Study characteristics |
Methods |
Study design‐ randomised, first phase double‐blind, second phase open‐label, multicentre, active andpPlacebo‐controlled study. Phase III Study date‐ start December 2009, end August 2010 Study setting
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Participants |
520 participants, with a mean age raging from 18‐65 years. Gender: 86.8% (282/325) femal,13.2%, (9/325) male in Abobotulinumtoxin 50 U group, 86.4% (57/66) female, 13.6%, (9/66) male in Abobotulin placebo group, 87.9% (94/107) female, 12.1% (13/107) male in Onabotulinumtoxin 20u group, 86.4% (19/22) female, 13.6% (3/22) male in Onabotulintoxin ‐placebo group. Inclusion criteria
Provision of written informed consent
Male or female Chinese participants who are between 18 and 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, photo rejuvenation 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 participants who have any psychiatric illness or are taking antidepressant, anxiolytic or antipsychotic medication
Pregnant and/or lactating female participants
Female participants 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 participant is unable and/or unwilling to comply fully with the protocol and the study
Mental incapacity, unwillingness or language barriers
Ethnicity:100% Asian (Chinese) Country: China |
Interventions |
Intervention
AbobotulinumtoxinA, 50 U, divided into five injections into the glabellar area. Administered in double‐blind fashion at cycle 1 followed by up to 4 cycles AbobotulinumtoxinA, 50 U administered with an interval period depending on response, no less than 12 weeks between each treatment cycle
Comparator
OnabotulinumtoxinA will be administered in treatment cycle 1 only. On Day 1, 20 U, divided into five injections into the glabellar area
Saline solution 0.9% will be administered in treatment cycle 1 only. On Day 1, 20 U, divided into five injections into the glabellar area
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Outcomes |
Primary outcome
Secondary outcomes
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]
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Notes |
Sponsor Ipsen Other study ID Y‐52‐52120‐158. We sent an email on April,28,2019.The Ipsen company answered:"These trials have not been published unfortunately." on June, 27, 2019. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: No information Comment: we considered it unclear risk of bias |
Allocation concealment (selection bias) |
Unclear risk |
Quote:No information Comment: we considered it unclear risk of bias |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote:No information Comment: we considered it unclear risk of bias |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote:No information Comment: we considered it unclear risk of bias |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote:The authors described in the table reasons not complete the study Comment: we considered it low risk of bias |
Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes were reported Comment: we considered this low risk of bias |
Other bias |
Unclear risk |
This study was in clinical trial register site. We have contacted Ipsen pharmaceutical several times (last one January, 24, 2020) asking for publishing information. Answer‐ They did not have published it yet |