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Overall Effectiveness of Potentiatied Micronized Platelet

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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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