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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

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 - SBB-BTX Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061662
Enrollment
50
Registered
2026-05-22
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative scars after sub-brow blepharoplasty

Interventions

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

Sponsors

Oculofacial Clinic Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Difference in scar width between the botulinum toxin type A-treated side and the untreated side at 6 months postoperatively

Secondary

MeasureTime frame
Postoperative scar erythema Postoperative scar firmness Postoperative scar elevation POSAS score Vancouver Scar Scale (VSS) Patient satisfaction Evaluator satisfaction Adverse events (e.g., ptosis, asymmetry, facial expression disturbance) Delayed wound healing Surgical site infection

Countries

Japan

Contacts

Public ContactSaori Kotaki

Oculofacial Clinic Tokyo Department of Ophthalmology

saorit1013@yahoo.co.jp03-5579-9995

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026