J. Soc. Cosmet. Chem., 23, 189-194 (March 3, 1972) A Clinical Evaluation of Two Shampoos in the Treatment of Seborrheic Dermatitis NORMAN ORENTREICH, M.D.* Synopsis--The relative EFFICACIES of a commercially available ZINC PYRITHIONE SHAMPOO a com•nercially available SULFUR, SALICYLIC ACID, and HEXACHLORO- PHENE SHAMPOO and a control shampoo in the "over the counter" treatment of frank SEBORRHEIC DERMATITIS were measured using a visual technique. Both the zinc pyrithione shampoo and the shampoo based on the combination of active ingredients pro- duced better results than the unmedicated control shampoo. Further, the zinc pyrithione shampoo was significantly more effective in controlling this disease process than the shampoo containing the combination of active ingredients. A supplementary evaluation of the rela- tive efficacies of the test products in suppressing itching of the scalp also indicated the zinc pyrithione product to be superior however, the data do not give any evidence of better long- term reduction of scalp oiliness with this shampoo compared to the other active ingredient shampoo. INTRODUCTION Commercial preparations for the treatment of seborrheic dermarl- tis* of the scalp generally include the use of a shampoo, a postshampoo treatment (rinse), or a hair dressing containing one or more active in- gredients. Some of the more commonly used materials have been sulfur, salicylic acid, resorcinol, coal tar, selenium sulfide, quaternary ammo- nium compounds, and hexachlorophene (1-7). * Orentreich Medical Group, 909 Fifth Ave., New York, N.Y. 10021 and New York Uni- versity School of Medicine, New York, N.Y. ?Seborrheic dermatitis: an erythemoto squamous dermatitis with a predeliction for areas with a heavy sebaceous gland population. 189

190 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS Nearly all of the published clinical studies deal with a single active preparation almost without exception, they report the tested system to be efficacious. The absence of comprehensive comparative studies does not permit firm conclusions as to the relative effectiveness of available treat- ments although certainly not all of the available treatments are equally effective! This paper presents the results obtained in a controlled clinical study with two active systems, both of which are currently being used in com- mercially available shampoos. This is the first time that comparative data on the efficacies of these two active systems on frank seborrheic der- matiris have been published. MATERIALS AND METHODS The preparations involved in the test were (A) a zinc pyrithione sham- poo • (g) a shampoo containing sulfur, salicylic acid, and hexachloro- phene * and (C) a placebo shampoo, identical to (A) except for the omis- sion of the zinc pyrithione. All three products were packed in identical 6.5-fi. oz. plastic bottles. Label instructions called for at least once-a-week use at home and gave the following instructions in product usage: "Lather-Rinse-Repeat." In ad- dition, the lable of product (B) instructed the user to leave each lather on the scalp for 5 min before rinsing. The shampoos were used by men and women, assigned in a balanced fashion to three groups on the basis of the pretest severity of their derma- titis. In that way, each group included the same percentage of subjects with various degrees of dermatitis. The grading was done visually and the entire scalp was graded on a 0-4 scale. The criteria used in evaluating seborrheic dermatitis of the scalp were as follows: 0 is no dermatitis. 1 is minimal dermatitis, subjectively not a problem to the patient, ob- jectively detectable by the examining physician. A small percentage of these patients would have glabrous skin involvement. 2 is moderate dermatitis, both subjectively and objectively detectable by the examining physician, as well as the patient. Approximately half of these patients would have glabrous skin involvement. * Head and Shoulders, The Procter & Gamble Co., Cincinnati, Ohio 45224. t Sebulex, Westwood Pharmaceuticals, Buffalo, N.Y. 14213.