Status:
COMPLETED
Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines
Lead Sponsor:
Croma-Pharma GmbH
Collaborating Sponsors:
Hugel
Conditions:
Frown Lines
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical consideratio...
Detailed Description
This will be a multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada. To allow all subjects to profit from treatment and to obtain ad...
Eligibility Criteria
Inclusion
- • Has moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on GLS-I/GLS-S) as determined by in clinic assessments by both the investigator and the subject (where: 0='none', 1='mild', 2='moderate', 3='severe').
- Subject has a stable medical condition with no uncontrolled systemic disease.
- Female subjects of childbearing potential must test negative for pregnancy and agree to use highly effective birth control during the course of the study.
- Subjects who wear glasses must be able to adequately self-assess the severity of their glabellar lines (according to the GLS-S), without glasses obstructing the forehead area.
Exclusion
- Previous treatment with any serotype of botulinum toxin for any indication within the 12 months prior to Screening, or any planned treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational treatment).
- Known hypersensitivity to either study medication or its excipients.
- Any medical condition that may place the subject at increased risk due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, profound atrophy or weakness in the target muscles, or any other condition (at the investigator's discretion) that might interfere with neuromuscular function or contraindicate botulinum toxin therapy.
- Facial laser or light treatment, microdermabrasion, superficial peels or retinoid therapy within the three months prior to Screening or planned during the study.
- o Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers, photo rejuvenation) within 12 months prior to Screening or planned during the study.
- Previous insertion of permanent material in the glabellar area, or planned insertion during the study.
- Any planned or history of surgery in the glabellar area and/or canthal line area, or scars in the glabellar and/or canthal line.
- Active skin disease/infection or irritation at the treatment area.
- Inability to substantially lessen glabellar frown lines and or lateral canthal lines even by physically spreading them apart.
- Use of a muscle relaxant within 2 weeks prior to Screening, or planned use during the study.
- Marked facial asymmetry or ptosis of eyelid and/or eyebrow, or current facial palsy or neuromuscular junction disorders as judged by the investigator.
- Pregnant, breastfeeding or planning to become pregnant during the study.
- Use of prohibited medication including anticholinergic drugs, or drugs which could interfere with neuromuscular function, including aminoglycoside antibiotics and curare-like compounds within 2 weeks prior to Screening or planned during the study.
- Planned surgery with general anesthetic (use of local anesthetic outside the glabellar area is permitted).
- Participation in another clinical study within one month of Screening and throughout the study.
- Previous participation in another botulinum toxin aesthetic study, which involved the treatment of glabellar, lines in combination with canthal lines and/or forehead lines in the previous 18 months.
- Chronic drug or alcohol abuse (as per investigator discretion).
Key Trial Info
Start Date :
June 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04763265
Start Date
June 24 2020
End Date
February 1 2021
Last Update
March 18 2025
Active Locations (5)
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1
ATS Clinical Research
Santa Monica, California, United States, 90404
2
Skin Research Institute LLC
Coral Gables, Florida, United States, 33146
3
Monika Sulovsky
Vienna, Austria, 1010
4
Institute Of Cosmetic
Oakville, Ontario, Canada, L6J7W5