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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568150
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Brief 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.

Condition or disease Intervention/treatment Phase
Moderate-severe Glabellar Lines Biological: Single group, open-label Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Intervention
Onset time of improvement effect of glabellar lines at maximum frown of botulinum toxin treatment
Biological: Single group, open-label



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Males and Females who are at least 20 years old and not older than 65 years old
  2. Subjects who have a least 2 points (moderate) of glabellar lines at maximum frown to the maximum confirmed with investigator's line assessment severity.
  3. Subjects who can comply well with clinical study procedures and visit schedules
  4. Subjects who voluntarily signed the Informed Consent Form

Exclusion Criteria

  1. Subjects with diseases that can affect neuromuscular functioning such as oderate muscle weakness, Eaton-Lambert Syndrome, Amyotrophic side sclerosis, motor neuropathy, etc.
  2. Subjects who took aminoglycoside antibiotics, curare-like agents or drugs that inhibit neuromuscular functioning (including muscle relaxants, anticholinergic type, benzodiazepine type, benzamide type, tetracycline type, or lincomycin type of antibiotics) within 4 weeks prior to screening
  3. Subjects with skin abnormality near the injection site such as infection, skin disease, or scar
  4. In case where subject underwent other procedures that may affect the glabellar lines or brow area within 6 months prior to screening
  5. Subjects who received botulinum Type A toxin products within 8 months prior to screening or received botulinum Type B products within 8 months prior to screening
  6. Subjects whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands.
  7. Subjects with facial paralysis or history of blepharoptosis
  8. Subjects who are pregnant, lactating or who plan to be pregnant during the clinical period or females of child bearing years who do not use available contraceptive methods (subjects of child bearing years must be negative from a pregnancy test prior to injection.)
  9. Subjects allergic to or sensitive to the Investigational Product or applicable ingredients
  10. Subjects taking aspirin, NSAIDs or anticoagulant
  11. Subjects who have participated in another clinical study within 30 days prior to screening or patient who participated in a clinical study and the period of 5 times the Investigational Product's half life has not passed
  12. Other subjects who are deemed not to be appropriate for this clinical study in the discretion of investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568150


Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Investigators
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Study Chair: Joon Pio Hong, MD Asan Medical Center
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT02568150    
Other Study ID Numbers: DW_DWP450004
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: October 2015