Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study III (BLESS III)

Phase 1

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

• Registration Number: EUCTR2018-003983-30-AT
• Lead Sponsor: Croma-Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-07
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 353

Inclusion Criteria

Subjects who meet ALL the following criteria are eligible for this study:
- Aged = 18 years or older at the time of screening (upper limit 75 years, inclusive).
- Has moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on FWS) 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 FWS), without glasses
obstructing the forehead area.
- The moderate to severe glabellar lines have an important psychological impact on the subject, as indicated by scores >0 on either
the Emotional or the Social Functioning subscale of the modified Skindex-16 (GL-QoL).
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 310
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43

Exclusion Criteria

Subjects who meet ANY of the following criteria are NOT eligible for this study:
- 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 trial (other than the investigational treatment).
- Known hypersensitivity to the 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 3 months prior to screening or planned during the study.
- Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers,) within 12 months prior to screening or planned during the study.
- Previous insertion of permanent material in the glabellar area or planned during the study.
- Any surgery, or history of surgery, in the glabellar area including surgical removal of the corrugator, procerus or depressor supercili
muscles or a combination of these, or scars in the glabellar area, or such surgery planned during the study.
- Active skin disease/infection or irritation at the treatment area.
- Inability to substantially lessen glabellar frown lines even by physically spreading them apart.
- Use of a muscle relaxant, within 2 weeks prior to screening or planned 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 trial.
- 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 anaesthetic (use of local anaesthetic outside the glabellar area is permitted).
- Participation in another clinical study within one month of screening and throughout the trial.
- 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