Prospective Study of Topical Adapinoid Versus Topical Retinol

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

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.

Study Overview

• Status: Completed
• Conditions: Wrinkle
• Intervention / Treatment: Other: Retinol; Other: Adapinoid

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Retinol; Topical retinol (0.5%) applied to the face
Experimental: 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.	Other: Adapinoid; Topical Adapinoid (0.5%) applied to the face

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Actera (Sponsor)
• Investigators: Principal Investigator: Raja Sivamani, MD, Integrative Skin Science and Research

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 15, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: anti-aging; skin care
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: ADAP_RET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No