A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines

NCT04281095 | Completed Phase 1

• 1 other identifier: CBAP-PLN-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment

  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 Outcomes (4)

• Glabellar line improvement rate at maximum frown confirmed by investigator's live assessment

  0, 8, 12 weeks after the administration

• Glabellar line improvement rate at rest confirmed by investigator's live assessment

  0, 4, 8, 12 weeks after the administration

• Glabellar line improvement rate at rest confirmed by subject's assessment

  0, 4, 8, 12 weeks after the administration

• Subject satisfaction rate

  0, 4, 8, 12 weeks after the administration

Study Arms (2)

Botulinum toxin type A(ATGC-110)

EXPERIMENTAL

Drug: Botulinum toxin type A

Botulinum toxin type A

ACTIVE COMPARATOR

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

Total of 20U/0.5mL is intramuscularly administered to five points of the glabellar region, 4U/0.1mL each

Botulinum toxin type A; Botulinum toxin type A(ATGC-110)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• ATGC Co., Ltd.: lead

Study Sites (1)

Nowon Eulji Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 24, 2020
• Study Start: November 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)