Prospective Study of Topical Adapinoid Versus Topical Retinol

Study Overview
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Brief Summary
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This study is to analyze and compare the effects of applying two topical vitamin-A derived ingredients on facial skin health, appearance and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate, a novel anti-aging ingredient.

Detailed Description
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We want to assess the effect of applying vitamin A-derived ingredients on facial skin health, appearance, and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate. In this study, participants will be randomized to either receiving a retinol product, or an Adapinoid product and they will be assessed at three follow up visits at week 4, week 8, and week 12.

Official Title
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Prospective, Double-Blinded, Randomized Head-to-Head Study of Topical Adapinoid Versus Topical Retinol

Conditions
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Wrinkle

Intervention / Treatment
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* Other: Retinol
* Other: Adapinoid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women between the ages of 35 years old and 65 years old Exclusion Criteria: Individuals who are pregnant or breastfeeding. Prisoners. Adults unable to consent. Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study. Subjects using any topical retinoid, acetyl zingerone, vitamin C, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment. Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin. Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Retinol<br>Product will be used once daily in the evening for 12 weeks. 1-2 pumps (size of quarter) of product will be applied on the face. | Other: Retinol<br>* Topical retinol (0.5%) applied to the face<br>|
| Experimental: Adapinoid<br>Product will be used once daily in the evening for 12 weeks. 1-2 pumps (size of quarter) of product will be applied on the face. | Other: Adapinoid<br>* Topical Adapinoid (0.5%) applied to the face<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial fine lines and wrinkles | Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial fine lines and wrinkles | Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System) | 4 weeks | 
| Facial fine lines and wrinkles | Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System) | 8 weeks | 
| Skin redness | Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System) | 4 weeks | 
| Skin redness | Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System) | 8 weeks | 
| Skin redness | Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System) | 12 weeks | 
| Facial skin pigment evenness | Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System) | 4 weeks | 
| Facial skin pigment evenness | Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System) | 8 weeks | 
| Facial skin pigment evenness | Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System) | 12 weeks | 
| Self-perception of skin health and appearance | Survey-based self-assessment of aspects of skin health and appearance | 4 weeks | 
| Self-perception of skin health and appearance | Survey-based self-assessment of aspects of skin health and appearance | 8 weeks | 
| Self-perception of skin health and appearance | Survey-based self-assessment of aspects of skin health and appearance | 12 weeks | 
| Tolerability of product | Questionnaire based self-assessment about the tolerability of the topical skin product | 4 weeks | 
| Tolerability of product | Questionnaire based self-assessment about the tolerability of the topical skin product | 8 weeks | 
| Tolerability of product | Questionnaire based self-assessment about the tolerability of the topical skin product | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-aging, skin care