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

Galderma

Status and phase

Enrolling

Phase 4

Conditions

Aging Skin

Photo-aged Skin

Crepey Skin

Treatments

Drug: Cetaphil

Study type

Interventional

Funder types

Industry

Identifiers

NCT07398989

GLI.04.US.SL.048

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

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
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.

Exclusion criteria

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:
1. History of allergy or hypersensitivity to anesthetics or lidocaine
2. Have been diagnosed with a bleeding disorder
3. Have experienced excessive bleeding after other medical procedures
4. Currently taking blood-thinning medications (e.g., aspirin, aspirin-containing medications, warfarin or heparin), immunosuppressive medications or systemic steroids.
5. 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:

1. Oral isotretinoin (Accutane) or other oral retinoids - 6 months.
2. Avita, Differin, Renova, Retin-A, Retin-A Micro, Soriatane, or Tazorac - 3 months.
3. 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.
4. Over-the-counter (OTC) retinol-containing products (with retinaldehyde, retinyl palmitate, retinyl esters, retinyl acetate, or retinyl propionate, etc.) - 4 weeks.
5. 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.
6. Antibiotics (except penicillin) - 4 weeks
7. Benzoyl peroxide, azelaic acid, zinc, corticosteroids, other topical treatments (including laser) - 2 weeks
8. Corticosteroids (except inhaled corticosteroids or intrathecal corticosteroids) - 4 weeks
9. Immunomodulators, including biologics - 6 months
10. 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.