NCT02568150

Evaluation Onset Time of DWP450-004 and Safety in Moderate-severe Glabellar Lines

Single Arm, Open, Single Institute, Domestic Phase 4 Clinical Study to Evaluate the Onset Time of Improvement of Glabellar Frown Lines and Safety of DWP450-004 Injection for Adults With Worse Than Moderate Glabellar Frown Lines

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evaluate onset time and safety of improvement effect of each group's forehead wrinkles after 2, 3, 4, 5, 14 days from administration of 20U dosage of DWP450-004 for adult patients who need more than moderate improvement of forehead wrinkles.

Detailed description

Currently, botulinum type A toxin related products are used not only in treatment areas but they are used often in cosmetic area as well and frequency of usage is increasing as well. Daewoong Pharmaceutical Co., Ltd. has developed a safe product by identifying wild-type Clostridium botulinum (type A) strain and purifying high purity, high quality botulinum toxin type A proteins from the strain. As a result of characteristic analysis (genotype analysis, morphological / biochemical characteristic verification test, toxicity test, etc) of the identified fungi, it was confirmed that the biological and chemicophysical properties are equal to those of wild-type Clostridium botulinum (type A, Hall strain). Regarding treatment satisfaction of those patients who were administered with botulinum toxin product, onset time plays an important role as a factor. Limitation found when reviewing the existing publications was in defining onset time solely on the determination of effect simply on response to whether there was an improvement. However, this study defines improvement rate of glabellar lines as ratio of reduction of more than 1 point from the baseline by investigator and thus it appears more objective data can be obtained than existing studies. Therefore, with this background, we intend to conduct phase 4 clinical study to explore onset time for DWP450-004 injection's glabellar lines improvement effect.

Conditions

• Moderate-severe Glabellar Lines

Interventions

Type	Name	Description
BIOLOGICAL	Single group, open-label

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2015-10-05
• Last updated: 2015-10-05