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
Disclaimer: Curated by HT Syndication.