Tokyo, Feb. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060768) titled 'Evaluation Study of a Formulation on Aging-Related Skin Parameters' on Feb. 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

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

Condition: Condition - healthy volunteers Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy of the topical test product on aging-related skin conditions, particularly facial redness, in healthy Japanese women with subjective awareness of facial redness, following 8 weeks of application.

Efficacy will be assessed at Week 0 (baseline), Week 4, and Week 8, and compared with placebo using a split-face design. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - topical test product.The topical test product will be applied to one side of the face for 8 weeks. Interventions/Control_2 - The placebo product will be applied to the contralateral side of the face.

Eligibility: Age-lower limit - 30 years-old = Gender - Female Key inclusion criteria - Subjects meeting all of the following criteria will be included: 1. Healthy Japanese females aged 30 to 60 years at the time of informed consent 2. Subjects who are able to understand the study procedures and provide written informed consent 3. Subjects who are able to use the investigational product as instructed during the study period 4. Subjects who have subjective awareness of facial redness Key exclusion criteria - Subjects meeting any of the following criteria will be excluded: 1. Subjects with any dermatological condition at the study site or systemic condition that may affect study evaluation 2. Subjects with a history of medication use, medical treatment, or medical/cosmetic procedures that may affect the study results 3. Subjects with a history of severe hypersensitivity or allergy to drugs, cosmetics, or related products 4. Subjects who are pregnant, breastfeeding, or possibly pregnant 5. Subjects who are currently participating in another clinical trial or planning to participate in another clinical trial 6. Subjects who are likely to experience significant changes in living environment or external factors (e.g., ultraviolet exposure) during the study period that may affect the evaluation 7. Subjects who are unable to comply with study procedures or provide adequate cooperation 8. Subjects who are judged by the principal investigator to be unsuitable for participation for any reason Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 28 Day Date of IRB - 2026 Year 02 Month 26 Day Anticipated trial start date - 2026 Year 03 Month 02 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069516

Disclaimer: Curated by HT Syndication.