Tokyo, May 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061432) titled 'Evaluation of the Cosmetic Effects of a Cream Containing gamma-Oryzanol' on May 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Tsuno Rice Fine Chemicals Co., Ltd.

Condition: Condition - Healthy women Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Clinical Study on the Efficacy of a Cream Containing gamma-Oryzanol in Healthy Women Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will apply a cream containing rice bran-derived gamma-oryzanol to one side of the face twice daily (morning and evening) for 8 consecutive weeks. Assessments will be conducted on the cheek and forehead areas. Interventions/Control_2 - Participants will apply a placebo cream to one side of the face twice daily (morning and evening) for 8 consecutive weeks. Assessments will be conducted on the cheek and forehead areas.

Eligibility: Age-lower limit - 30 years-old

Gender - Female Key inclusion criteria - 1. Women between the ages of 30 and 60 at the time consent is obtained. 2. Healthy and free from chronic physical diseases, confirmed by medical interview. 3. The applicant must not be using any medicated cosmetics, supplements, or other products that are expected to have related efficacy. 4. Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding the details, and can provide written consent to participate in this trial. 5. Individuals who can attend the designated examination date and undergo the examination. 6. Individuals deemed suitable for participation in this trial by the principal investigator. Key exclusion criteria - 1. Who currently suffer from any disease and are under medication. 2. Who have been determined by the examining physician to have a serious skin condition such as dermatitis. 3. Who cannot intentionally refrain from being exposed to direct sunlight, such as sunburn, during the examination period. 4. Who show statistical outliers in measurements of primary and secondary endpoints. 5. Who have allergies (to pharmaceuticals or products related to the test materials). 6. Who is pregnant, lactating, or intends to become pregnant during the study period. 7. Who are currently, or have been within the past month at the time of consent, in the habit of continuously ingesting or applying a drug that relation to the area to be measured. 8. Who are otherwise deemed by the investigator to be inappropriate for the study. Target Size - 25

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 20 Day Date of IRB - 2026 Year 04 Month 28 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2026 Year 07 Month 16 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070104

Disclaimer: Curated by HT Syndication.