Clinical Trial: Evaluation of Safety and Skin Condition Following Use of Test Cosmetics (Japan)

Tokyo, Feb. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060578) titled 'Evaluation of Safety and Skin Condition Following Use of Test Cosmetics' on Feb. 4.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Active

Primary Sponsor: Institute - TES Holdings Co., Ltd.

Condition: Condition - acne vulgaris Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the safety and skin condition of test cosmetics with different formulations when applied to one side of the face (left or right) for 12 weeks in subjects with mild to moderate acne vulgaris. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Apply the test product to the entire designated side of the face twice daily after washing in the morning and evening. Continue this for 12 weeks. Interventions/Control_2 - Apply the control product to the entire designated side of the face twice daily after washing in the morning and evening. Continue this for 12 weeks.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1) Individuals aged 18 to 39 years at the time of consent acquisition 2) Patients with mild to moderate acne vulgaris 3) Individuals with 10 or more inflammatory lesions on the face, up to approximately 40 lesions. No more than 2 nodules/cysts. Lesion counts on both sides are similar. 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, and can provide written consent to participate in this study. 5) Individuals who can attend the designated examination date and undergo the examination. 6) Individuals deemed suitable for participation in this study by the principal investigator. Key exclusion criteria - Individuals 1) currently receiving acne treatment with prescription medications from a medical institution. 2) with clinically abnormal facial skin conditions that could affect the objectives of this study. 3) with acne conglobata, acne fulminans, or secondary acne. 4) with underlying conditions or skin symptoms requiring local or systemic therapy that may affect this study. 5) diagnosed with polycystic ovary syndrome (PCOS). 6) with a history of hypersensitivity to ingredients in this trial cosmetic or to cosmetics in general. 7) who changed their facial cleansers or skincare products within the past month. 8) who received, or require, specified medications or therapies during the defined period. A) Topical agents and procedures applied to the study site and head. I. Topical agents i. who used the following products within 4 weeks.: -Formulations containing retinoids -Formulations containing azelaic acid ii. who used the following products within 2 weeks.: -Acne treatments such as antibacterial agents and anti-inflammatory agents -Products containing benzoyl peroxide -Adrenal corticosteroids -Products considered to have a keratolytic effect II. Procedures, etc. i. who received the following procedures within 4 weeks: -Surgery and cosmetic procedures such as chemical peels, laser treatments, phototherapy, or esthetic treatments. B) Systemic medications, etc. I. who used the following products within 12 weeks.: -Preparations containing retinoids II. who used the following products within 4 weeks.: -Other acne treatments -Adrenal corticosteroids -Preparations affecting sex hormones -Traditional Chinese medicine preparations considered effective for acne 9) with severe cardiac, renal, hepatic, respiratory, circulatory, or immunodeficiency conditions that make them unsuitable for the study. 10) who are pregnant, breastfeeding, may be pregnant, or plan to become pregnant during the study. 11) considered unsuitable for the study by the investigator team. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 24 Day Date of IRB - 2025 Year 12 Month 25 Day Anticipated trial start date - 2026 Year 02 Month 14 Day Last follow-up date - 2026 Year 05 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068925

Disclaimer: Curated by HT Syndication.