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| Name | Class |
|---|---|
| Korea International Cooperation Agency (KOICA) | UNKNOWN |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm A | Active Comparator | 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. |
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| Treatment arm B | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Local Tolerability of Botulinum Toxin A Products | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
Individual participant data (IPD) will not be shared due to privacy concerns and institutional policies that restrict data sharing beyond the research team. Data were collected under a protocol that did not include participant consent for public or external data sharing.
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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)
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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.
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| 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. |
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| 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. |
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| Baseline and 2 weeks post-treatment |
| From baseline to 2 weeks post-injection |
| ID | Term |
|---|---|
| C000629279 | onabotulinum toxin A |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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