POWER OF PROTOCOL: CLINICAL STUDIES SHOW COSMETIC REGIMENS ARE MORE POWERFUL THAN SINGLE PRODUCTS

P1072 Cheri Swanson, Joseph Kaczvinsky, Jim Li, Patricia Raleigh, and Dennis Kuhlman The Procter & Gamble Company, Cincinnati, Ohio, USA

Introduction
Fundamental skincare has been described as a multiple-step routine, involving four essential steps: 1) Cleanse 2) Treat 3) Moisturize 4) Protect Recent studies have elevated our understanding and confirmed the benefits of targeted, regimen-based skincare by evaluating the use of a single product versus a regimen across a wide range of skin concerns.

Objectives
Four individual clinical studies were performed with endpoints specific to their cosmetic benefit. Each study evaluated a 4-product regimen designed to target a specific skin concern. Key technologies in each skin concern regimen are listed below.

SKIN CONCERN

Restorative Anti-aging

Preventative Anti-aging

Sensitive Skin

Hyperpigmentation

TARGETED TECHNOLOGY

Niacinamide Niacinamide Vitamins A, C, & E Turmeric Palmitoyl Grape seed extract pentapeptide-4 extract Palmitoyl Glycerin Glycerin pentapeptide-4 Vitamins B5 & E Glycerin

Niacinamide N-acetyl glucosamine Undecylenoyl phenylalanine Glycerin

Methods
General Clinical Study Design: Four individual double-blind, randomized, 5 to 9 week clinical studies Each study was designed to target a specific skin concern; Restorative Anti-Aging, Preventative Anti-Aging, Sensitive Skin, or Hyperpigmentation Subjects were recruited with mild to moderate levels of the appropriate skin conditions. Standard clinical methods including imaging, expert grader analysis, corneometer, and vapometer were utilized to assess fine lines and wrinkles, hyperpigmented spots, TEWL, hydration, facial blotchiness, radiance, and overall skin feel. Percent responders were calculated using standard statistical methods for each benefit. Restorative AntiAging January-April in Ohio, USA 186 Caucasian females, age 40-65 9 week facial study: 1 week of washout followed with 8 weeks of product application Preventative AntiAging February-March in Ohio, USA 40 Caucasian females, age 18-65 35 day study: 7 days of pretreatment, 22 days of product application, and 6 days regression Sensitive Skin January-March in New Jersey, USA 160 Caucasian females, age 35-65 7 week study: 1 week of washout followed with 6 weeks of product application Hyperpigmentati on February-April in Beijing, China 250 Chinese females, age 25-55 9 week facial study: 1 week of washout followed with 8 weeks of product application

Application Procedure
Treatment Group
Cleanser + Single Moisturizer Product Morning protocol
General Cleanser Targeted Daytime Moisturizer SPF 15

4-Product Targeted Regimen

CLEANSE-TREAT-MOISTURIZE-PROTECT

CLEANSE-TREAT-PROTECT

Targeted Cleanser Targeted Treatment Product Targeted Daytime Moisturizer SPF 15

CLEANSE-TREAT-MOISTURIZE

Evening protocol

General Cleanser

Targeted Cleanser Targeted Treatment Product Targeted Nighttime Moisturizer

Key Results: Restorative Anti-Aging

Restorative Anti-Aging Clinical Study Endpoints
100 90 80

Percent Responders

70 60 50 40 30 20 10 0

After 4 weeks, using a fourproduct regimen resulted in incremental benefits (as measured by increase in percent responders) vs. using a cleanser and single moisturizing product: 20% more women showed improvement in the appearance of fine lines and wrinkles (expert graders)
Fine Lines & Wrinkles Wrinkle Volume TEWL

23% more women showed improvement in wrinkle volume (image analysis) 28% more women showed improvement in skin barrier (TEWL)

Single Product

Regimen

Key Results: Anti-Aging Preventative

Preventative Anti-Aging Clinical Study Endpoints
100 90 80

Percent Responders

70 60 50 40 30 20 10 0 1 week TEWL 3 weeks TEWL 24 hr Regression TEWL 24 hr Regression with insult TEWL

After 4 weeks, using a four-product regimen resulted in incremental benefits (as measured by increase in percent responders) vs. using a cleanser and single moisturizing product: 36% more women showed improvement in skin barrier after 1 week (TEWL) 19% more women showed improvement in skin barrier after 3 weeks (TEWL) 30% more women showed improvement in skin barrier 24 hours after treatment stopped (TEWL) 39% more women showed improvement in skin barrier after physical insult 24 hours after treatment stopped (TEWL)

Single Product

Regimen

Key Results: Sensitive Skin

Sensitive Skin Clinical Study Endpoints
100 90 80 70 60 50 40 30 20 10 0

Percent Responders

After 4 weeks, using a four-product regimen resulted in incremental benefits (as measured by increase in percent responders) vs. using a cleanser and single moisturizing product: 10% more women saw improvement in facial skin radiance (subject evaluation) 21% more women saw improvement in facial skin blotchiness (subject evaluation) 17% more women saw improvement in overall skin feel (subject evaluation) 13% more women showed improvement in skin hydration (corneometer)

Facial Skin Radiance

Facial Skin Blotchiness

Overall Skin Feel

Hydration

Single Product

Regimen

Key Results: Hyperpigmentation

Hyperpigmentation Clinical Study Endpoints 100 90 Percent Responders 80 70 60 50 40 30 20 10 0 Skin Tone Evenness Spot Area Fraction Spot Area Fraction

After 4 weeks, using a fourproduct regimen resulted in incremental benefits (as measured by increase in percent responders) vs. using a cleanser and single moisturizing product: 17% more women showed improvement in skin tone evenness (NC2) 10% more women showed improvement in Spot Area Fraction (REAL image analysis) 18% more women showed improvement in Spot Area Fraction (NC2)

Single Product

Regimen

Conclusions
Across all four clinical studies, use of a facial cleanser and single moisturizing product produced a response to treatment. Percentage of responders varied from 16% to 78% for each clinical endpoint reported. In each study, use of a 4-product, targeted skincare regimen resulted in a higher percentage of responders for each clinical endpont reported. Percent increase of responders varied from 9% to 38%. These results support the incremental benefits of using a comprehensive skincare regimen of products vs. only a cleanser and single moisturizing product.

This work was funded by P&G Beauty & Grooming