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

Galderma R&D2 个研究点分布在 1 个国家目标入组 32 人开始时间: 2025年8月12日最近更新: 2026年4月15日

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Galderma R&D
入组人数: 32
试验地点: 2
主要终点: Change of clinical grading compared to baseline

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 40 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•Pregnant, breastfeeding, or planning pregnancy during the course of the study.
•Subject with any known allergies or hypersensitivity to any cosmetics, personal care products, and/or fragrances.
•History of cancer within the past 5 years
•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.
•Planning on having surgeries and/or invasive medical procedures during the course of the study.
•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
•Having clinically active bacterial, fungal, or viral skin infections or those who have a history of skin infections.
•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.
•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
•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.
•Planning intense UV exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.).
•Having clinically significant abnormality according to the Investigator during enrollment.
•Having any disease that might interfere with the trial results in the opinion of the Investigator.
•Current smokers of tobacco products.
•Unwilling to refrain from use of prohibited medication during the clinical trial.
•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).
•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.
•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.

研究组 & 干预措施

Skincare Product Treatment

Experimental

Subjects will apply topical skincare products to the body.

干预措施: Cetaphil (Drug)