A Study to Evaluate the Effect of a Topical Retinol on Epigenetic Changes and Expression of Certain Genes in the Skin Using Non-invasive Measurements

NCT ID: NCT06658847

Last Updated: 2025-06-17

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-07

Study Completion Date

2025-04-29

Brief Summary

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This study is being conducted to confirm whether skin tape stripping methodology can identify changes in gene expression (i.e. whether different genes are turned on to make proteins) in aged skin after use of a retinoid.

Detailed Description

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This is a randomized study. Participants will be randomly assigned to either the intervention cell and receive a cleanser, a sunscreen serum, and a night cream or the control cell and receive a cleanser and a sunscreen serum to use at home for 10 weeks. Participants will be randomized and receive products at Visit 1 (Screening/Baseline) conducted at Day 0 and return to the clinical site at Day 28 for Visit 2, and at Day 71 for Visit 3.

Conditions

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Retinoid Skin Aging Epigenomics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention Cell

Investigational Night Cream plus auxiliary cleanser and sunscreen

Group Type EXPERIMENTAL

Night Cream Usage

Intervention Type OTHER

Participants will use the provided products only on their face and right upper inner arm. The auxiliary cleanser will be used twice per day (morning and evening). The auxiliary sunscreen will be used 15 minutes prior to sun exposure and reapplied after 80 minutes of sweating or swimming. The investigational night cream will be used daily in the evening/at night.

No Intervention

Auxiliary cleanser and sunscreen only

Group Type ACTIVE_COMPARATOR

No Night Cream Usage

Intervention Type OTHER

Participants will use the provided products only on their face and right upper inner arm. The auxiliary cleanser will be used twice per day (morning and evening). The auxiliary sunscreen will be used 15 minutes prior to sun exposure and reapplied after 80 minutes of sweating or swimming. No night cream will be used.

Interventions

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Night Cream Usage

Participants will use the provided products only on their face and right upper inner arm. The auxiliary cleanser will be used twice per day (morning and evening). The auxiliary sunscreen will be used 15 minutes prior to sun exposure and reapplied after 80 minutes of sweating or swimming. The investigational night cream will be used daily in the evening/at night.

Intervention Type OTHER

No Night Cream Usage

Participants will use the provided products only on their face and right upper inner arm. The auxiliary cleanser will be used twice per day (morning and evening). The auxiliary sunscreen will be used 15 minutes prior to sun exposure and reapplied after 80 minutes of sweating or swimming. No night cream will be used.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Has clinically determined moderate photodamage (defined as a score of 4 - 6 on a 0- 9-point scale) on the face at Visit 1.
2. Is able to read, write, speak, and understand English.
3. Generally in good health.
4. Intends to complete the study and is willing and able to follow all study instructions.

Exclusion Criteria

1. Has known allergies or negative reactions to common topical skincare products, adhesives, latex, or ingredients in the study products.
2. Has clinically active bacterial, fungi, or viral skin infection or has frequent skin infections.
3. Presents with a skin condition that may increase risk to the subject, influence study results, or interfere with study evaluations (e.g. acne, psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, active skin cancer, tattoos, scarring, scratches/broken skin, sunburn, excessive hair growth, or very uneven skin tone) as determined by the principal investigator (PI).
4. Has self-perceived sensitive skin.
5. Is a regular (occasional to daily) smoker of cigarettes or user of electronic cigarettes (vaping pens).
6. Is a regular (occasional or frequent) user of tanning beds and/or self-tanning products.
7. Has had a surgical or aesthetic procedure in the last 3 months that can affect facial wrinkles or facial pigmentation (e.g. botulinum toxin (Botox) injections, chemical peels, laser-based therapies to the face, or face lift surgery).
8. Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti- diabetic medication.
9. Is taking a medication that could mask a negative reaction or influence study results, as determined by the PI.
10. Is self-reported to be breastfeeding, pregnant or planning to become pregnant during the study.
11. Has a history of or a current health/other condition/situation which may put the individual at significant risk, influence the study results, or interfere significantly with the individual's participation in the study.
12. Is currently participating in any other clinical study or has participated in any product-use study within 30 days prior to the study visit.
13. Is an employee/contractor or immediate family member of the PI, study site, or Sponsor.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Consumer Inc. (J&JCI)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dermatology Consulting Services, PLLC

High Point, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CS2024SK100183

Identifier Type: -

Identifier Source: org_study_id

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