J. Soc. Cosmetic Chemists, 18, 785-796 (Dee. 9, 1967) Use of Electronic Data Processing in Anti-Dandruff Clinical Research MARTIN GREIF, B.S.,* and HARRY J. PROKOP• Presented November $0, 1966, New York City Synopsis--Fifteen different compositions were studied in a pilot clinical program in terms of their ability to control the symptoms of dandruff. The clinical protocol is discussed briefly. Electronic data processing of the double-blind monadic clinical study is described in some detail. For comparison purposes, the data were analyzed both by EDP and manual means. The relative economics are discussed. INTRODUCTION The etiology of dandruff and its treatment have been discussed in scores of technical communications during the past century. In an early scientific discussion of dandruff, Malassez (1) was the first to indict Pityrosporum ovale as the cause of dandruff. Over the years from 1874 to the present day, numerous authors have taken sides for or against this hypothesis. Each has presented evidence to support his contentions. The literature is replete with references (2-8) covering both sides of this controversy. A systematic review of the literature discloses that numerous addi- tional theories on the cause of dandruff have been offered, and countless treatment procedures were reported as being effective. Thus there are theories relating to various microbial causes (9-14). Wallace (15) con- siders dandruff to be a manifestation of seborrhea or psoriasis bearing no * Consumer Products Division, American Cyanamid Company, Wayne, N.J. 07470. t Fisher-Stevens, Clifton, N.J. 07012 785

786 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS causal relationship to the microorganisms found on the scalp. He recom- mends the keratolytic approach. Van Abbe (16) suggests that an al- lergic mechanism plays a significant role in dandruff causation. Some investigators (17, 18) maintain that the condition is a disordered normal desquamating process often associated with excessive oil secretion on the scalp. Harry (3) cites several authors who attempted to show a relation- ship between digestive disorders and dandruff. Considering the many hypothetical causes of dandruff symptom- atology, it is no surprise that treatment approaches indude antimicrobial as wdl as keratolytic therapy steroid antihistaminic antimitotic special dietary and recently, enzymatic (19, 20) approaches. It is widely agreed that the first consideration in effective treatment for dan- druff requires thorough cleansing of the scalp to remove both loose and adherent scale. The second phase generally involves the use of a suit- able agent to inhibit further production of scale. It is in the latter phase where most differences of opinion arise. Some investigators employ various biochemical means to inhibit scaling. Others prefer to incorpo- rate the therapeutic agent in a shampoo, while still others apply it as a post-shampoo rinse. Another school of thought recommends a pre- shampoo treatment. This investigation was designed on the theory that topical post- shampoo rinse therapy is most easily controlled. A standard pre-treat- ment shampoo was used. The rinses were simple aqueous solutions or suspensions of different active ingredients supplemented with a condi- tioner. They were designed to place the therapeutic agents in intimate contact with the hair and scalp. Approximately 750 subjects entered and 717 completed the study. Early in the planning stages it became apparent that more than one dinical trial with basically the same design would eventually be required. Masses of data would be generated, and these would undoubtedly be cumbersome and costly to process manually. A review of the protocol suggested that with properly designed record forms the study could be programmed for electronic data processing. Once the programming costs were amortized, subsequent data processing costs and time require- ments would be rdativdy small. If the program were flexible enough, it might be adaptable to other studies with other products. This paper will briefly discuss the dinical protocol and then consider the data pro- cessing in some detail. For comparison purposes the data were analyzed by both EDP and manual means. The relative economics will also be discussed.