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Clinical trial

Double-blind, Randomized, Parallel Design, Active-controlled Phase 1 Clinical Trial to Evaluate the Efficacy and Safety of DWP712 and Botox® in Adult Patients in Need of Moderate to Severe Glabellar Lines

ID
Name
DW_DWP712101
Description
To evaluate the safety of 12-week administration of DWP712 inj. in subjects with moderate to severe glabellar lines.
Trial arms
Trial start
2023-11-28
Estimated PCD
2024-02-26
Trial end
2024-03-21
Status
Completed
Phase
Early phase I
Treatment
DWP712
Clostridium botulinum Toxin
Arms:
DWP712
BOTOX®
Clostridium botulinum Toxin
Arms:
Botox®
Size
20
Primary endpoint
Number of occurrences for grade 3 or higher adverse drug reactions (ADRs) according to CTCAE 5.0
At 4, 8, 12 week after the injection
Eligibility criteria
Inclusion Criteria: * Subjects with facial wrinkle scale (FWS) score of visual appearance of glabellar lines ≥2 (moderate) at maximum frown as assessed by the investigator at screening Exclusion Criteria: -
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2024-04-04

1 organization

2 products

1 indication

Organization
Daewoong Pharmaceutical Co. LTD.
Product
DWP712
Indication
Frown Lines
Product
BOTOX®