Clinical Trial: A Multicenter Randomized Half-Face Controlled Study Evaluating the Efficacy and Safety of Short-Contact Therapy Using a High-Concentration Azelaic Acid Derivative Face Mask in Patients with Acne Vulgaris (Japan)

Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062385) titled 'A Study to Evaluate the Effects of a High-Concentration Azelaic Acid Derivative Face Mask on Acne Vulgaris' on Aug. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Nishi-Shinjuku Skin Care Clinic

Condition: Condition - Acne Vulgaris Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the efficacy, durability of response, and safety of short-contact therapy using a high-concentration azelaic acid derivative face mask in addition to standard therapy in patients with acne vulgaris. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Short-contact therapy using a high-concentration azelaic acid derivative face mask (cosmetic) and Standard therapy for acne vulgaris Interventions/Control_2 - Standard therapy for acne vulgaris

Eligibility: Age-lower limit - 16 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 16 years or older with acne vulgaris who have approximately symmetrical facial lesions, at least six inflammatory lesions and five non-inflammatory lesions on each side of the face, are receiving standard treatment under health insurance coverage, have no history of azelaic acid treatment, and have no known allergy to azelaic acid. Key exclusion criteria - Patients with facial eczema, dermatitis, or other significant skin disorders; patients who have participated in another clinical study within the previous 3 months; patients with severe cardiac, renal, hepatic, respiratory, or cardiovascular disorders; and patients considered unsuitable for participation by the principal investigator. Target Size - 40

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 07 Month 14 Day Date of IRB - 2026 Year 05 Month 21 Day Anticipated trial start date - 2026 Year 07 Month 22 Day Last follow-up date - 2027 Year 08 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071399

Disclaimer: Curated by HT Syndication.