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CompletedNCT06658847Updated Jun 17, 2025

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

An interventional study of Night Cream Usage and No Night Cream Usage in Retinoid, Skin Aging and Epigenomics, sponsored by Johnson & Johnson Consumer Inc. (J&JCI). Completed at 1 site in United States. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by Johnson & Johnson Consumer Inc. (J&JCI) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
Female
01

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.

Read the 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.

02

Conditions studied

  • Retinoid
  • Skin Aging
  • Epigenomics

Keywords

  • Retinoid
  • Skin Aging
03

In context

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI) is the lead sponsor of 52 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Intervention Cell

    Investigational Night Cream plus auxiliary cleanser and sunscreen

    Other: Night Cream Usage

  • Active comparator
    No Intervention

    Auxiliary cleanser and sunscreen only

    Other: No Night Cream Usage

Interventions

  • OtherNight 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.

  • OtherNo 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.

06

What researchers measure

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.

    Time frame: Baseline (Day 0), Visit 3 (Day 71)

07

Study locations

1 site
  • Dermatology Consulting Services, PLLC
    High Point, North Carolina 27262, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06658847
Lead sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
Responsible party
Sponsor
First posted
Oct 26, 2024
Start date
Nov 7, 2024
Primary completion
Apr 29, 2025
Completion
Apr 29, 2025
Last update
Jun 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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