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

Not Applicable

Completed

• Conditions: Forehead Rhytides
• Interventions: Drug: Letibotulinum toxin A; Drug: Prabotulinum toxin A; Drug: Onabotulinum toxin A

• Registration Number: NCT07072806
• Lead Sponsor: Yonsei University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-14
• Primary Completion: 2022-08-26
• Study Completion: 2022-09-07
• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment arm A	Letibotulinum toxin A	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 arm A	Prabotulinum toxin A	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 arm B	Letibotulinum toxin A	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 arm B	Onabotulinum toxin A	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.

Primary Outcome Measures

Name	Time	Method
Area of Anhidrosis	2 weeks post-injection	The area of anhidrosis (sweat suppression) at each injection site will be measured using the Minor iodine-starch test to evaluate diffusion characteristics of botulinum toxin A formulations. The test is conducted under controlled temperature and humidity. Image-based quantification will be used to calculate the diffusion area in cm².

Secondary Outcome Measures

Name	Time	Method
Wrinkle Improvement	Baseline and 2 weeks post-treatment	Wrinkle improvement was assessed 2 weeks after injection using digital photography and 3D imaging systems. Antera 3D was used to quantify the indentation index and maximal wrinkle relaxation length. Morpheus imaging was employed for three-dimensional visualization of muscle contraction and to evaluate maximal wrinkle depth. Measurements were taken on both lateral and medial sections of the forehead.

Trial Locations

Locations (1)

Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of