Evaluation Onset Time of DWP450-004 and Safety in Moderate-severe Glabellar Lines
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|ClinicalTrials.gov Identifier: NCT02568150|
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : October 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Moderate-severe Glabellar Lines||Biological: Single group, open-label||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Onset time of improvement effect of glabellar lines at maximum frown of botulinum toxin treatment
Biological: Single group, open-label
- Onset time of improvement effect of glabellar lines at maximum frown confirmed with Investigator's line assessment severity after administration [ Time Frame: 14 days ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568150
|Study Chair:||Joon Pio Hong, MD||Asan Medical Center|