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

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.

Study Overview

• Status: Completed
• Conditions: Moderate-severe Glabellar Lines
• Intervention / Treatment: Biological: Single group, open-label

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Onset time of improvement effect of glabellar lines at maximum frown confirmed with Investigator's line assessment severity after administration	14 days

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Study Chair: Joon Pio Hong, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimate): October 5, 2015

Study Record Updates

• Last Update Posted (Estimate): October 5, 2015
• Last Update Submitted That Met QC Criteria: October 1, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWP450004