Clinical trial NCT04281095: A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glabellar Frown Lines
Lead sponsor: ATGC Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
timeFrame: 0 and 4 weeks after the administration
Secondary outcomes:
measure: Glabellar line improvement rate at maximum frown confirmed by investigator's live assessment
timeFrame: 0, 8, 12 weeks after the administration
measure: Glabellar line improvement rate at rest confirmed by investigator's live assessment
timeFrame: 0, 4, 8, 12 weeks after the administration
measure: Glabellar line improvement rate at rest confirmed by subject's assessment
timeFrame: 0, 4, 8, 12 weeks after the administration
measure: Subject satisfaction rate
timeFrame: 0, 4, 8, 12 weeks after the administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center
Study officials:
References: