Forehead Rhytides
Conditions
Keywords
Diffusion, botulinum toxin, forehead wrinkle, split-face, controlled trial
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
Interventions
DRUGLetibotulinum 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.
DRUGPrabotulinum 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.
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.
Sponsors
Korea International Cooperation Agency (KOICA)
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
The allocation of treatment to the left or right side of the forehead was determined according to the randomization schedule and was concealed from both the investigators administering the treatment and the evaluators conducting outcome assessments, thereby maintaining a double-blind protocol throughout the study period.
Intervention model description
For each participant, the forehead was divided along the midline, with one side randomly assigned to receive the letibotulinum toxin A (Botulax®; intervention group) and the contralateral side assigned to receive one of two comparator botulinum toxin A formulations, prabotulinum toxin A (Nabota®) or onabotulinum toxin A (Botox®) (control groups 1 and 2, respectively)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety and Local Tolerability of Botulinum Toxin A Products | 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. |
Countries
South Korea
Outcome results
None listed