I. Soc. Cosmet. Chem., 25, 73-91 (February 1974) Appraisal of Efficacy of Antidandruff Formulations ALBERT M. KLIGMAN, M.D., Ph.D., RICHARD R. MARPLES, B.M., M.Sc., M.R.C. Pathol., LARRY R. LANTIS, M.D.,* and KENNETH J. McGINLEY* Synopsis-The EFFECTIVENESS of ANTIDANDRUFF SHAMPOOS and grooming agents can be reliably assessed in a month's time on groups as small as 10 persons. The important prerequisites are that the subjects have at least moderately severe dandruff and that estimations be made at a fixed interval after washing the scalp. Two modes of EVALUATION are utilized: (a) a subjective one in which the amount of scaling is scored on a 0 to 10 scale, and (b) an objective one in which the quantity of horny cells produced is measured in a hemocytometer. Data are given for two widely used efficacious shampoos and for a nonmedicated control. These are valuable benchmarks which enable products to be compared on a scale of comparative merit. INTRODUCTION Medically, dandruff is a trivial condition socially, it is a formidable problem for millions spend millions for alleviation. The disperser of scales has become odious. Numerous products greet the seeker of relief from scaling. These comprise a spectrum from the worthy to the worthless. The sale of ineffective products does not necessarily reflect meretriciousness on the part of merchandisers. No shampoo can be completely ineffective merely washing the scalp fre- quently enough will keep the surface scoured. Many persons obsessively con- cerned with cleanliness will mistake slight physiologic scaling for disease merely washing once or twice weekly •vill satisfy these pseudodandruff sub- jects. The chief reason why good and bad products are blurred in the market place is the absence of a reliable methodology for appraising effectiveness. Procedures need to be standardized and above all the magnitude of the effects quantified. *Postdoctoral Trainee, USPHS Grant TI AM 05261. ?Department of Dermatology, School of Medicine, University of Pennsylvania, Phila- delphia, Pa. Reprint requests should be addressed to Dr. Kligman. 73

74 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS Others have preceded us in the search for quantification. Weighing the scales removed by brushing or by vacuuming has been proposed (1, 2). In our hands, these methods lack reproducibility. Furthermore, they sample only a proportion of the scales present the Botwinicks found a low correlation with clinical severity (3). This inherent variability becomes extreme at the poles of high or low scaling. Gross visualization is most often employed .(4-6). The reliability of the results strongly depends on the rules by which the test is conducted, especially the criteria by which subiects are selected. It should not surprise anyone therefore that different observers disagree about the very same products. Though in vitro screening for antimicrobial activity has its adherents, particularly for selecting potentially effective compounds, the final verdict rests with clinical performance (7). We have been studying the nature of dandruff for the past 6 years. Though many aspects are still very puzzling, enough has been learned to establish standard techniques for appraising effectiveness. The description of these procedures and the observations on which they are grounded are presented in this paper. EXPERIMENTAL STUDIES AND i•ESULTS Methods The subjects selected were young male prisoner volunteers, mainly black. No differences were discerned between the races. Clincal Grading Dandruff was graded on a scale of 0 to 10 by one observer. As with tea tasters, perfume sniffers, and other specialists, a dandruff connoisseur is in- dispensable for this work. The first examination was 4 days after a bland shampoo. The scalp was scraped with a wooden tongue depressor at multiple points and an overall grade was given. Free scales in the hair were ignored. Depending on the amount of scurf thus scratched up, su'bjects were scored as follows: 0-1, very little scaling 2-3, mild scaling 4-5, moderate scaling 6-7, severe scaling 8-10, very severe scaling. In practice, a score of 0 or i is never given prior to treatment, but may be achieved after highly effective treatment. Likewise, scores of 9-10 are never assigned initially. These are included to take into account the full range of potential manifestations for example, when heavy dandruff subjects are prevented from washing for 2 weeks, scaling becomes spectacular. In our scheme, a grade of 5 designates moderately severe dandruff easily ascertainable by even the neophyte ob- server. Grade 6 is severe dandruff higher grades are rarely encountered in the general population. A score of 4 signifies mild dandruff. Below this level clinical grading becomes quite unreliable these subjects do not have dan- druff. Only the expert can make appraisals in the 0 to 3 range, and not very accurately at that.