Prospective Study of Topical Adapinoid Versus Topical Retinol

Not Applicable

Completed

• Conditions: Wrinkle
• Interventions: Other: Retinol; Other: Adapinoid

• Registration Number: NCT05778760
• Lead Sponsor: Integrative Skin Science and Research

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 Timeline

• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-21
• Study Start: 2023-05-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-15
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retinol	Retinol	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.
Adapinoid	Adapinoid	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.

Primary Outcome Measures

Name	Time	Method
Facial fine lines and wrinkles	12 weeks	Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States