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. 2021 Jul 5;2021(7):CD011301. doi: 10.1002/14651858.CD011301.pub2

NCT02450526.

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
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

Outcomes Primary outcome
  • 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
  • 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]

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