Overall Effectiveness of a Potentiatied 2% Micronized Platelet Pyrithione

1. Overall Effectiveness of a Potentiatied 2% Micronized Platelet Pyrithione Zinc Shampoo Among Severe Dandruff/Seborrheic Dermatitis Sufferers HL Rocchetta, PhD, JR Schwartz, PhD, T Darcy, PhD, J Erb, K Grau, J Thomas, PhD, J Morgan, F Luo, PhD, M Copas The Procter & Gamble Company, Cincinnati, OH CONCLUSIONS RESULTS OBJECTIVE INTRODUCTION Dandruff/seborrheic dermatitis of the scalp is characterized by flaking, irritation, itch, redness, and dryness. These conditions can be more severe when symptoms are heightened, more persistent, and/or do not respond to treatment. Previously we reported efficacy of micronized platelet PTZ can be potentiated in a shampoo with cosmetic excipients such as zinc carbonate to improve bioavailability of PTZ1. Here, we report the effectiveness of a potentiated, 2% ZPT shampoo which provides strong symptom relief against a range of symptom severity (i.e., moderate to severe) and is effective at reducing Malassezia. • Clinical Studies • Pairwise comparisons of self assessed symptoms demonstrate that severe sufferers (based on ASFS), are statistically different (p≤0.05) than moderate and mild sufferers (Table 1). • The potentiated 2% ZPT shampoo • provided ASFS reductions to 90.1% of moderate and severe sufferers and 94.4% of severe sufferers (Table 2). • Consumer Study • Following 2 weeks of consumer usage, the • potentiated 2% ZPT shampoo reduced • dandruff symptoms reported to be ‘moderate • to more than moderate’ from 50% to 11%. • The potentiated 2% micronized PTZ shampoo is effective at reducing dandruff/seborrheic dermatitis symptoms (i.e., flaking, itch and dryness) across a range of severities (moderate to severe). • In vitro and in vivo testing support the effectiveness of the potentiated 2% micronized PTZ shampoo at reducing Malassezia, the most effectively treated cause of dandruff/seborrheic dermatitis. Reference • 1J. R. Schwartz, Product pharmacology and medical actives in achieving therapeutic benefits. J. Invest. Dermatol. Symp. Proc., 2005. 10: p. 198-200 The primary objective of this work was to assess the overall effectiveness of a potentiated 2% micronized platelet PTZ shampoo among severe dandruff/seborrheic dermatitis sufferers. • Table 3. Reduction in Dandruff Severity Following a Consumer Use Study. Table 1. Mean Self Assessed Symptoms by ASFS Severity (Study A) • In Vitro & In Vivo Antifungal Tests • In vitro and in vivo testing show potentiated 2% ZPT shampoo to be effective against Malassezia (Table 4). METHODS Clinical Studies Study A – 500 subjects participated in a dandruff/seborrheic dermatitis prevalence study. Endpoints – dermatologist graded Adherent Scalp Flaking Scores (ASFS) and self assessed symptom severity. Study B – 97 subjects participated in a 3 week, double-blinded, parallel design, placebo controlled, randomized clinical study. Subjects refrained from using any dandruff products 2 weeks prior to the treatment period (shampoo usage - at least 3X/week). Endpoints - dermatologist graded ASFS and self assessed symptom severity. • Table 4. In Vitro and In VivoMalassezia reductions. • Consumer Study • 208 subjects participated in a single product, 2 week consumer test with self reported dandruff/seborrheic dermatitis symptoms. Post-usage consumers reported how well the product controlled symptoms. • In Vitro and In Vivo AntifungalTesting • In Vitro - Solution-based and zone of inhibition assays (ZOI) whereby product dilutions are tested for anti-Malassezia activity. • In Vivo – Two week consumer usage test (shampoo usage 3X/week) whereby scalp swabs are taken, slides prepared/stained and Malassezia enumerated by fluorescent microscopy. • * Mean of 9 historical studies • Table 2. ASFS Response to the Potentiated 2% ZPT Shampoo (Study B). • * LS Mean Change in ASFS from baseline at week 3 This work was funded by P&G Beauty