NCT07072806

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

Diffusion Characteristics and Efficacy of Letibotulinum Toxin A in Forehead Wrinkle Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Forehead Rhytides

Interventions

Type	Name	Description
DRUG	Letibotulinum toxin A	Letibotulinum toxin A (Botulax) is a botulinum toxin type A formulation developed for aesthetic indications. In this trial, it was administered as the test intervention. Each participant received 2 units injected at four forehead sites (total 8 units), diluted to 20 U/mL, on one side of the forehead. The diffusion characteristics and efficacy were compared with those of onabotulinum and prabotulinum toxin A in a double-blind, randomized, split-face design.
DRUG	Prabotulinum toxin A	Prabotulinum toxin A (Nabota) is a botulinum toxin type A product approved for aesthetic use in South Korea and other countries. It was used as a comparator agent in this trial. Participants received subcutaneous injections at four forehead sites (2 units per site, 8 units total), diluted to 20 U/mL, on one side of the forehead in a randomized, split-face design.
DRUG	Onabotulinum toxin A	Onabotulinum toxin A (Botox) is an FDA-approved botulinum neurotoxin type A formulation used for cosmetic treatment of glabellar lines and other facial wrinkles. In this study, it was injected subcutaneously into the forehead at four standardized sites at a dose of 2 units per site (8 units total), diluted to 20 U/mL, and used as a comparator in the split-face design.

Timeline

• Start date: 2022-06-14
• Primary completion: 2022-08-26
• Completion: 2022-09-07
• First posted: 2025-07-18
• Last updated: 2025-07-18

Locations

1 site across 1 country: South Korea