Safety and Efficacy Study of ATGC-100 for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

EuBiologics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Moderate to Severe Glabellar Lines

Treatments: Biological: Botox®; Biological: ATGC-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT03970876

CBA-PLN-001

Details and patient eligibility

About

Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is assessed after 12 weeks of administration of 20U of ATGC-100. In phase II clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled, and efficacy and safety are assessed by comparing with Botox (Allergan).

Enrollment: 60 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males and females aged between 19 to 65 years old
2. Subjects attaining ≥ grade 2 in the investigator's rating of the severity of glabellar line at maximum frown
3. Subjects who voluntarily signed the informed consent

Exclusion criteria

1. Subjects with general neuromuscular synaptic disorders
2. Presence or history of eyelid and/or ptosis
3. Subjects with noticeable facial asymmetry
4. Inability to substantially lessen glabellar frown lines even by physically spreading apart
5. Subjects who have administered the following drugs within 4 weeks prior to screening: Muscle relaxants, Anti-cholinergic agents, Benzodiazepine and similar drugs, Benzamide drugs, Tetracycline antibiotics, Lincomycin antibiotics, Aminoglycoside antibiotics
6. Subjects who are taking Anti-Coagulant and Anti-Platelet agent
7. Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of investigational drug
8. Subjects with skin disorders at the injection site
9. Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in glabellar region
10. Subjects with prior filler treatments which would have interfered with the evaluation of the efficacy of the study treatment
11. Any other planned facial aesthetic procedure in the glabellar area during the trial period
12. Previous treatment with botulinum toxin in the forehead within the last 5 months or any planned treatment during the study period
13. A history of drug or alcohol abuse
14. Condition including anxiety disorder, or any other significant psychiatric disorder (e.g. depression), in the investigator's opinion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

ATGC-100 (Phase I/II)

Experimental group

Description:

ATGC-100 will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml)

Treatment:

Biological: ATGC-100

Botox® (Phase II)

Active Comparator group

Description:

Botox® will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml)

Treatment:

Biological: Botox®