Glabellar Lines
Conditions
Brief summary
Study to Evaluate the Efficacy and Safety of DWP450 in Japanese Subjects with Moderate to Severe Glabellar Lines
Interventions
DRUGDWP450 20 U
Clostridium botulinum Toxin type A
DRUG0.9% Saline Solution 0.5 mL
Normal Saline 0.5 mL
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female participants aged 18 to 64 years at the time of informed consent who have been Japanese nationals since birth * At both the Screening Visit (Visit 1) and the Baseline Visit (Visit 2), a DW-FWS score of ≥2 (moderate) for glabellar lines at maximum frown, as assessed by the investigator at the study site * Subjects who are able to understand and comply with the study procedures and visit schedule * Subjects who have voluntarily provided written informed consent to participate in this clinical study
Exclusion criteria
* Subjects who are judged by the investigator to have glabellar lines that are not expected to improve sufficiently due to limitations, such as wrinkles at rest that do not disappear when manually stretched. * Subjects who plan to undergo treatment with botulinum toxin products or any facial cosmetic procedures that may affect glabellar or forehead wrinkles (e.g. filler injections, photorejuvenation therapy, chemical peels, anti-wrinkle treatments, facelift, etc.) during the period from the Screening Visit (V1) to the End-of-Study Visit including the extension period. * Female and male subjects of childbearing potential who are planning pregnancy during the study period or who are unwilling to use acceptable methods of contraception (pregnant or breastfeeding women are also excluded.) * Subjects who have participated in another clinical trial and received or used an investigational drug or medical device within 1 month (4 weeks) prior to the Screening Visit (V1). * Subjects who have a significant medical history that is considered by the investigator to make them unsuitable for participation in this clinical study (e.g., malignancy, immunodeficiency, cardiovascular disease, pulmonary disease, renal disease, hepatic disease, alcohol or drug dependence, psychiatric disorders, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site | Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site | Week 8, 12 |
| The responder rate for glabellar lines at rest, as assessed by investigators at the study site, among subjects with an investigator-assessed baseline at-rest DW-FWS score of 2 or 3 | Week 4, 8 |
| The responder rate for glabellar lines maximum frown, as assessed by independent evaluators based on photographs, among subjects with an independent evaluators-assessed baseline at maximum frown DW-FWS score of 2 or 3 | Week 4, 8 |
Contacts
CONTACTKim
Outcome results
None listed