Study to compare the efficacy, time to onset, and duration of effect of Botulinum Type A Toxins in the treatment of glabellar frown lines

Phase 1

• Conditions: Therapeutic area: Body processes [G] - Biological Phenomena [G16]; moderate to severe glabellar frown lines at maximum frown; MedDRA version: 21.1Level: LLTClassification code 10052609Term: Glabellar frown linesSystem Organ Class: 100000004858

• Registration Number: EUCTR2019-003481-41-AT
• Lead Sponsor: Croma-Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-31
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18 - 75 years of age, inclusive, at the time of Screening.
• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 176
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

• 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified