Clinical Trial: A Prospective Randomized Double-Blind Split-Scar Trial Evaluating the Efficacy and Safety of Botulinum Toxin Type A Injection for Scars After Sub-Brow Blepharoplasty (Japan)

Tokyo, May 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061662) titled 'A Prospective Randomized Double-Blind Split-Scar Trial Evaluating the Efficacy and Safety of Botulinum Toxin Type A Injection for Scars After Sub-Brow Blepharoplasty' on May 22.

Study Type: Interventional

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

Primary Sponsor: Institute - Oculofacial Clinic Tokyo

Condition: Condition - Postoperative scars after sub-brow blepharoplasty Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether peri-incisional injection of botulinum toxin type A after sub-brow blepharoplasty improves postoperative scar width, erythema, firmness, elevation, and patient satisfaction. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Peri-incisional injection of botulinum toxin type A after sub-brow blepharoplasty. Interventions/Control_2 - Peri-incisional injection of an equal volume of normal saline on the contralateral side as placebo control.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 18 years or older who are scheduled to undergo bilateral sub-brow blepharoplasty, are eligible for split-scar comparison, are able to complete postoperative follow-up for 6 months, and provide written informed consent after receiving a full explanation of the study. Key exclusion criteria - Patients with a history of hypersensitivity or allergy to botulinum toxin type A preparations Patients with neuromuscular junction disorders, such as myasthenia gravis or Lambert Eaton syndrome Patients with systemic diseases that may affect wound healing Patients with a history of keloid formation or hypertrophic scarring Pregnant or breastfeeding women, or women who may be pregnant Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 20 Day Date of IRB - 2026 Year 05 Month 20 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2027 Year 06 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070553

Disclaimer: Curated by HT Syndication.