Phase 2
Completed N=352
Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines
Glabellar Frown Lines
Source: ClinicalTrials.gov NCT02184988 ↗
Enrolled (actual)
352
Serious AEs
2.0%
Results posted
Feb 2019
Primary outcomePrimary: The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year — 148 Participants
Summary
The purpose of this study is to demonstrate the safety of multiple doses of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe glabellar lines in adult subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year |
148 | — |
Eligibility Criteria
Inclusion Criteria (A subject must meet all of the following inclusion criteria in order to be eligible for enrollment in the study):
- Subjects must be an adult 18 years of age or over
- Subject is able to provide informed consent and comply with study instructions
- Subject has moderate to severe glabellar lines on maximum frown as assessed by the investigator using the GLS
- Subject is willing and able to complete the entire course of the study
Exclusion Criteria (A subject must not meet the following exclusion criteria in order to be eligible for enrollment in the stud)y:
- Previous treatment with botulinum toxin of any serotype in the forehead area within the last 8 months
- Previous treatment with any facial aesthetic procedure (e.g. injection with fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
- Previous insertion of permanent material in the glabellar area
- Planned treatment with botulinum toxin of any serotype in any other body region during the study period
- Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow)
- Energy based or cryo-therapy based treatment of facial muscles superior to the lateral canthus
- Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (subjects can continue with their usual skin care routine)
- Inability to substantially lessen glabellar frown lines even by physically spreading them apart
- Marked facial asymmetry
- Ptosis of eyelid and/or eyebrow, or history of eyelid and/or eyebrow ptosis
- History of facial nerve palsy
- Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin
- Any active infection in the area of the injection sites
- Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
- Evidence of recent alcohol or drug abuse
- Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
- Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
- Known allergy or hypersensitivity to botulinum toxin preparation
- Participation in another interventional clinical study within the last 30 days
Data sourced from ClinicalTrials.gov (NCT02184988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.