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NEUTROGENA COAL TAR/SALICYLIC ACID OTC PSORIASIS STUDY

Executive Summary

NEUTROGENA COAL TAR/SALICYLIC ACID OTC PSORIASIS STUDY will evaluate effectiveness of the combination compared to coal tar and salicylic acid alone, the company told FDA in a recent letter. Neutrogena said the study will be a double-blind comparison of the three treatment regimens in 100 adult patients with a diagnosis of scalp psoriasis. The firms plans to conduct the study at UCLA and Baylor Medical Centers (Dallas, Texas). Neutrogena is proposing the study as support of a Category I classification for a combination of the two ingredients in the final OTC monograph for psoriasis products. Both coal tar and salicylic acid were given Category I status as individual ingredients in the Tentative Final Monograph (TFM), which was published in the July 30 Federal Register; however, the combination was not recognized in the TFM ("The Pink Sheet" Aug. 4, p. 3). FDA noted in the proposed ruling that no data had been submitted to support the efficacy of any combinations for dandruff, seborrhea, or psoriasis. Neutrogena markets a 2% coal tar/2% salicylic acid psoriasis body solution under the trade name T/Gel and is planning to introduce a shampoo formulation (T/Sal) in July. The firm is requesting FDA to hasten review of the protocol so that results can be submitted for the final monograph. Neutrogena's proposed protocol calls for the 100 psoriatics to be randomly assigned to one of three treatment groups: coal tar 2% and salicylic acid 2% in a shampoo formulation, a salicylic acid shampoo, or a coal tar shampoo. The patients will be instructed to use the shampoo nightly for six weeks. Inclusion criteria requires that patients not use systemic scalp psoriasis medications for four weeks prior to the trial or topical scalp psoriasis therapy within two weeks of the trial. Patients will be evaluated by the investigators at baseline, two weeks, four weeks, and six weeks. Treatment effectiveness will be evaluated by scoring improvement in "erythema, thickening, scaling, pruritis and percentage of scalp involvement," the protocol states.
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