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

NCT06658847 | Completed

• 1 other identifier: CS2024SK100183
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinoid; Skin Aging; Epigenomics

Keywords

Retinoid; Skin Aging

Outcome Measures

Primary Outcomes (1)

• Skin tape stripping.

  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)

Study Arms (2)

Intervention Cell

EXPERIMENTAL

Investigational Night Cream plus auxiliary cleanser and sunscreen

Other: Night Cream Usage

No Intervention

ACTIVE COMPARATOR

Auxiliary cleanser and sunscreen only

Other: No Night Cream Usage

Interventions

Night Cream Usage 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.

Intervention Cell

No Night Cream Usage 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.

No Intervention

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Has known allergies or negative reactions to common topical skincare products, adhesives, latex, or ingredients in the study products.
• Has clinically active bacterial, fungi, or viral skin infection or has frequent skin infections.
• 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).
• Has self-perceived sensitive skin.
• Is a regular (occasional to daily) smoker of cigarettes or user of electronic cigarettes (vaping pens).
• Is a regular (occasional or frequent) user of tanning beds and/or self-tanning products.
• 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).
• Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti- diabetic medication.
• Is taking a medication that could mask a negative reaction or influence study results, as determined by the PI.
• Is self-reported to be breastfeeding, pregnant or planning to become pregnant during the study.
• 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.
• Is currently participating in any other clinical study or has participated in any product-use study within 30 days prior to the study visit.
• Is an employee/contractor or immediate family member of the PI, study site, or Sponsor.

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 26, 2024
• Study Start: November 7, 2024
• Primary Completion: April 29, 2025
• Study Completion: April 29, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)