Use of Botulinum Toxin A in Direct Eyebrow Lift Scar: a Randomized Controlled Clinical Trial

73675523.7.0000.0068

Prospective, controlled and randomized study in which participants indicated for surgery to direct eyebrow lift will be randomized into two groups. In addition to surgery, the patients will be treated with botulinum toxin in one eyebrow and saline (placebo) in the other site. The patients participate as treatment and placebo at the same time. Assessments will be carried out through non-invasive exams.

2024-01-01

2025-01-01

2026-01-01

Recruiting

Early phase I

40

Inclusion Criteria: * Patients over 18 years of age with indication for direct eyebrow lift surgery. Exclusion Criteria: * Vulnerable groups: children, pregnant women and immunosuppressed patients * Allergy to botulinum toxin A * Patients under 18 years old * Women who are breastfeeding * Patients with muscular/neuromuscular diseases such as myasthenia gravis and amyotrophic lateral sclerosis * Patients who underwent botulinum toxin A injection in the last 6 months prior to surgery * Patients with a history of radiotherapy, chemotherapy or hematological disorders * Refusal to participate in the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-06-18