J, Soc, Uosmetic Uhemists, 18, 161-167 (Mar. 4, 1967) Clinical Evaluation of Bacteriostatic Soap in Diaper Dermatitis- Prophylaxis* EMANUEL DUBOW, M.D., F.A.A.P.,t LEO WINTER, JR., D.D.S.,• and BRUCE E. ELLICKSON, Ph.D.õ Presented September 20-21, 1966, Seminar, New York City Synopsis--A clinical study was conducted in the New York City area using 100 infants with a history of diaper rash but who were not suffering from diaper rash at the beginning of the study. Fifty infants were bathed with an antibacterial soap containing 0.75% hexachloro- phene and 0.75 • 3,4,4 •-trichlorocarbanilide 50 infants were bathed with the same soap with- out the presence of the antibacterial agents. In the case of the relatively common varieties of diaper rash, the severity and the incidence during the use of the antibacterial soap were significantly lower than that from the soap containing no antibacterial system. INTRODUCTION Diaper dermatitis continues to be one of the most common problems of pediatrics (1). At some time it occurs in almost all infants, and cases serious enough to warrant treatment account for 25% of all pediatric patients seen (2-4). This figure does not include the milder forms of irritation noted during well-baby checkups (5). The etiology of diaper dermatitis is not entirely clear, though it is estimated that over 90% are due to contact dermatitis resulting from * Contributed by Armour Grocery Products Co., a Division of Armour and Co., Chicago, Ill. • Diplomate, American Board of Pediatrics, 7 Lexington Ave., New York, N.Y. :• Leo Winter Associates, Inc., 211 E. 43rd St., New York, N.Y. õ Armour Grocery Pro•tlct• Go., 100 S. Wacker Dr., Chicago, Ill. 161

162 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS the interaction of urea with the gram positive rod Bacillus ammonia- genes (Bacillus faecalis) (6-8). Other bacilli (coli, proteus, A erobacter, Klebsiella, Pseudomonas and Staphylococcus) have also been implicated in various forms of diaper dermatitis (2, 9). In view of the frequency of diaper dermatitis and the acute discom- fort it causes, any inexpensive, effective and simple form of prophylaxis would be a welcome addition to infant care (10). The purpose of the present paper is to evaluate clinically the pro- phylactic effects of a bacteriostatic soap.* This soap (A) contains 0.75% 2,2 •-dihydroxy-3,3 •,5,5 •,6,6 •-hexachlorodiphenylmethane ("hexachloro- phene") and 0.75% 3,4,4•-trichlorocarbanilide. It was compared with a similar soap (B) without the bacteriostatic agents, in a double blind test. The effectiveness of hexachlorophene in the clearing and prevention of diaper dermatitis has previously been noted by other investigators (7, •, •2). Since the onset of diaper dermatitis is affected by a great variety of conditions (diet, general cleanliness, use of rubber pants, weather, sex, age, and characteristics of the infant) (14), it was felt that the statistical analysis of a large number of treated and untreated cases was the only way of demonstrating the clinical effect of the soap. EXPERIMENTS AND RESULTS Clinical Material For the purpose of the study a group of 100 infants of both sexes, ranging in age from two months to 2•/5 years and having a case history of frequent episodes of diaper dermatitis, were selected. At the start of the experiment, all symptoms of diaper dermatitis were absent. All but 16 of the test subjects used diaper service washed diapers. Experimental Procedure The infants were divided into two equal groups: Soap A was sup- plied to the mothers of one, Soap B to the other. Division into groups and distribution of the coded soap was based on the use of a random number table. Neither the clinician nor the mothers were aware of the nature of the soap used. The groups were balanced as far as sex and use of the diaper service were concerned. The mothers were instructed to bathe the baby daily, being careful to cleanse the diaper area with the soap and soft cloth. Mothers were * Dial soap, a product of Armour and Co., Chicago, II1., was used.