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

June 16, 2025 updated by: Johnson & Johnson Consumer Inc. (J&JCI)

A Single Center, Randomized, Evaluator Blinded Clinical Study to Evaluate the Effect of a Topical Retinol on Epigenetic Changes and Expression of Certain Genes in the Skin Using Non-invasive Measurements

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Cell
Investigational Night Cream plus auxiliary cleanser and sunscreen
Other: 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.
Active Comparator: No Intervention
Auxiliary cleanser and sunscreen only
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin tape stripping.
Time Frame: Baseline (Day 0), Visit 3 (Day 71)
The investigator will collect skin samples from subjects through a non-invasive method - tape stripping. The tape strips will be analyzed by extracting DNA collected from the epidermal skin cells then use targeted sequencing using 4M CpG sites to further analyze if certain genes (assessment of UV damage, smoking, and biological age ) are turned on or off from retinol use. Baseline samples will be compared to Day 71 samples.
Baseline (Day 0), Visit 3 (Day 71)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2024

Primary Completion (Actual)

April 29, 2025

Study Completion (Actual)

April 29, 2025

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 16, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CS2024SK100183

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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