moderate to severe glabellar frown lines at maximum frown MedDRA version: 21.1 Level: LLT Classification code 10052609 Term: Glabellar frown lines System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Botulax
Product Name: BoNT/A-DP
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: Botulinum Neurotoxin Type A
CAS Number: 180016-51-6
Current Sponsor code:
Sponsors
Croma-Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of treatment with BoNT/A-DP as defined by the percentage of responders at Week 4 (Facial Wrinkle Scale [FWS] score of 0 or 1 and a = 1 point reduction in FWS score) in reducing the severity of glabellar frown lines at maximum frown (the worst appearance of upper facial lines with maximum load on the muscle; eyebrows pushed together as far as they can go) compared to treatment with Botox Cosmetic, based on independent investigator assessment and subject assessment.;Secondary Objective: • To assess the percentage of different responders after a single treatment with BoNT/A-DP compared to a single treatment of Botox Cosmetic at Weeks 1, 2, 4, 8, 12 and 16, based on independent investigator and subject assessments. • To assess time to onset of effect after a single treatment with BoNT/-DP compared to a single treatment of Botox Cosmetic, as measured at Weeks 1, 2, and 4, based on independent investigator and subject assessments. • To assess the duration of effect in subjects who respond after a single treatment with BoNT/A-DP or a single treatment of Botox Cosmetic, based on independent investigator and subject assessments. • To assess treatment satisfaction at Weeks 4, 12, and 16 using FACE-Q Satisfaction with Outcome Scale. • To determine the safety and presence of any adverse effects of a single treatment of BoNT/A-DP compared to a single treatment of Botox Cosmetic in the treatment of glabellar lines.;Primary end point(s): • An FWS score at the Week 4 Visit of 0 or 1 and a = 1 point reduction in FWS score at maximum frown relative to Baseline, based on investigator assessment. • An FWS score at the Week 4 Visit of 0 or 1 and a = 1 point reduction in FWS score at maximum frown relative to Baseline, based on subject assessment.;Timepoint(s) of evaluation of this end point: At week 4 after each treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of responders with an FWS score of 0 or 1 and a = 1 point reduction in FWS score at maximum frown at Weeks 1, 2, 8, 12 and 16, based on independent investigator assessment and subject assessment. 2. Percentage of responders with an FWS score of 0 or 1 and a = 2 point reduction in FWS score at maximum frown at Weeks 1, 2, 4, 8, 12 and 16, based on independent investigator and subject assessments. 3. Percentage of responders with an FWS score of 0 or 1 and a = 1 point reduction in FWS score at rest at Weeks 1, 2, 4, 8, 12 and 16, based on independent investigator and subject assessments. 4. Time to onset of effect, as measured at Weeks 1, 2, and 4, based on independent investigator and subject assessments. Onset of effect is defined as = 1 point improvement in Glabellar Line Scale - Investigator (GLS-I) and Glabellar Line Scale – Subject (GLS-S) score relative to Baseline at maximum frown in glabellar lines. In addition, onset of effect will be assessed by subjects daily during the first 2 weeks after treatment, by recordings in the subject diary. 5. For subjects who respond, duration of effect will be assessed based on independent investigator and subject assessments. Effect will be deemed to be lost when scores return to Baseline values. 6. The FACE-Q assessment at Weeks 4, 12 and 16.;Timepoint(s) of evaluation of this end point: time points are indicated within each endpoint above | — |
Countries
Austria, Canada, Germany, United States
Contacts
Public ContactSonja Hoeller
Croma-PHARMA GmbH
Outcome results
None listed