Clinical trial NCT06658847: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinoid
Skin Aging
Epigenomics
Keywords: Retinoid
Skin Aging
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 66
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Skin tape stripping.
timeFrame: Baseline (Day 0), Visit 3 (Day 71)
Secondary outcomes:
Other outcomes:
Locations:
city: High Point
country: United States
facility: Dermatology Consulting Services, PLLC
state: North Carolina
Study officials:
References: