Health TrialsbyHealthPanel

Study of DWP450 in Japanese Subjects With Glabellar Lines

ConditionGlabellar Lines
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-64
SponsorDaewoong Pharmaceutical Co. LTD.

About this trial

Study to Evaluate the Efficacy and Safety of DWP450 in Japanese Subjects with Moderate to Severe Glabellar Lines

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • DWP450 20 U

    Drug

    Clostridium botulinum Toxin type A

  • 0.9% Saline Solution 0.5 mL

    Drug

    Normal Saline 0.5 mL

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: DWP450Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site

Time frame
Week 4

Secondary outcomes

1

The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site

Time frame
Week 8, 12
2

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

Time frame
Week 4, 8
3

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

Time frame
Week 4, 8

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daewoong Pharmaceutical Co. LTD.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: