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.

T-cell clonality of peripheral blood lymphocytes in patients with lymphomatoid papulosis.

Six patients with lymphomatoid papulosis demonstrated a clonal T-cell population in skin lesions by polymerase chain reaction methods. Two of these patients showed identical T-cell clones in their peripheral blood T cells as well. In one case, the clone persisted in the blood despite clearing of skin lesions with methotrexate.

Cutaneous and oral eruption from oral exposure to nickel in dental braces.

Oral eruptions due to nickel allergy are rare. A common presentation of intraoral contact dermatitis is the presence of lichenoid plaques on the buccal mucosa adjacent to the offending antigen. We report an unusual case of cutaneous and mucosal nickel allergy arising after placement of dental braces. An 11-year-old boy was referred by his orthodontist to the University of Minnesota Occupational and Contact Dermatitis Clinic to be evaluated for a possible metal allergy. The patient developed an itchy rash on his abdomen and under his wristwatch 1 week after dental braces were placed. He was diagnosed with allergic contact dermatitis from nickel. The patient avoided cutaneous nickel exposure and had a minimal resolution of his symptoms. One year later, the patient developed swelling and burning of the lips. Secondary to extreme discomfort, the braces, which contained nickel, titanium, and zinc, were removed. The patient underwent standard patch testing; the final reading at 96 hours showed a +++ reaction to nickel, palladium, cobalt chloride, and neomycin. The patient experienced relief of his oral symptoms after removal of the braces. No current relevance to palladium, cobalt, or neomycin has been found.