A Study to Evaluate the Effect of a Topical Retinol on Ep... | NCT06658847

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.