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Clinical Trials/NCT05778760
NCT05778760CompletedNot Applicable

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

Integrative Skin Science and Research2 sites in 1 country48 target enrollmentStarted: May 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
48
Locations
2
Primary Endpoint
Facial fine lines and wrinkles

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
35 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Facial fine lines and wrinkles

Time Frame: 12 weeks

Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)

Secondary Outcomes

  • Facial fine lines and wrinkles(8 weeks)
  • Skin redness(12 weeks)
  • Facial skin pigment evenness(12 weeks)
  • Self-perception of skin health and appearance(12 weeks)
  • Tolerability of product(12 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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