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Pimecrolimus Cream 1% (Elidel) Effective and Safe for Facial Seborrheic Dermatitis: Presented at AAD

By Bruce Sylvester

SAN FRANCISCO, C.A. -- March 6, 2006 -- Pimecrolimus cream 1% appears to be an effective treatment for moderate to severe facial seborrheic dermatitis, according to research presented here. The treatment also produced a favorable safety profile.

Researchers presented these findings in a poster session on March 4^th at the 64^th Annual Meeting of the American Academy of Dermatology (AAD).

"Standard treatments for seborrheic dermatitis include antimycotic preparations and topical corticosteroids steroids," the investigators noted in their poster, "and inappropriate use of topical corticosteroids on the face may lead to telangiectasia, skin atrophy and perioral dermatitis." They cited the need to identify a, "new, effective, non-steroid therapy," for treatment of the condition.

The purpose of this double-blind, randomized, vehicle-controlled, single site clinical trial was to evaluate the efficacy and safety of non-steroidal pimecrolimus cream 1% twice daily over 4 weeks for the treatment of moderate to severe facial seborrheic dermatitis.

The investigators enrolled and randomized 96 subjects to receive either pimecrolimus (n=47) or a vehicle cream (n=49). The subjects ranged in age from 20 to 88 years. Baseline demographics were similar in both groups.

The total group included 42 patients with mild disease, 34 patients with moderate disease and 20 patients with severe disease. The vehicle group had 53% mild disease, 31% moderate and 16% severe. The pimecrolimus group had 34% mild disease, 40% moderate and 26% severe.

Per protocol analysis at week 2 for the mean change from baseline in the size of total target area (a measure of erythematic and scaling on a 0-6 scale) showed a significant difference between the two treatment groups. The investigators found a change of -2.6 for vehicle and -3.6 for pimecrolimus (P =.0012).

The same analysis at week 4 also showed a significant difference between the groups, with a change of -3.2 for vehicle and -3.9 for pimecrolimus (P =.0156).

No serious adverse events were reported in the study, according to the researchers.

"The study results suggest that pimecrolimus cream 1% is an effective treatment for moderate to severe facial seborrhea dermatitis," the investigators concluded.

"Pimecrolimus cream 1% was well tolerated in this study of patients with dermatitis of facial skin, a sensitive skin area," they added.

Elidel Cream is a prescription medicine approved by the FDA to for the treatment of eczema (atopic dermatitis). It is in a class of medicines called topical calcineurin inhibitors.

The study was supported by Novartis Pharmaceuticals Corporation.


[Presentation title: Pimecrolimus Cream 1% for the Treatment of Moderate to Severe Facial Seborrheic Dermatitis: A Double-blind, Randomized, Vehicle-controlled Study. Abstract P830]

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