Prospective Study of Topical Adapinoid Versus Topical Retinol

NCT ID: NCT05778760

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-09-01

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.

Conditions

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Wrinkle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Retinol

Intervention Type OTHER

Topical retinol (0.5%) applied to the face

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.

Group Type EXPERIMENTAL

Adapinoid

Intervention Type OTHER

Topical Adapinoid (0.5%) applied to the face

Interventions

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Retinol

Topical retinol (0.5%) applied to the face

Intervention Type OTHER

Adapinoid

Topical Adapinoid (0.5%) applied to the face

Intervention Type OTHER

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Actera (Sponsor)

UNKNOWN

Sponsor Role collaborator

Integrative Skin Science and Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raja Sivamani, MD

Role: PRINCIPAL_INVESTIGATOR

Integrative Skin Science and Research

Locations

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Integrative Skin Science and Research

Sacramento, California, United States

Site Status

Countries

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United States

References

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Nguyen N, Afzal N, Min M, Ahmad N, Afzal L, Burney W, Chambers CJ, Sivamani RK. A prospective, double-blinded, randomized head-to-head clinical trial of topical adapinoid (oleyl adapalenate) versus retinol. Skin Health Dis. 2024 Nov 4;4(6):e469. doi: 10.1002/ski2.469. eCollection 2024 Dec.

Reference Type DERIVED
PMID: 39624736 (View on PubMed)

Other Identifiers

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ADAP_RET

Identifier Type: -

Identifier Source: org_study_id

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