A Study Comparing the Safety, Efficacy, and Diffusion of Letibotulinum Toxin A Versus Other Botulinum Toxin Products in Adults With Moderate-to-Severe Forehead Wrinkles

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Forehead Rhytides

Treatments: Drug: Onabotulinum toxin A; Drug: Letibotulinum toxin A; Drug: Prabotulinum toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT07072806

4-2021-1097

Details and patient eligibility

About

The goal of this clinical trial is to learn if letibotulinum toxin A is effective and safe for treating moderate-to-severe horizontal forehead wrinkles in adults. It will also compare its diffusion characteristics with two other botulinum toxin A products. The main questions it aims to answer are:

1. Does letibotulinum toxin A reduce forehead wrinkles as effectively as other botulinum toxin A products?
2. Does letibotulinum toxin A show more localized (smaller) diffusion after injection?

Researchers will compare letibotulinum toxin A with prabotulinum toxin A and onabotulinum toxin A (Botox®) to evaluate their diffusion profiles and wrinkle-reduction effects.

Participants will:

1. Receive botulinum toxin A injections on each side of the forehead (split-face design)
2. Undergo wrinkle assessments and sweat gland function testing using 3D imaging and iodine-starch tests
3. Return to the clinic 2 weeks after treatment for follow-up evaluation

Enrollment: 20 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants were eligible if they were aged ≥20 years with visible horizontal forehead wrinkles scored as moderate to severe on the Facial Wrinkle Scale using a photonumeric guide

Exclusion criteria

• Exclusion criteria included a history of BoNT-A injection or cosmetic procedures near the fore-head/orbital area within the past year; signs of infection or inflammation at the injection site; compen-satory frontal hyperactivity; neuromuscular disorders including myasthenia gravis or amyotrophic lateral sclerosis; use of anticoagulants, aminoglycosides, curare-like agents, or neuromuscular inhibitors (stable doses of muscle relaxants or benzodiazepines are permitted); and hypersensitivity to the inves-tigational product or iodine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Treatment arm A

Active Comparator group

Description:

The first treatment group received letibotulinum toxin A (Botulax) on one randomly assigned side of their face and prabotulinum toxin A (Nabota) on the other side of their face.

Treatment:

Drug: Prabotulinum toxin A

Drug: Letibotulinum toxin A

Treatment arm B

Active Comparator group

Description:

The first treatment group received letibotulinum toxin A (Botulax) on one randomly assigned side of their face and onabotulinum toxin A (Botox) on the other side of their face.

Treatment:

Drug: Letibotulinum toxin A

Drug: Onabotulinum toxin A