Clinical trial NCT02450526: Dysport in the Treatment of Glabellar Lines in Chinese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Lines
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-05-21
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Superiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).
timeFrame: At Cycle 1, Day 29.
measure: Superiority Analysis of The Percentage of Responders Measured by the SSA at Maximum Frown at Cycle 1, Day 29 (DB Period).
timeFrame: At Cycle 1, Day 29.
measure: Non-Inferiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).
timeFrame: At Cycle 1, Day 29.
Secondary outcomes:
measure: The Percentage of Responders With Respect to Independent Reviewer's Assessment of Photographs of the Subject's Glabellar Lines at Maximum Frown at Cycle 1, Day 29 (DB Period).
timeFrame: At Cycle 1, Day 29.
measure: Mean Subject's Global Assessment (SGA) Score at Cycle 1, Day 29 (DB Period).
timeFrame: At Cycle 1, Day 29.
measure: The Percentage of Responders With Respect to the SGA Score at Cycle 1, Day 29 (DB Period).
timeFrame: At Cycle 1, Day 29.
Other outcomes:
measure: The Percentage of Responders Measured by the ILA at Maximum Frown at Cycle 1 Study Visits (DB Period).
timeFrame: Up to Cycle 1, Day 85.
measure: The Percentage of Responders Measured by the SSA at Maximum Frown at Cycle 1 Study Visits (DB Period).
timeFrame: Up to Cycle 1, Day 85.
measure: The Percentage of Responders Measured by the ILA at Rest at Cycle 1 Study Visits (DB Period).
timeFrame: Up to Cycle 1, Day 85.
measure: The Percentage of Responders With Respect to Independent Reviewer's Assessment of Photographs of the Subject's Glabellar Lines at Maximum Frown at Cycle 1, Day 85 (DB Period).
timeFrame: At Cycle 1, Day 85.
measure: Mean SGA Score at Cycle 1 Study Visits (DB Period).
timeFrame: Up to Cycle 1, Day 85.
measure: The Percentage of Responders With Respect to the SGA Score at Cycle 1 Study Visits (DB Period).
timeFrame: Up to Cycle 1, Day 85.
measure: Least Squares (LS) Mean Change From Baseline in Subject's Self-perception of Age at Cycle 1 Study Visits (DB Period).
timeFrame: Up to Cycle 1, Day 85.
measure: The Time to Onset of Treatment Response Based on the Subject's Diary Card (DB Period).
timeFrame: At Cycle 1, Day 8.
measure: The Percentage of Responders Measured by the ILA at Maximum Frown at All Other Study Visits (OL Period).
timeFrame: Up to Cycle 5, Day 85.
measure: The Percentage of Responders Measured by the SSA at Maximum Frown at All Other Study Visits (OL Period).
timeFrame: Up to Cycle 5, Day 85.
measure: The Percentage of Responders Measured by the ILA at Rest at All Study Visits (OL Period).
timeFrame: Up to Cycle 5, Day 85.
measure: Mean SGA Score at All Other Study Visits (OL Period).
timeFrame: Up to Cycle 5, Day 85.
measure: The Proportion of Responders With Respect to the SGA Score at All Other Study Visits (OL Period).
timeFrame: Up to Cycle 5, Day 85.
measure: Mean Change From Baseline in Subject's Self-Perception of Age at All Study Visits (OL Period)
timeFrame: Up to Cycle 5, Day 29.
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Air Force General Hospital, PLA
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Guanzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
city: Nanjing
country: China
facility: Dermatology Hospital of the Chinese Academy of Medical Sciences
city: Tianjing
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
Study officials:
affiliation: Ipsen
name: Ipsen Study Director, M.D.
role: STUDY_DIRECTOR
References: