J. Cosmet. Sci., 60, 25–29 (January/February 2009) 25 A rapid method to clinically assess the effect of an anti-acne formulation NEELAM MUIZZUDDIN, DANIEL H. MAES, and THOMAS MAMMONE, Estee Lauder Companies, Melville, NY 11747. Accepted for publication October 21, 2008. Synopsis Historically, clinical evaluation of acne treatment has been based on direct visual assessment and the counting of lesions over a period of several weeks of treatment. However, with advancing technology there has been ever-increasing speed in the effectiveness of these treatments. To successfully assess these faster treatments, acne pathology needs to be evaluated in a shorter time frame. The object of these studies was to develop techniques to evaluate individual acne lesions in a shorter time frame and to assess speedier treatment technologies. Ten healthy volunteers with acne lesions on their upper backs were recruited for the study. Two infl amed acne lesions were selected for each treatment, along with lesions to be left untreated, on each volunteer. Each lesion was marked, photographed, and visually graded. A skin surface microscope (Scopeman) was used to visualize size and to grade the lesions by two experts every day for fi ve days. The sites were treated once a day for the course of the study. There was a remarkable reduction in the size and erythema of acne lesions after treatment with the acne for- mulation as compared to the untreated and vehicle-treated lesions. Individual lesions, both treated and un- treated, appeared resolved in 14 days. This resolution can be noticeably accelerated by topical treatments. We have developed a simple and faster clinical method to evaluate the effects of topical anti-acne technology. INTRODUCTION Acne vulgaris is one of the most common skin diseases in human beings and affects up to 90% of adolescents and young adults at some point in life. One third of these individuals may require medical treatment due to the severity of the condition. A small percentage of these patients will be left with lifelong post-acne scars. These factors contribute to acne having a major impact on the quality of life and being a major socioeconomic problem. Acne vulgaris is a multifactorial disease that has at least four distinct pathological factors. These four factors are excessive sebum production, hyperproliferation of the follicular epithelium, bacterial infection, and localized infl ammation. Each of these components of the etiology of acne is not mutually exclusive of the others. One theory of acne suggests that these components are in fact sequentially dependent. The pathological process starts with the production of excessive sebum. Sebum lipids are a complex mixture of squalene, wax esters, and triglycerides. The triglycerides can be

JOURNAL OF COSMETIC SCIENCE 26 metabolized by bacterial enzymes to glycerol and free fatty acids. Excessive sebum secretion and loosely bound corneocytes clog pores and create an anaerobic environment where anaerobic microorganisms multiply and eventually provoke infl ammatory reac- tions. Excessive sebum production has been attributed to androgen levels. Several clinical observations clearly indicate a causal role for androgens in acne. Androgens have been shown to increase the size and output of sebum of the sebaceous glands (1). Acne begins to develop with the increase in androgens during the prepubertal period. Conversely, antiandrogens have been shown to reduce sebum lipids and to alleviate acne. Acne is also characterized by improper epidermal differentiation of the lower portion of the infundibulum of the sebaceous follicle. The keratinocytes lining the infundibulum are hyperproliferative compared with normal skin. This improper epidermal differentia- tion leads to a clogged pore. This clogging of the pore creates a micro-environment favor- able for the growth of acne. The excessive lipids and improper differentiation of the keratinocytes in the follicle en- courage bacteria growth and cause a weakening of the skin barrier in this follicle. This allows the excessive bacteria to migrate into the skin and contribute to the infl ammation observed in the fi nal stages of the acne process (1,2). The primary pathogenic agent implicated in the development of infl ammatory as well as non-infl ammatory acne is Propionibacterium acnes (3). P. acnes is included in a family of anaerobic, non-spore-forming gram-positive rods. The 1960s saw the use of antibiotics to treat acne by reducing P. acnes however, in the last two decades several antibiotic-resistant strains have emerged (4,5). In addition to antibiotics, topical benzoyl peroxide and salicylic acid have consis- tently been found to be effective in reducing acne lesions (5,6). The fi nal phase of comedone formation is the infl amed lesion. The bacterial infi ltrate into the skin triggers infl ammatory mediator production and cellular infi ltrate. A variety of infl ammatory mediators have been described in the acne lesion. These include IL-1 alpha, IL-1 beta, and substance P (7). In addition, there is a reported increase in lymphocytic infi ltrate and neutrophil infi ltrate into the follicular region (8). This also contributes to the infl ammation associated with the acne lesion. Clinical assessment of the effi cacy of acne treatment has been largely based on global ex- pert assessment, lesion counts or patient assessment (7–9). These techniques have been enhanced with the use of modern photographic techniques. However, these clinical as- sessments still require the counting of lesions and the documentation of shifts in the total number of lesions to determine the effi cacy of a topical treatment. This requires many weeks of the continued use of a treatment modality to observed shifts in the total number of lesions. In order to speed the evaluation process we have developed a technique to evaluate individual lesions. MATERIALS AND METHODS The treatment regimen consisted of the following materials: a simple foam cleanser, a toner (2% salicylic acid), and an oil-in-water lotion containing benzoyl peroxide. All three products were designed to address the four components of acne: keratinization, bacteria, sebum control, and infl ammation. To address each of these issues we added the following ingredients: (a) n-acetyl glucosamine, used to accelerate desquamation (b) decanoic acid, used for its antimicrobial properties (c) saw palmetto extract, used to