Results of a randomized, double-blind, vehicle-controlled efficacy trial of pimecrolimus cream 1% for the treatment of moderate to severe facial seborrheic dermatitis.

BACKGROUND: Seborrheic dermatitis is commonly treated with anti-inflammatory products, including topical corticosteroids. Pimecrolimus cream 1% also exerts anti-inflammatory activity by inhibiting T-cell cytokine production. OBJECTIVE: We sought to compare the efficacy and safety of twice-daily pimecrolimus for treatment of moderate to severe facial seborrheic dermatitis. METHODS: This double-blind, vehicle-controlled, 4-week trial randomized patients with seborrheic dermatitis to pimecrolimus or vehicle (1:1). Clinical assessments (erythema [0-3] and scaling [0-3] combined for a total area score [0-6]) were performed at weeks 0, 2, and 4. Inclusion criteria included total area score 4 or greater and erythema 2 or greater. The prespecified primary variable, change from baseline in total area score at week 4, was analyzed using a two-sample t test for intent-to-treat and per protocol populations. RESULTS: In all, 96 adults of mean age 59.6 years, 88.5% male, were randomized (n = 47 pimecrolimus; 49 vehicle). At week 4, the mean change from baseline in total area score was 3.7 versus 3.3 for pimecrolimus and vehicle groups, respectively (intent-to-treat: P = .1913; 95% confidence interval (CI) for difference [-0.195, 0.961]). Per protocol analysis (n = 41 pimecrolimus; 46 vehicle) indicated a significant difference between groups (mean change 3.9 pimecrolimus vs 3.2 vehicle; P = .0156; CI [0.129, 1.197]). The superiority of pimecrolimus was observed as early as week 2 (intent-to-treat: P = .0062; CI [0.132, 0.777]; per protocol: P = .0012; CI [0.410, 1.593]). No drug-related serious adverse events occurred. The most frequent drug-related adverse events were local, mild, and transient (pimecrolimus = 26%; vehicle = 12%). LIMITATIONS: Generalizability is limited by the elderly male study population. CONCLUSION: This study suggests that pimecrolimus cream 1% is an effective and well-tolerated treatment for moderate to severe facial seborrheic dermatitis.

Evaluation of prospectively collected presenting signs/symptoms of biopsy-proven melanoma, basal cell carcinoma, squamous cell carcinoma, and seborrheic keratosis in an elderly male population.

BACKGROUND: Presenting signs/symptoms of skin cancer may aid in earlier detection and diagnosis. OBJECTIVE: We sought to compare prospectively collected, presenting signs/symptoms of malignant melanoma (MM), basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and seborrheic keratosis (SK). METHODS: This analysis was part of a larger study on teledermatology involving 3039 skin neoplasms in 2152 patients at a Department of Veterans Affairs medical center. At presentation, participants were asked about signs/symptoms of specific skin lesions. In all, 912 biopsy-proven MM (39), BCC (411), SCC (238), and SK (224) were included in this analysis. Pearson chi(2) analyses were used to test associations of lesion type and specific signs/symptoms in pairwise comparisons. RESULTS: "No symptoms" was reported more often with MM (82%) as compared with BCC (relative risk [RR] 2.26, confidence interval [CI] 1.86, 2.75), SCC (RR 3.31, CI 2.54, 4.32), or SK (RR 2.0, CI 1.61, 2.48; all P < .0001). Tenderness was more commonly reported with SCC (40%) as compared with MM (RR 15.9, CI 2.28, 110.69), SK (RR 3.0, CI 2.11, 4.39), or BCC (RR 2.6, CI 1.97, 3.38; all P < .0001). Bleeding was more commonly reported with BCC (37%) as compared with SK (RR 2.3, CI 1.67, 3.20), SCC (RR 1.6, CI 1.22, 2.05), or MM (RR 29.8, CI 1.89, 469.65; all P