NCT05778760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

March 10, 2023

Last Update Submit

June 15, 2024

Conditions

Wrinkle

Keywords

anti-agingskin care

Outcome Measures

Primary Outcomes (1)

  • Facial fine lines and wrinkles

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

    12 weeks

Secondary Outcomes (14)

  • Facial fine lines and wrinkles

    4 weeks

  • Facial fine lines and wrinkles

    8 weeks

  • Skin redness

    4 weeks

  • Skin redness

    8 weeks

  • Skin redness

    12 weeks

  • +9 more secondary outcomes

Study Arms (2)

Retinol

ACTIVE COMPARATOR

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

Adapinoid

EXPERIMENTAL

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

Interventions

RetinolOTHER

Topical retinol (0.5%) applied to the face

Retinol
AdapinoidOTHER

Topical Adapinoid (0.5%) applied to the face

Adapinoid

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between the ages of 35 years old and 65 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Related Publications (1)

  • 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.

    PMID: 39624736DERIVED

MeSH Terms

Interventions

Vitamin A

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Raja Sivamani, MD

    Integrative Skin Science and Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 21, 2023

Study Start

May 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)