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Completed

NCT Number: 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

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

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Key information

Conditions

Forehead Rhytides

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Letibotulinum toxin A

Drug

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.

Other names: Botulax

Prabotulinum toxin A

Drug

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.

Other names: Nabota

Onabotulinum toxin A

Drug

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.

Other names: Botox

Primary outcomes

  1. Area of Anhidrosis

    Time frame: 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 outcomes

  1. Wrinkle Improvement

    Time frame: 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.

Other outcomes

  1. Safety and Local Tolerability of Botulinum Toxin A Products

    Time frame: From baseline to 2 weeks post-injection

    All adverse events were monitored and recorded throughout the study. Severity and causal relationship to the investigational products were evaluated by the investigators. Serious adverse events were reported according to a predefined protocol. Local tolerability assessments focused on erythema, swelling, hypersensitivity reactions, and muscle weakness at injection sites.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Korea International Cooperation Agency (KOICA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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