A Clinical Study to Assess Efficacy and Tolerability of a Topical Skincare Product on Adults With Mature, Crepey Skin

NCT07398989 | Completed Phase 4 FDA Drug

• 1 other identifier: GLI.04.US.SL.048
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Crepey Skin; Aging Skin; Photo-aged Skin

Outcome Measures

Primary Outcomes (5)

• Change of clinical grading compared to baseline

  Clinical grading of efficacy parameters will be performed at both study sites. The efficacy parameters will be assessed by the Investigators at the knees and lower thighs using a modified Griffiths' 10-point scale , with 0 indicating best possible condition and 9 indicating worst possible condition. Half-point scores may be used as necessary to more accurately describe the skin condition. A decrease in scores indicates an improvement.

  Baseline, Week 4, Week 8, Week 12

• Change in skin hydration as measured by Corneometer

  Corneometer (Courage + Khazaka, Germany) measurements will be taken in triplicate to assess skin hydration. The Corneometer measures in Corneometer units from 0 (no water at all) - 120 (on water). Measurements will be taken on the lower thigh/upper knee at 9 locations. An increase in scores indicates an improvement.

  Baseline, Week 4, Week 8, Week 12

• Change in tolerability grading compared to baseline

  Tolerability assessment will be evaluated at both study sites. The areas for evaluation on the body are knees and lower thighs. Investigator will assess erythema, edema, and dryness using a 4-point analog scale (with half-point scores used as necessary to better describe the clinical condition). A score of 0 indicates best possible condition, and a score of 3 indicates worst possible condition.

  Baseline, Week 4, Week 8, Week 12

• Change in skin quality measured by macroscopic imaging (Visioscan)

  Macroscopic imaging procedure of skin texture will be performed using Visioscan® VC 20plus on all subjects, at Site 1 only. Images will be taken of each subject's upper knee (left or right). Imaging location will be the same at each timepoint.

  Baseline, Week 4, Week 8, Week 12

• Measured pH values consistent with baseline

  Skin pH measurements will be performed using pH Meter on all subjects, at Site 1 only. Triplicate measurements will be taken on the upper knee (left or right). pH value will be expressed in two decimals. A lack of significant change in values indicates maintenance of skin pH.

  Baseline, Week 4, Week 8, Week 12

Other Outcomes (2)

• Visual change in bruising intensity compared to baseline

  Baseline, Week 12

• Change in bruising duration compared to baseline bruise induction

  Baseline, Week 12

Study Arms (1)

Skincare Product Treatment

EXPERIMENTAL

Subjects will apply topical skincare products to the body.

Drug: Cetaphil

Interventions

Cetaphil DRUG

Subjects will apply Cetaphil Hydrating and Firming Cream Skin Activator to the knees, thighs, hands, and all of the body at least twice daily. Subjects will use Cetaphil Daily Facial Moisturizer SPF 35 as needed.

Skincare Product Treatment

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Willing to stop using current topical skincare products for the duration of the study.
• Willing to replace current skincare products with study product for the duration of the study.
• Willing to have investigational areas photographed, i.e., knees, lower thighs, hands.
• Willing to change into clinic-provided clothes for study photography of the knees/lower thighs.
• For biopsy subgroup (n = 5) at Site 1: having healthy immune system, willing to have skin biopsies on the upper knees
• For all subjects at Site 2: willing to undergo bruise induction procedure on the upper knees
• For female subjects of childbearing potential, she must not be pregnant, breastfeeding or planning pregnancy during the course of the study. Subjects must be willing to take a urine pregnancy test (UPT) prior to study start. Females of non-childbearing potential, e.g., post-menopausal, hysterectomy, or bilateral ovariectomy, are not required to have a UPT.

You may not qualify if:

• Pregnant, breastfeeding, or planning pregnancy during the course of the study. 2. Subject with any known allergies or hypersensitivity to any cosmetics, personal care products, and/or fragrances. 3. History of cancer within the past 5 years 4. History or presence of any skin condition/dermatologic disease on the test areas (knees, lower thighs, hands) that might interfere with the evaluation of study parameters and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part to the trial. 5. Planning on having surgeries and/or invasive medical procedures during the course of the study. 6. For biopsy subgroup at Site 1 and all subjects at Site 2:
• 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.
• 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:
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• Oral isotretinoin (Accutane) or other oral retinoids - 6 months.
• Avita, Differin, Renova, Retin-A, Retin-A Micro, Soriatane, or Tazorac - 3 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.
• Over-the-counter (OTC) retinol-containing products (with retinaldehyde, retinyl palmitate, retinyl esters, retinyl acetate, or retinyl propionate, etc.) - 4 weeks.
• Other OTC anti-wrinkle, skin-lightening, or other product or topical or systemic products known to affect skin aging or dyschromia (eg, products containing alpha/beta/poly-hydroxy acids, emblica extract, Gigawhite, hydroquinone, lemon juice extract \[topically\], Q-10, soy, systemic or licorice extract \[topically\], Tego® Cosmo C250, vitamin C\[topically\]) - 2 weeks.
• Antibiotics (except penicillin) - 4 weeks
• Benzoyl peroxide, azelaic acid, zinc, corticosteroids, other topical treatments (including laser) - 2 weeks
• Corticosteroids (except inhaled corticosteroids or intrathecal corticosteroids) - 4 weeks

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (2)

Ablon Skin Institute & Research Center

Manhattan Beach, California, 90266, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

MeSH Terms

Interventions

cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 10, 2026
• Study Start: August 12, 2025
• Primary Completion: March 25, 2026
• Study Completion: March 25, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)