- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04281095
A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines
July 7, 2020 updated by: ATGC Co., Ltd.
A Phase I/II Randomized, Double Blind, Active-controlled, Single Center Clinical Trial for Evaluation of Safety and Efficacy of ATGC-110, An Intramuscularly Administered Clostridium Botulinum Neurotoxin Type A, in Adult Patients With Moderate to Severe Glabellar Frown Lines
Efficacy and safety of the investigational product, ATGC-110, was evaluated in comparison with Botox for a total of 12 weeks after the administration in treatment of glabellar frown lines.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Nowon Eulji Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female subjects aged between 19 to 65 years
- Subjects assigned a glabellar line severity grade of 2 or greater (moderate) at maximum frown assessed by the Investigator
- Subjects who provide written consent to voluntarily participate in the study after receiving and understanding a detailed explanation of the study
Exclusion Criteria:
- Subjects with diseases that may affect neuromuscular function, such as Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis, or motor neuropathy
- Subjects with the history of eyelid paralysis or ptosis
- Subjects with significant facial asymmetry
- Individuals whose glabellar lines cannot be satisfactorily improved with physical methods since lines are not flattened even using hands
- Subjects who have received medication that inhibits neuromuscular function within the 4 weeks prior to screening such as muscle relaxants, anticholinergics, benzodiazepines and similar drugs, benzamides, tetracycline antibiotics, lincomycin antibiotics, and aminoglycoside antibiotics
- Subjects taking anticoagulants or antiplatelet agents (Use of low-dose aspirin (325 mg/day or less) to prevent blood clotting is allowed)
- Subjects who have received aspirin or NSAIDs within 7 days prior to administration of the IP.
- Subjects with skin abnormalities such as infection at the injection site, dermatopathy, or scars.
- Subjects with the history of treatment of the glabellar region (including the forehead) such as face lifting, permanent implants, or fillers
Subjects who have received other procedures that may affect the assessment of the glabellar or forehead lines during the following periods:
- Within 6 months of screening: facial plastic surgery such as tissue augmentation, brow lift, or dermal resurfacing.
- Within 6 months of screening: injection of dermal fillers with hyaluronic acid as the main ingredient.
- Within 12 months of screening: injection of dermal fillers with ingredients other than hyaluronic acid as the main ingredient.
- Individuals planning a facial cosmetic procedure (skin fillers, photorejuvenation, chemical/mechanical peeling, etc.) during the study period.
- Individuals who have received a botulinum toxin preparation within 5 months prior to screening or those who are expected to receive a botulinum toxin preparation for any other purpose than the indication of this study (glabellar lines).
- Subjects with the history of excessive alcohol consumption or drug addiction
- Individuals with an anxiety disorder or other significant psychiatric disorders (e.g., depression), which, in the Investigator's opinion, may affect study participation or objective assessment of efficacy outcomes
- Individuals who answered "yes" to any of the questions on the Columbia University Suicide Severity Rating Scale (C-SSRS) regarding a case within the past 12 months at the screening
- Female subjects of childbearing age who do not agree to practice contraception using medically allowed contraceptive methods during the study period (hormonal contraception, IUD (intrauterine device) or IUS (intrauterine system), tubal ligation, dual protection (using a combination of male condom, female condom, cervical cap, contraceptive diaphragm, or contraceptive sponge)
- Pregnant or lactating women
- Subjects who are allergic or sensitive to the IP or its components
- Individuals with concomitant illnesses that make them unsuitable for participation in the study by the Investigator such as malignant tumors, immunodeficiency (immune deficiency), kidney disease, liver disease, or lung disease
- Individuals who have participated in other clinical trials within 3 months prior to participating in this study and have received an IP or medical device during the previous clinical studies
- Individuals who are not eligible for this study for any reason as per the Investigator's discretion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Botulinum toxin type A(ATGC-110)
|
Total of 20U/0.5mL is intramuscularly administered to five points of the glabellar region, 4U/0.1mL each
|
ACTIVE_COMPARATOR: Botulinum toxin type A
|
Total of 20U/0.5mL is intramuscularly administered to five points of the glabellar region, 4U/0.1mL each
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
Time Frame: 0 and 4 weeks after the administration
|
Changes in the glabellar line severity at maximum frown from baseline to 4 weeks after the IP administration were evaluated by investigator
|
0 and 4 weeks after the administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glabellar line improvement rate at maximum frown confirmed by investigator's live assessment
Time Frame: 0, 8, 12 weeks after the administration
|
Changes in the glabellar line severity at maximum frown from baseline to 8 and 12 weeks after the IP administration were evaluated by investigator
|
0, 8, 12 weeks after the administration
|
Glabellar line improvement rate at rest confirmed by investigator's live assessment
Time Frame: 0, 4, 8, 12 weeks after the administration
|
Changes in the glabellar line severity at rest from baseline to 4, 8 and 12 weeks after the IP administration were evaluated by investigator
|
0, 4, 8, 12 weeks after the administration
|
Glabellar line improvement rate at rest confirmed by subject's assessment
Time Frame: 0, 4, 8, 12 weeks after the administration
|
Changes in the glabellar line severity at rest from baseline to 4, 8 and 12 weeks after the IP administration were evaluated by subjects
|
0, 4, 8, 12 weeks after the administration
|
Subject satisfaction rate
Time Frame: 0, 4, 8, 12 weeks after the administration
|
Subjects fill out the satisfaction questionnaire
|
0, 4, 8, 12 weeks after the administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2019
Primary Completion (ACTUAL)
April 30, 2020
Study Completion (ACTUAL)
April 30, 2020
Study Registration Dates
First Submitted
February 20, 2020
First Submitted That Met QC Criteria
February 20, 2020
First Posted (ACTUAL)
February 24, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 9, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBAP-PLN-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glabellar Frown Lines
-
Pacira CryoTech, Inc., a wholly owned subsidiary...CompletedGlabellar Frown Lines | Frown LinesUnited States
-
Pacira CryoTech, Inc., a wholly owned subsidiary...CompletedGlabellar Frown Lines | Frown LinesUnited States
-
Galderma R&DCompletedGlabellar Frown Lines | Canthal LinesUnited States
-
ATGC Co., Ltd.RecruitingGlabellar Frown LinesKorea, Republic of
-
Medy-ToxCompletedGlabellar Frown LinesAustralia
-
Galderma R&DActive, not recruitingGlabellar Frown LinesUnited States
-
Galderma R&DCompletedGlabellar Frown LinesUnited States
-
Galderma R&DCompleted
-
Revance Therapeutics, Inc.CompletedEfficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar LinesGlabellar Frown LinesUnited States
-
Revance Therapeutics, Inc.CompletedGlabellar Frown LinesUnited States, Canada
Clinical Trials on Botulinum toxin type A
-
AllerganTerminatedOveractive BladderSerbia, Turkey, Greece, Egypt, Lebanon, India
-
Daewoong Pharmaceutical Co. LTD.Completed
-
AllerganCompletedOveractive BladderPortugal, South Africa, Netherlands, Canada, Singapore, Brazil, United States, Taiwan, Italy, United Kingdom, France, Spain
-
AllerganCompletedOveractive BladderUnited Kingdom, Belgium, New Zealand, France, Russian Federation, Czech Republic, United States, Germany, Austria, Poland, Slovakia, Ukraine, Canada, Australia
-
Mentor Worldwide, LLCSynteract, Inc.CompletedGlabellar RhytidesUnited States
-
Brazilan Center for Studies in DermatologyCompletedWrinkles in Frontal AreaBrazil
-
HugelCompletedBenign Masseteric HypertrophyKorea, Republic of
-
Mentor Worldwide, LLCSynteract, Inc.CompletedGlabellar Rhytides | Frown Lines Between the EyebrowsUnited States
-
Medy-ToxCompletedCervical Dystonia
-
Seton Healthcare FamilyCompleted