Clinical Trial: Combined use of Test Product 1 or Test Product 2 versus single topical use for effect on the surface area of the stratum corneum in healthy women (Japan)

Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057215) titled 'Combined use of Test Product 1 or Test Product 2 versus single topical use for effect on the surface area of the stratum corneum in healthy women' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Otsuka Pharmaceutical Co., Ltd.

Condition: Condition - Healthy adult female Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of single and combined use of Test Product 1 and Test Product 2 on the surface area of stratum corneum cells in healthy women. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - The test product, which is dispensed with two pushes, was applied topically twice a day for 8 weeks. Interventions/Control_2 - non-appplication area

Eligibility: Age-lower limit - 50 years-old

Gender - Female Key inclusion criteria - - Healthy adult females between the ages of 50 and 80 years old. - Subjects will be divided into three age groups (50-59, 60-69, and 70-79 years old), and the first 30 subjects in each group will be selected. - Subjects with a larger average stratum corneum area measured from both the left and right hands, and with a difference of less than 15% between the two values, will be selected. Key exclusion criteria - - Subjects with excessive sunburn on the test area at the time of consent. - Subjects with wounds, warts, or skin conditions (such as urticaria, inflammation, eczema, trauma, acne, or pimples) on the test area at the time of consent. - Subjects receiving treatment or preventive measures (such as hormone replacement therapy, pharmacotherapy, exercise therapy, dietary therapy, etc.) at medical institutions at the time of consent. - Subjects who have been exposed to ultraviolet rays beyond daily life, such as long hours of outdoor work, exercise, swimming, or leisure activities, from one month before the time of consent. - Subjects who have habitually applied or adhered makeup products, cosmetics, or quasi-drugs to the test area from one month before the time of consent. - Subjects who have shaved, depilated, or removed hair from the test area from one month before the time of consent. - Subjects who have received special skincare treatments (such as beauty salons or esthetic treatments) on the test area from one month before the time of consent. - Subjects who have habitually washed the test area with hard materials like nylon products from one month before the time of consent. - Subjects who have participated in other human trials (using cosmetics, foods, pharmaceuticals, quasi-drugs, medical devices, etc.) from one month before the time of consent. - Subjects who have habitually applied or adhered medical pharmaceuticals to the test area from six months before the time of consent. - Subjects who have previously received cosmetic medical treatments (such as Botox injections, hyaluronic acid or collagen injections, photofacials, etc.) on the test area. - Subjects with a history of hypersensitivity to cosmetics or other products, or those who may exhibit allergic symptoms. - Subjects with a history or current condition of atopic dermatitis, or those judged by the principal investigator to have symptoms resembling atopic dermatitis. Target Size - 60

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2023 Year 11 Month 20 Day Date of IRB - 2023 Year 12 Month 07 Day Anticipated trial start date - 2024 Year 01 Month 12 Day Last follow-up date - 2024 Year 05 Month 10 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065400

Disclaimer: Curated by HT Syndication.