A Clinical Study to Assess Efficacy and Tolerability of a Topical Skincare Product on Adults With… (NCT07398989) | Clinical Trial Compass
CompletedPhase 4
A Clinical Study to Assess Efficacy and Tolerability of a Topical Skincare Product on Adults With Mature, Crepey Skin
United States32 participantsStarted 2025-08-12
Plain-language summary
Subjects having mild-to-moderate crepiness, photodamage, and loss of firmness will apply a topical skincare regimen to the knees, thighs, hands, and all over the body. Evaluations of the regimen's efficacy will be conducted at 4 weeks, 8 weeks, and 12 weeks post-baseline.
Who can participate
Age range40 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult subjects aged 40-60 years
✓. Females and males
✓. Any Fitzpatrick skin types (FST) I-VI, with effort to include minimum n = 2 for each category per Site
✓. Any races, with effort to include minimum 10% minority (n = 3 for both Sites) such as American Indian or Alaska Native, Eastern/Southeastern Asian, South Asians, Black or African American, Native Hawaiian or Other Pacific Islander.
✓. Any ethnicities, with effort to include minimum 10% (n = 3 for both Sites) of Hispanic, Latino, or Spanish origin.
✓. History of skin fragility and prone to bruising, i.e., dermatoporosis.
✓. Having mild-to-moderate (score 3-6 according to a modified Griffiths scale, where 0 = none and 9 = severe) score for the following parameters on the knees and lower thighs: crepiness, photodamage, firmness
✓. Subjects in general good health
Exclusion criteria
✕. History of allergy or hypersensitivity to anesthetics or lidocaine
✕. Have been diagnosed with a bleeding disorder
✕. Have experienced excessive bleeding after other medical procedures
✕. Currently taking blood-thinning medications (e.g., aspirin, aspirin-containing medications, warfarin or heparin), immunosuppressive medications or systemic steroids.
What they're measuring
1
Change of clinical grading compared to baseline
Timeframe: Baseline, Week 4, Week 8, Week 12
2
Change in skin hydration as measured by Corneometer
Timeframe: Baseline, Week 4, Week 8, Week 12
3
Change in tolerability grading compared to baseline
Timeframe: Baseline, Week 4, Week 8, Week 12
4
Change in skin quality measured by macroscopic imaging (Visioscan)
✕. History of keloid formation or hypertrophic scarring 7. Having clinically active bacterial, fungal, or viral skin infections or those who have a history of skin infections. 8. The subject has received, applied, or ingested the following treatments within the specified time frame prior to the Baseline visit:
✕. Oral isotretinoin (Accutane) or other oral retinoids - 6 months.
✕. Prescription-strength skin-lightening products for the test areas (e.g., hydroquinone, tretinoin, alpha/beta/poly-hydroxy acids, 4-hydroxyanisole alone or in combination with tretinoin, etc.) - 3 months.