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

Last updated: June 16, 2025
Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
Overall Status: Completed

Phase

N/A

Condition

Skin Aging

Treatment

No Night Cream Usage

Night Cream Usage

Clinical Study ID

NCT06658847
CS2024SK100183
  • Ages 40-65
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 studyinstructions.

Exclusion

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 skininfections.

  3. Presents with a skin condition that may increase risk to the subject, influencestudy 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 skintone) 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 electroniccigarettes (vaping pens).

  6. Is a regular (occasional or frequent) user of tanning beds and/or self-tanningproducts.

  7. Has had a surgical or aesthetic procedure in the last 3 months that can affectfacial 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 studyresults, as determined by the PI.

  10. Is self-reported to be breastfeeding, pregnant or planning to become pregnant duringthe study.

  11. Has a history of or a current health/other condition/situation which may put theindividual at significant risk, influence the study results, or interferesignificantly with the individual's participation in the study.

  12. Is currently participating in any other clinical study or has participated in anyproduct-use study within 30 days prior to the study visit.

  13. Is an employee/contractor or immediate family member of the PI, study site, orSponsor.

Study Design

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: No Night Cream Usage
Phase:
Study Start date:
November 07, 2024
Estimated Completion Date:
April 29, 2025

Study 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.

Connect with a study center

  • Dermatology Consulting Services, PLLC

    High Point, North Carolina 27262
    United States

    Site Not Available

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