Crepey SkinPhase 4NCT07398989
A Clinical Study to Assess Efficacy and Tolerability of a Topical Skincare Product on Adults With Mature, Crepey Skin
A Phase 4 study testing Cetaphil in people with Crepey Skin and Aging Skin, run by Galderma R&D at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Crepey Skin, Aging Skin, Photo-aged Skin
- What is being tested?
- Cetaphil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Aug 2025to 25 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
- Ability to read, understand, and give consent for participation in the study.
- Willing to sign a photography release.
- Agreement to comply with all the time commitments and adhere to the procedural requirements of the protocol, and to report to the Site on the day(s) and at the time(s) scheduled for the assessments.
Who cannot join
- 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
- Immunomodulators, including biologics - 6 months
- Non-steroidal anti-inflammatory drugs - 2 weeks 9. Having observable sunburn, suntan, scars, nevi, excessive hair, tattoos, piercings, or other dermal conditions on the test areas that might interfere with the trial results in the opinion of the Investigator. 10. Planning intense UV exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.). 11. Having clinically significant abnormality according to the Investigator during enrollment. 12. Having any disease that might interfere with the trial results in the opinion of the Investigator. 13. Current smokers of tobacco products. 14. Unwilling to refrain from use of prohibited medication during the clinical trial. 15. Other condition preventing the subject from entering the study in the Investigator's opinion, (e.g., subjects failing baseline assessments, subjects not likely to avoid other cosmetic treatments in the treatment area, subjects anticipated to be unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result). 16. The subject is currently participating in any other clinical trial of a drug or device OR past participation in any other clinical trial within the 30 days prior of Screening. 17. Study site personnel, close relatives of the study site personnel (e.g., parents, children, siblings, or spouse), or employees and close relatives of employees at the Sponsor company.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Ablon Skin Institute & Research Center
Manhattan Beach, California, 90266
About this study
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
- Being tested
- Cetaphil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetaphilDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Skincare Product Treatment | Experimental | Subjects will apply topical skincare products to the body. Receives: Drug: Cetaphil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start12 Aug 2025
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crepey SkinStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398989
- Sponsor's protocol ID
- GLI.04.US.SL.048
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess Efficacy and Tolerability of a Topical Skincare Product on Adults With Mature, Crepey Skin
- ClinicalTrials.gov ID
- NCT07398989
- Acronym / sponsor ID
- GLI.04.US.SL.048
- Conditions
- Crepey Skin, Aging Skin, Photo-aged Skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skincare Product Treatment | Experimental | Drug: CetaphilSubjects will apply topical skincare products to the body. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (17 listed)
- 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:
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Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetaphilSubjects 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. | Drug | Skincare Product Treatment |
Primary outcome
Change of clinical grading compared to baseline
Time frame: Baseline, Week 4, Week 8, Week 12
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.
Change in skin hydration as measured by Corneometer
Time frame: Baseline, Week 4, Week 8, Week 12
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.
Change in tolerability grading compared to baseline
Time frame: Baseline, Week 4, Week 8, Week 12
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.
Change in skin quality measured by macroscopic imaging (Visioscan)
Time frame: Baseline, Week 4, Week 8, Week 12
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.
Measured pH values consistent with baseline
Time frame: Baseline, Week 4, Week 8, Week 12
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cetaphil in people with Crepey Skin and Aging Skin, run by Galderma R&D at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of clinical grading compared to baseline (time frame: Baseline, Week 4, Week 8, Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.