or better in PGA at 8 weeks. Adverse events were limited to local burning and itching after the first few applications of study medication. Of the 20 patients, 12 reported burning (60%), and 5 reported itching (25%). There was no statistically significant increase in intraocular pressure (IOP) during the study compared with baseline. In addition, none of the patients developed cataracts or glaucoma during the study. In summary, tacrolimus ointment 0.1% may be a safe and effective treatment option for patients with moderate to severe eyelid dermatitis.

Administration, Topical↗
PubMed2003

A novel targeted T-cell modulator, efalizumab, for plaque psoriasis.

BACKGROUND: Interactions between leukocyte-function-associated antigen type 1 (LFA-1) and intercellular adhesion molecules are important in the pathogenesis of psoriasis. Efalizumab, a humanized monoclonal antibody, binds to the alpha subunit (CD11a) of LFA-1 and inhibits the activation of T cells. METHODS: In a phase 3, multicenter, randomized, placebo-controlled, double-blind study, we assign 597 subjects with psoriasis to receive subcutaneous efalizumab (1 or 2 mg per kilogram of body weight per week) or placebo for 12 weeks. Depending on the response after 12 weeks, subjects received an additional 12 weeks of treatment with efalizumab or placebo. Study treatments were discontinued at week 24, and subjects were followed for an additional 12 weeks. RESULTS: At week 12, there was an improvement of 75 percent or more in the psoriasis area-and-severity index in 22 percent of the subjects who had received 1 mg of efalizumab per kilogram per week and 28 percent of those who had received 2 mg of efalizumab per kilogram per week, as compared with 5 percent of the subjects in the placebo group (P<0.001 for both comparisons). Efalizumab-treated subjects had greater improvement than those in the placebo group as early as week 4 (P<0.001). Among the efalizumab-treated subjects who had an improvement of 75 percent or more at week 12, improvement was maintained through week 24 in 77 percent of those who continued to receive efalizumab, as compared with 20 percent of those who were switched to placebo (P<0.001 for both comparisons). After the discontinuation of efalizumab at week 24, an improvement of 50 percent or more in the psoriasis area-and-severity index was maintained in approximately 30 percent of subjects during the 12 weeks of follow-up. Efalizumab was well tolerated, and adverse events were generally mild to moderate. CONCLUSIONS: Efalizumab therapy resulted in significant improvements in plaque psoriasis in subjects with moderate-to-severe disease. Extending treatment from 12 to 24 weeks resulted in both maintenance and improvement of responses.

Adult↗
PubMed2003

Synergistic enhancement of H2O2 production in human epidermoid carcinoma cells by Benzo[a]pyrene and ultraviolet A radiation.

Benzo[a]pyrene (BaP) is an ubiquitous environmental pollutant with potential carcinogenecity. It was shown that BaP, upon irradiation by UV A, enhanced the formation of 8-hydroxy-2'-deoxyguanosine in purified DNA and in cultured cells. The purpose of this present study was to determine whether BaP and UV radiation synergistically generate reactive oxygen species (ROS) that consequently result in the oxidation of DNA bases. In this study, the levels of H(2)O(2) were measured as an indicator of ROS in A431 cells and primary human keratinocytes treated with BaP plus UV radiation. Production of H(2)O(2) significantly increased from cells treated with BaP plus UVB or UVA, with the latter having a much greater effect. The responses of A431 cells and primary human keratinocytes to BaP and UVA irradiation were similar in generation of extracellular H(2)O(2). Also, H(2)O(2) production proportionally correlated with UVA and UVB dose, but was independent of time or BaP concentration. Treatment with catalase and general ROS scavengers significantly decreased H(2)O(2) production from cells treated with BaP plus UVA, whereas scavengers of *O2-, *OH, and (1)O(2) had minimal effects. These results demonstrate that BaP synergistically enhances the production of H(2)O(2) from cultured cells by UVA and, to a lesser extent, by UVB, supporting the hypothesis that interaction of BaP and UVA can generate ROS and further substantiate oxidative DNA damage that may lead to carcinogenesis.

Antioxidants↗
PubMed2003

Psoriasis.

Recent breakthroughs in the treatment of psoriasis have led to improved understanding of the pathogenesis of this disease. Activation of T lymphocytes leading to release of cytokines results in proliferation of keratinocytes. Several new biological therapies have been developed, which target specific steps in the pathogenesis of psoriasis. With these new treatments, variable degrees of clearing occur. Initial data suggest improved safety over older agents such as methotrexate and ciclosporin, but long-term data are necessary. Enhancements in topical therapy and phototherapy have also increased the armamentarium of treatments available for this disorder.

Antibodies, Monoclonal↗
PubMed2003

An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis.

BACKGROUND: Alefacept, human lymphocyte function-associated antigen 3/immunoglobulin 1 fusion protein, binds to CD2 molecules on the surface of activated T cells, selectively targeting memory-effector (CD45RO+) T cells, which comprise more than 75% of T cells in psoriatic plaques. OBJECTIVE: To examine the efficacy and tolerability of intramuscular alefacept. DESIGN: International, randomized, double-blind, placebo-controlled, parallel-group trial. PATIENTS: A total of 507 patients with chronic plaque psoriasis. INTERVENTION: Placebo, 10 mg of alefacept, or 15 mg of alefacept administered once weekly for 12 weeks followed by 12 weeks of observation. MAIN OUTCOME MEASURE: Psoriasis Area Severity Index (PASI). RESULTS: Alefacept treatment was associated with dose-related significant improvements in PASI from baseline. Throughout the study, a greater percentage of patients in the 15-mg group than in the placebo group achieved a significant reduction in PASI. Of patients in the 15-mg group who achieved at least 75% PASI reduction 2 weeks after the last dose, 71% maintained at least 50% improvement in PASI throughout the 12-week follow-up. There were no opportunistic infections and no cases of disease rebound. CONCLUSION: Intramuscular administration of alefacept was a well-tolerated and effective therapy for chronic plaque psoriasis and thus represents a convenient alternative to intravenous dosing.

Adolescent↗
PubMed2003

Pseudoxanthoma elasticum: Temporary treatment of chin folds and lines with injectable collagen.

Pseudoxanthoma elasticum is characterized by calcification of dermal connective tissues. Typical rhytides and horizontal creases of the chin are cutaneous manifestations that begin at an early age and are often overlooked. We report 2 patients with pseudoxanthoma elasticum who had characteristic rhytides and horizontal creases of the chin ("mental" creases). Rhytides and horizontal creases were successfully treated with injectable collagen.

Collagen↗
PubMed2003

Combining the new biologic agents with our current psoriasis armamentarium.

Combination therapy, rotational therapy, and sequential therapy have been used for psoriasis in attempts to achieve greater efficacy and greater safety. The purpose of this manuscript is to review potential advantages and disadvantages of new biologic agents as we look forward to their use in combination regimens with other systemic, topical, and light therapies. Data on the efficacy and toxicity of existing systemic therapies and new biologic agents is reviewed with an emphasis on potential additive or synergistic benefits or toxicities. The mechanism of action of biologic agents differs from systemic agents currently in use, suggesting that there may be additive effects in treating psoriasis. The absence of hepatotoxicity and nephrotoxicity are important advantages when considering combination therapy with biologic agents. The advantages of the use of biologic therapies in combination or rotation with other systemic agents will have to be demonstrated in clinical trials. Mechanisms of action of the biologic therapies suggest that there is potential for additive benefit when used in combination regimens.

Alefacept↗
PubMed2003

Daily UVB exposure levels in high-school students measured with digital dosimeters.

UV radiation exposure increases skin cancer risk. A substantial portion of a person's UV exposure occurs before the age of 18 years. We sought to determine UVB radiation exposure levels in high-school students during normal daily activity. Digital dosimeters were worn by 4 high-school students during 11 school days. Students were subjected to daily erythemal and suberythemal doses of UVB radiation. Programs to educate high-school students in sun-protective practices even during regular school activities are needed.

Adolescent↗
PubMed2003

Newly available treatments for psoriatic arthritis and their impact on skin psoriasis.

Far from being a "benign" arthropathy, as it was initially characterized, psoriatic arthritis (PsA) affects approximately 0.2% of the US population and can be associated with considerable joint damage, symptomatology, and quality of life impairment. PsA shares many characteristics with rheumatoid arthritis (RA), and new, rationally designed drugs that are effective in RA also are proving active in PsA. Two such drugs, etanercept and infliximab, target tumor necrosis factor (TNF), a key component of the inflammatory response. This review discusses the rationale for and experience with the use of these agents in PsA. Etanercept is a dimeric fusion protein that binds specifically to TNF, blocking its interaction with cell surface TNF receptors. Infliximab is a chimeric (murine/human) monoclonal antibody that binds to TNF and inhibits its binding to its receptor. A randomized placebo-controlled trial of etanercept in PsA found statistically significant benefits for this agent in measures of arthritic activity and psoriatic severity. There have been anecdotal reports of the efficacy of infliximab in PsA, but results from controlled clinical trials of this agent in PsA have not been reported. TNF inhibitors represent new therapeutic options for patients with PsA. The potential advantages of treatment with etanercept and infliximab early in the disease course are discussed.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2003

Topical calcitriol is degraded by ultraviolet light.

Calcitriol ointment has been approved for the treatment of psoriasis in many countries around the world. It may be prescribed in conjunction with phototherapy. Our purpose was to evaluate the effect of various therapeutic ultraviolet modalities on the stability of calcitriol and, conversely, to study the effects of calcitriol ointment on transmission of different forms of ultraviolet light. Calcitriol ointment 3 microg per g was irradiated with 10 J per cm2 ultraviolet A, 100 mJ per cm2 broadband ultraviolet B, and 3.0 J per cm2 narrowband ultraviolet B, and its stability was compared with samples exposed to fluorescent light and ambient sunlight. Ultraviolet A and ultraviolet B transmission were measured through thin and thick layers of calcitriol 3 microg per g ointment and vehicle. More than 90% of calcitriol ointment is degraded upon exposure to ultraviolet A, broadband ultraviolet B, and narrowband ultraviolet B. Transmission of ultraviolet A is reduced through calcitriol ointment and its vehicle by 17%-31% and 17%-41%, respectively. Transmission of ultraviolet B is reduced by 67%-87% through vehicle and 50%-83% through calcitriol ointment. When used in conjunction with phototherapy, calcitriol ointment should be applied after ultraviolet exposure, not before. Calcipotriene, the only vitamin D analog already approved for psoriasis in the USA, has been used successfully in combination with ultraviolet B and psoralen plus ultraviolet A.

Administration, Topical↗
PubMed2003

Tacrolimus ointment for the treatment of psoriasis on the face and intertriginous areas.

The safety and efficacy of 0.1% tacrolimus ointment for the treatment of psoriasis on the face, intertriginous areas, or both were evaluated in an open-label, clinical trial of 21 patients with psoriasis. Patients applied 0.1% tacrolimus ointment twice daily for 8 weeks. Efficacy was assessed through the investigator's evaluation of the individual signs and symptoms of psoriasis, and the physician's global evaluation of change in disease status. Assessments of cutaneous atrophy and other adverse events were made throughout the study to evaluate the safety of tacrolimus ointment. A total of 21 patients were enrolled in the study; 21 patients at least 18 years of age received study medication. Statistically significant improvement in the physician's assessment of the individual signs and symptoms was observed during the study. A total of 81% of patients (17 of 21) experienced complete clearance at day 57 (end of treatment). Only 2 patients reported adverse events, which were limited to itching and the feeling of warmth at the application site. None of the patients had atrophy, telangiectasia, or striae develop during the study. In summary, tacrolimus 0.1% ointment may be a safe and effective treatment option for patients with psoriasis on the face, intertriginous areas, or both.

Administration, Topical↗
PubMed2003

Mammographic findings in pseudoxanthoma elasticum.

BACKGROUND: There have been isolated case reports of arterial and skin calcification in mammograms of patients with pseudoxanthoma elasticum (PXE), and unpublished anecdotes of many women with PXE undergoing breast biopsy for evaluation of microcalcifications. OBJECTIVE: Our aim was to systematically evaluate mammography and breast pathology in PXE. METHODS: The mammograms of 51 women with confirmed PXE were compared with those of a control sample of 109 women without PXE, noting each of the following characteristics on each mammogram: breast density, skin thickening, skin microcalcifications, vascular calcification, breast microcalcifications and macrocalcifications, and masses. The characteristics of the 2 samples were compared using the 2-tailed t test with a pooled estimate of variance. The indications for mammography and data for each of the mammographic findings were analyzed using the chi(2) test. Available breast biopsy material was reviewed. RESULTS: The PXE and control groups were similar in age and indications for mammography. There was a statistically significant increase in skin thickening, vascular calcification, and breast microcalcifications in the PXE group (P <.001 each). Breast density, masses, macrocalcifications, and skin calcification did not differ statistically in the 2 groups, but no control patient had axillary calcification, or both vascular calcification and microcalcifications (P <.001). Nearly 1 in 7 of the patients with PXE demonstrated at least 3 of the following: microcalcifications, skin calcifications, vascular calcification, and skin thickening; whereas none of the control group did. Histopathologic findings of breast tissue showed calcification of dermal elastic fibers, subcutaneous arteries, and elastic fibers of the deep fascia and interlobular septae of the fat adjacent to breast parenchyma. CONCLUSION: Breast microcalcification and arterial calcification are not rare in the normal population and are not of diagnostic value. The presence of both of these findings, especially with skin thickening or axillary skin calcification, should suggest a diagnosis of PXE. The majority of breast calcifications in PXE are benign.

Adult↗
PubMed2003

Prominent mental (chin) crease: a new sign of pseudoxanthoma elasticum.

Pseudoxanthoma elasticum (PXE) is an inherited disease with many systemic complications. Its diagnosis can be easily overlooked. The purpose of this study was to assess a new clinical sign of PXE. A total of 47 consecutive patients with PXE were examined for mental creases and compared with 47 age-matched control patients. Photographs were evaluated by a blinded investigator. Mental creases were present in 43 of 47 patients with PXE, affected the majority of individuals in every age group, and were significantly more common than in control patients (P <.0001). Under the age of 30 years, two thirds of patients with PXE had mental creases whereas mental creases were not present in any age-matched control patients. Mental creases commonly occur in patients with PXE. In young patients they are a sensitive and highly specific physical finding of this disorder. The presence of exaggerated mental creases is, thus, a useful physical marker for PXE.

Adolescent↗
PubMed2003

Cost-effectiveness analysis of tacrolimus ointment versus high-potency topical corticosteroids in adults with moderate to severe atopic dermatitis.

BACKGROUND: Few cost-effectiveness analyses have been conducted on topical therapies for atopic dermatitis. OBJECTIVE: We sought to compare cost-effectiveness of high-potency topical corticosteroids (HPTCs) and tacrolimus ointment for the treatment of moderate to severe atopic dermatitis for patients who are not responsive to or not well controlled with mid-potency topical corticosteroids. METHODS: A Markov model represented the cyclic nature of atopic dermatitis. Clinical outcomes were derived from published literature. "Efficacy" was defined as disease-controlled days on which patients experienced a greater than 75% improvement in their disease. Resource use and changes in management were on the basis of opinions of a physician panel; secondary treatment was an oral antibiotic with topical corticosteroids. Sensitivity analyses were conducted for all variables. RESULTS: The model was sensitive to duration of continuous treatment with HPTCs. HPTCs, when limited to 2-week treatment cycles, were associated with the highest total costs ($1682 per year) and the least efficacy (185 disease-controlled days). HPTCs in 4-week treatment intervals and tacrolimus ointment were similar in total costs and efficacy ($1317 vs $1323 for 194 vs 190 disease-controlled days, respectively). Although primary drug costs were higher for patients treated with tacrolimus ointment, patients treated with regimens of HPTCs incurred higher secondary drug costs. CONCLUSION: In the base case analyses, tacrolimus ointment was more cost-effective than HPTCs administered in 2-week treatment cycles, and similar in cost-effectiveness to 4-week cycles of HPTCs.

Administration, Topical↗
PubMed2003

Case studies in severe psoriasis: A clinical strategy.

Individuals with moderate-to-severe psoriasis perceive that the disease exerts profound emotional, social and physical effects on their lives, and a significant percentage report that they do not consider their treatment sufficiently aggressive. A survey of individuals with a variety of chronic diseases reveals that those with psoriasis have the lowest estimation of their health-related quality of life, lower than that of patients with arthritis, congestive heart failure, chronic lung disease or depression. Although psoriasis can be treated effectively, many treatments are associated with long-term risks. Toxicity-sparing treatment strategies that include combination, rotational and sequential regimens can help to control moderate-to-severe psoriasis while reducing risk. Algorithms for the treatment of moderate-to-severe psoriasis detail possible options for specific types of psoriasis and for patients with specific needs. The purpose of the algorithms is to make optimum use of phototherapy, traditional cytotoxic and immunosuppressive agents, retinoids, and newer biologic agents.

Acitretin↗