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 University20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Forehead Rhytides

Interventions

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.

Prabotulinum toxin ADRUG

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.

Onabotulinum toxin ADRUG

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Area of Anhidrosis

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.

Time frame: 2 weeks post-injection

Secondary Outcomes

Wrinkle Improvement

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.

Time frame: Baseline and 2 weeks post-treatment