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Results of a randomized, double-blind, vehicle-controlled efficacy trial of pimecrolimus cream 1% for the treatment of moderate to severe facial seborrheic dermatitis.
J Am Acad Dermatol 2007; 57(2):257-64JA

Abstract

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.

Authors+Show Affiliations

Minneapolis Department of Veterans Affairs Medical Center, University of Minnesota, Minneapolis MN 55417, USA. Erin.Warshaw@med.va.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

17188780

Citation

Warshaw, Erin M., et al. "Results of a Randomized, Double-blind, Vehicle-controlled Efficacy Trial of Pimecrolimus Cream 1% for the Treatment of Moderate to Severe Facial Seborrheic Dermatitis." Journal of the American Academy of Dermatology, vol. 57, no. 2, 2007, pp. 257-64.
Warshaw EM, Wohlhuter RJ, Liu A, et al. Results of a randomized, double-blind, vehicle-controlled efficacy trial of pimecrolimus cream 1% for the treatment of moderate to severe facial seborrheic dermatitis. J Am Acad Dermatol. 2007;57(2):257-64.
Warshaw, E. M., Wohlhuter, R. J., Liu, A., Zeller, S. A., Wenner, R. A., Bowers, S., ... Parneix-Spake, A. (2007). Results of a randomized, double-blind, vehicle-controlled efficacy trial of pimecrolimus cream 1% for the treatment of moderate to severe facial seborrheic dermatitis. Journal of the American Academy of Dermatology, 57(2), pp. 257-64.
Warshaw EM, et al. Results of a Randomized, Double-blind, Vehicle-controlled Efficacy Trial of Pimecrolimus Cream 1% for the Treatment of Moderate to Severe Facial Seborrheic Dermatitis. J Am Acad Dermatol. 2007;57(2):257-64. PubMed PMID: 17188780.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Results of a randomized, double-blind, vehicle-controlled efficacy trial of pimecrolimus cream 1% for the treatment of moderate to severe facial seborrheic dermatitis. AU - Warshaw,Erin M, AU - Wohlhuter,Ross Jon, AU - Liu,An, AU - Zeller,Sarah A, AU - Wenner,Rachel A, AU - Bowers,Sacharitha, AU - Schultz,Julie C, AU - Katz,H Irving, AU - McCormick,Calogera L, AU - Parneix-Spake,Anne, Y1 - 2006/12/22/ PY - 2006/09/08/received PY - 2006/10/24/revised PY - 2006/11/03/accepted PY - 2006/12/26/pubmed PY - 2007/8/1/medline PY - 2006/12/26/entrez SP - 257 EP - 64 JF - Journal of the American Academy of Dermatology JO - J. Am. Acad. Dermatol. VL - 57 IS - 2 N2 - 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. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/17188780/Results_of_a_randomized_double_blind_vehicle_controlled_efficacy_trial_of_pimecrolimus_cream_1_for_the_treatment_of_moderate_to_severe_facial_seborrheic_dermatitis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190-9622(06)04022-9 DB - PRIME DP - Unbound Medicine ER -