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This study will be conducted in Phase Ⅲ clinical trials. In Phase Ⅲ, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the glabellar lines. The investigational product is administered once, maintaining double-blind for a total of 16 weeks of observation. Thereafter, efficacy and safety are assessed by comparing with BOTOX® after regular visits conducted at 4,8,12 and 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROTOXIN(Phase Ⅲ) | Experimental | PROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL) |
|
| Botox® (Phase Ⅲ) | Active Comparator | Botox® will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROTOXIN | Biological | Botulinum toxin Type A |
| |
| Botox® |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4 | The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe | 4 weeks post injection compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-rated improvement rate of glabellar lines at maximum frown | The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe | Week 8, 12, 16 |
| Participant-rated improvement rate of glabellar lines at maximum frown |
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Inclusion Criteria:
Exclusion Criteria
Those with or accompanied by the following diseases at the time of screening
Subjects with wrinkles that physically prevent wrinkles from spreading, such as when wrinkles are not spread out by hand
Subjects who is administering a drug with muscle relaxation within four weeks of screening.
Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of the investigational drug
Subjects with surgical history who may affect wrinkles around the forehead or glabellar region
Subjects who have planned facial cosmetic procedure during the clinical trial
Subjects who have been administered similar drugs within 12 weeks (Botulinum toxin type A) or within 16 weeks (Botulinum toxin type B) before screening
Subjects who are expected to administer botulinum toxin preparations other than Investigational product during the clinical trial period
Subjects with allergy or hypersensitivity to the botulinum toxin or their components
A history of drug or alcohol abuse
Anxiety disorders or other significant mental disorders based on the judgment of an investigator
Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception
Pregnant or lactating women
Subjects with severe comorbidities or acute diseases that does not suitable for participation in clinical trials
Those who participated in other clinical trials/clinical medical device trials within 30 days prior to screening and who received Investigational product/medical devices/procedures, or those who had less than 5 times the half-life of the Investigational product
Subjects who are not eligible for this study based on the judgment of an investigator
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| Name | Affiliation | Role |
|---|---|---|
| Kim Beomjoon | Chung-Ang University Hospital, Chung-Ang University College of Medicine | Principal Investigator |
| Lee Yangwon | Konkuk University Medical Center | Principal Investigator |
| Kim Moonbeom | Pusan National University Hospital | Principal Investigator |
| Lee Jonghoon | Nown Eulji Medical Center, Eulji University | Principal Investigator |
| Shin Minkyung | Kyunghee University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital | Seoul | Dongdaemun-gu | South Korea | |||
| Chung-Ang University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41607140 | Derived | Son HS, Shin MK, Lee JH, Kim MB, Yoo KH, Choi SY, Han HS, Seok J, Kim BJ, Lee YW. Efficacy and Safety of Novel Botulinum Toxin Type A (Protoxin) in the Treatment of Moderate to Severe Glabellar Lines: A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Study. Ann Dermatol. 2026 Feb;38(1):33-41. doi: 10.5021/ad.25.124. |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Biological |
Botulinum toxin Type A |
|
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe |
| Week 4, 8, 12, 16 |
| Investigator-rated improvement rate of glabellar lines at rest | The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe | Week 4, 8, 12, 16 |
| Participant-rated improvement rate of glabellar lines at rest | The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe | Week 4, 8, 12, 16 |
| Independent photo evaluator-rated improvement rate of glabellar lines at frown | The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe | Week 4, 8, 12, 16 |
| Independent photo evaluator-rated improvement rate of glabellar lines at rest | The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe | Week 4, 8, 12, 16 |
| Participant-rated satisfaction after treatment | Participant evaluate the level of satisfaction by Patient Satisfaction(PS) 7-grade score(1 to 7) where 1 = very dissatisfied and 7 = very satisfied | Week 4, 8, 12, 16 |
| Seoul |
| Gwangjin-gu |
| South Korea |
| Konkuk University Hospital | Seoul | Gwangjin-gu | South Korea |
| Nowon Eulji Medical Center | Seoul | Nowon-gu | South Korea |
| Pusan National University Hospital | Pusan | Seo-gu | South Korea |
| 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 |