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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06212960
Other study ID # DW_DWP712101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 28, 2023
Est. completion date March 21, 2024

Study information

Verified date January 2024
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety of 12-week administration of DWP712 inj. in subjects with moderate to severe glabellar lines.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 21, 2024
Est. primary completion date February 26, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility 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: -

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
DWP712
Clostridium botulinum Toxin
BOTOX®
Clostridium botulinum Toxin

Locations

Country Name City State
Korea, Republic of Chung-Ang University Hosptial Seoul

Sponsors (1)

Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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