Overview

This trial is active, not recruiting.

Condition glabellar lines
Treatments dysport, botox, abobotulinumtoxina placebo, onabotulinumtoxina placebo
Phase phase 3
Sponsor Ipsen
Start date April 2015
End date July 2016
Trial size 520 participants
Trial identifier NCT02450526, Y-52-52120-158

Summary

The objective of this study is to demonstrate the efficacy of Dysport for the improvement in appearance of moderate to severe glabellar lines and to assess the short term and long term safety of Dysport, used for the improvement in appearance of moderate to severe glabellar lines in Chinese subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Dysport, 50 Units, divided into five injections into the glabellar area. Administered in double blind fashion at cycle 1 followed by up to 4 cycles Dysport, 50 Units administered with an interval period depending on response, no less than 12 weeks between each treatment cycle.
dysport AbobotulinumtoxinA
(Active Comparator)
Botox will be administered in treatment cycle 1 only. On Day 1, 20 Units, divided into five injections into the glabellar area.
botox OnabotulinumtoxinA
(Placebo Comparator)
Dysport placebo will be administered in treatment cycle 1 only. On Day 1, 50 Units, divided into five injections into the glabellar area.
abobotulinumtoxina placebo
50 Units
(Placebo Comparator)
Botox placebo will be administered in treatment cycle 1 only. On Day 1, 20 Units, divided into five injections into the glabellar area.
onabotulinumtoxina placebo
20 Units

Primary Outcomes

Measure
The proportion of responders measured by the Investigator's Live Assessment (ILA) and the Subject's Self-Assessment (SSA) at maximum frown.
time frame: Day 29 of Cycle 1

Secondary Outcomes

Measure
The proportion of responders with respect to Independent Reviewer's assessment of photographs of the subject's glabellar lines at maximum frown (using the Photographic Scale).
time frame: Day 29 of Cycle 1
Mean Subject's Global Assessment (SGA) score
time frame: Day 29 of Cycle 1
The proportion of responders with respect to the SGA score.
time frame: Day 29 of Cycle 1

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Provision of written informed consent - Male or female Chinese subjects who are between 18 to 65 years of age inclusive. - Have moderate or severe wrinkles of vertical glabellar lines (Grade 2 or 3) at maximum frown at baseline (Day 1), as assessed by the subject using SSA. - Have moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at baseline (Day 1), as assessed by the Investigator using ILA. - Be Botulinum Toxin (BTX) naïve or have received their most recent BTX-A treatment more than 1 year prior to screening. - Have a negative pregnancy test - Have an understanding of the study Exclusion Criteria: - Any prior surgery affecting corrugator supercilii, prior blepharoplasty or brow lift, dermal resurfacing, or any prior cosmetic procedures or scars within 36 months. - Any prior treatment with permanent fillers in the upper face. - Any prior treatment with nonpermanent dermal fillers in the upper face within the past 3 years and/or skin abrasions/resurfacing, photorejuvenation or skin/vascular laser intervention within the past 12 months. - Any planned facial cosmetic surgery or procedures during the study period. - Lack of capacity to frown. - Facial conditions that could affect safety or efficacy results. - History of facial nerve palsy. - Marked asymmetry; ptosis; excessive dermatochalasis; deep dermal scarring; thick sebaceous skin; photodamage etc. - Presence of any condition that could affect the safety, conduct or outcome of the study. - Any subjects who have any psychiatric illness or are taking antidepressant, anxiolytic or antipsychotic medication. - Pregnant and/or lactating female subjects. - Female subjects of childbearing potential not willing to use contraceptive measures throughout the course of the study. - History of drug or alcohol abuse. - Treatment with an experimental drug or device within 30 days prior to screening for this study and during the conduct of this study. - Requirement for BTX injection to site(s) for disorders other than glabellar lines. - Known allergy or hypersensitivity to BTX. - Any medical condition or laboratory finding from central laboratory results. - The subject is unable and/or unwilling to comply fully with the protocol and the study. - Mental incapacity, unwillingness or language barriers.

Additional Information

Official title A Phase III, Randomised, Double Blind and Open Label Phase, Multicentre, Active and Placebo Controlled Study to Investigate the Efficacy and Safety of Dysport Including a Comparison to Botox in the Treatment of Moderate to Severe Glabellar Lines, and to Assess the Long Term Efficacy and Safety of Dysport Following Repeated Treatments in This Indication
Description The first treatment cycle will be double blind and subjects will be randomised to receive Dysport, Botox or placebo. After the first treatment cycle, all subjects will receive a maximum of four treatment cycles with Dysport, occurring at intervals of no less than 84 Days (12 weeks) between each treatment cycle, depending upon individual duration of response to Dysport treatment.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Ipsen.