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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 INTRODUCTION OBJECTIVE RESULTS CONCLUSIONS Dandruff/seborrheic dermatitis of the scalp Clinical Studies Consumer Study is characterized by flaking, irritation, itch, • Pairwise comparisons of self • Following 2 weeks of consumer usage, the The potentiated 2% micronized redness, and dryness. These conditions The primary objective of this work assessed symptoms demonstrate that potentiated 2% ZPT shampoo reduced PTZ shampoo is effective at can be more severe when symptoms are was to assess the overall heightened, more persistent, and/or do not effectiveness of a potentiated 2% severe sufferers (based on ASFS), are dandruff symptoms reported to be ‘moderate reducing dandruff/seborrheic respond to treatment. Previously we micronized platelet PTZ shampoo statistically different (p≤0.05) than to more than moderate’ from 50% to 11%. dermatitis symptoms (i.e., reported efficacy of micronized platelet PTZ among severe dandruff/seborrheic moderate and mild sufferers (Table 1). can be potentiated in a shampoo with Table 3. Reduction in Dandruff Severity Following a Consumer Use Study. Symptom How would you How would you p-values flaking, itch and dryness) across dermatitis sufferers. • The potentiated 2% ZPT shampoo cosmetic excipients such as zinc carbonate Descriptors describe your dandruff severity describe your dandruff severity after a range of severities (moderate to improve bioavailability of PTZ1. Here, we provided ASFS reductions to 90.1% of before you tried this 2 weeks of using this moderate and severe sufferers and product? product? to severe). report the effectiveness of a potentiated, Extremely Slight 50% 89% p≤0.05 to Slight 2% ZPT shampoo which provides strong 94.4% of severe sufferers (Table 2). Moderate to More 50% 11% p≤0.05 symptom relief against a range of symptom Table 1. Mean Self Assessed Symptoms by ASFS Severity than Moderate In vitro and in vivo testing severity (i.e., moderate to severe) and is (Study A) support the effectiveness of the effective at reducing Malassezia. Self Assessment In Vitro & In Vivo Antifungal Tests Dandruff/ Symptom Severity of Severity of Severity of • In vitro and in vivo testing show potentiated 2% micronized PTZ METHODS Seborrheic Descriptors Flaking Scalp Itch Dry Scalp Dermatitis Mild Never Experienced 67.8% 36.9% 40.7% potentiated 2% ZPT shampoo to be shampoo at reducing (ASFS 16-24) Very Slight to Slight Moderate 26.3% 5.9% 43.4% 14.8% 46.6% 11.9% effective against Malassezia (Table 4). Malassezia, the most effectively Clinical Studies Consumer Study Somewhat Severe to Severe 0% 4.9% 0.85% Table 4. In Vitro and In Vivo Malassezia reductions. treated cause of Study A – 500 subjects participated in a 208 subjects participated in a single product, 2 Moderate Never Experienced 42.8% 19.3% 21.4% Antifungal Assays dandruff/seborrheic dermatitis. (ASFS 25-34) dandruff/seborrheic dermatitis prevalence week consumer test with self reported Very Slight to Slight 38.5% 50% 51.7% In Vitro/In Vivo Test Potentiated 2% ZPT Placebo Shampoo Moderate 15.2% 24% 22.8% study. Endpoints – dermatologist graded dandruff/seborrheic dermatitis symptoms. Somewhat Severe 3.5% 6.7% 4.2% Solution-Based Growth Shampoo 0.978 ppm >31.3 ppm Adherent Scalp Flaking Scores (ASFS) Post-usage consumers reported how well the Severe to Severe Never Experienced 22.6% 11.6% 10.8% Inhibition Reference ZOI (1:10 dilution) 30.47 mm 0 mm 1J. R. Schwartz, Product pharmacology and self assessed symptom severity. product controlled symptoms. (ASFS 35-80) Very Slight to Slight 49.5% 50.5% 46.2% Mean In Vivo Log -1.28 -0.053* Moderate 17.2% 15.8% 21.5% Malassezia reduction from (n=20) (n=14) and medical actives in achieving Study B – 97 subjects participated in a 3 In Vitro and In Vivo Antifungal Testing Somewhat Severe 10.7% 22.1% 21.6% baseline at week 2 therapeutic benefits. J. Invest. Dermatol. to Severe * Mean of 9 historical studies week, double-blinded, parallel design, In Vitro - Solution-based and zone of inhibition Symp. Proc., 2005. 10: p. 198-200 Table 2. ASFS Response to the Potentiated 2% ZPT Shampoo (Study B). placebo controlled, randomized clinical assays (ZOI) whereby product dilutions are Percent of Subjects that Experienced ASFS Reductions from Baseline at Week 3 study. Subjects refrained from using any tested for anti-Malassezia activity. Dandruff/ Potentiated 2% ZPT Shampoo (n=71) Placebo Shampoo (n=25) p-values dandruff products 2 weeks prior to the In Vivo – Two week consumer usage test Seborrheic Dermatitis Moderate & Severe (ASFS ≥ 24) 90.1% (n=64) 64% (n=16) (Potentiated 2% ZPT vs. Placebo) p=0.0026 treatment period (shampoo usage - at least (shampoo usage 3X/week) whereby scalp -19.9 ASFS units* -3.3 ASFS units* p<0.0001 3X/week). Endpoints - dermatologist graded swabs are taken, slides prepared/stained Severe (ASFS ≥ 34) 94.4% (n=34) -24.3 ASFS units* 78.6% (n=11) -8.6 ASFS units* p=0.0875 p<0.0001 ASFS and self assessed symptom severity. and Malassezia enumerated by fluorescent * LS Mean Change in ASFS from baseline at week 3 This work was funded by P&G Beauty microscopy.
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