Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062384) titled 'A Study to Evaluate the Effects of AviClear Laser Therapy Combined with Standard Treatment for Acne' on Aug. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is 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 - The purpose of this study is to evaluate the efficacy and safety of AviClear in combination with standard therapy in patients with acne vulgaris and to determine whether the combination treatment provides greater improvement in acne lesions and facilitates remission compared with standard therapy alone. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Standard therapy for acne vulgaris plus AviClear laser treatment administered to one randomly assigned side of the face at baseline, Week 4, and Week 8. 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 fewer than three cysts or nodules, are receiving standard acne treatment according to clinical guidelines or are untreated at enrollment, and have at least six inflammatory lesions and five non-inflammatory lesions (comedones) on each side of the face with comparable bilateral severity. 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 - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 06 Month 12 Day Date of IRB - 2023 Year 04 Month 23 Day Anticipated trial start date - 2026 Year 07 Month 22 Day Last follow-up date - 2027 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071394

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