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

Lowe 2006.

Study characteristics
Methods Study design‐ single centre, double‐blind, randomised study, active‐controlled, parallel‐design
Study date‐ start (March 2003), end (March 2005)
Study setting‐ outpatients from one private clinic
Participants Randomised 62 participants, with mean age of 41 years (range 27‐60 years) total population; 44 ± 7.3 years in BontA1 group; 39 ± 6.6 years in BontA2 group.
Gender‐ 90% female, 10% male
Inclusion criteria
  • Moderate or severe glabellar lines at maximum contraction (graded by the investigator using a scale of none, mild, moderate, or severe) and were 18 to 55 years of age. Female patients of childbearing potential were required to have a negative urine pregnancy test result


Exclusion criteria
  • Any of the following reasons: facial cosmetic procedure planned during the study

  • Visible scars or prior cosmetic procedures that could interfere with the evaluation of response

  • Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen glabellar lines even by physically spreading them apart

  • Myasthenia gravis, Eaton‐Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuro‐ muscular function; use of an aminoglycoside antibiotic, curare‐like agent, or other agent that might interfere with neuromuscular function

  • Profound atrophy or excessive weakness of the muscles in the target injection areas

  • History of facial nerve palsy

  • Systemic infection or an infection at the injection site

  • Recent evidence of alcohol or drug abuse

  • Participation in an investigational drug study in the preceding 30 days

  • Treatment with any botulinum toxin serotype in the preceding 12 months


Severity of disease‐ moderate or severe glabellar lines at maximum contraction. BontA group comprised 15 of 31 patients (48%) with moderate glabellar lines and 16 patients (52%) with severe glabellar lines. In the BontA2 group, 17 of 31 patients (55%) had moderate glabellar lines and 14 (45%) had severe glabellar lines at baseline.
Ethnicity‐ 97% Caucasian
Interventions Duration of study‐ 16 weeks
Intervention
  • OnabotulinumtoxinA (20 U), 0.1mL/site, 5 points, one in the procerus muscle and two in each corrugator muscle (N = 31)


Comparator
  • AbobotulinumtoxinA (50 U), 0.1mL/site, 5 points, one in the procerus muscle and two in each corrugator muscle (N = 31)


Ratio‐ 1:2.5 (OnabotulinumtoxinA: AbobotulinumtoxinA)
Outcomes Primary outcome
  • Incidence of at least 1‐grade improvement in the severity of the glabellar lines evaluated by the investigator from photographs taken at week 16


Secondary outcomes
  • Incidence of patients whose glabellar line severity was graded as none or mild at maximum contraction

  • Incidence of relapse (return of glabellar line severity to baseline levels for two consecutive visits)

  • Patient satisfaction (7‐point)

  • Adverse events

Notes "Drs P. Lowe and R. Patnaik have received research grants from Allergan, Inc. Dr N. Lowe owns stock in Allergan, Inc, and has received research grants, consulting payments, and educational grants from Allergan, Inc. He has also received research grants and consulting payments from Medicis. Gill Shears, PhD (of Gill Shears, Inc), provided assistance with the writing of the manuscript."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "a computer‐generated randomisation code, in block sizes of 6, that determined treatment assignments for each individual. "Randomization cards" were prepared" page 976
Comment: we considered this low risk of bias
Allocation concealment (selection bias) Low risk Quote: "randomisation number and contained the treatment assignment. These were kept in a secure location and neither the investigator nor the patients had access to them or their contents. The treatment assigned to each patient was determined at the baseline visit by a pharmacist who opened the card with the lowest available randomisation number in order to discover the treatment assignment and then prepared the appropriate syringe" page 976
Comment: we considered this low risk of bias
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "The investigator and the patients were masked as to which product was being used—the syringes were identical in appearance and the volume to be injected was the same regardless of the product" page 976
Comment: we considered this low risk of bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "The investigator and the patients were masked as to which product was being used—the syringes were identical in appearance and the volume to be injected was the same regardless of the product." page 976
Comment: we considered this low risk of bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "A total of 62 patients were enrolled, of whom 59 (95%) completed the study (Fig 1). No patient discontinued because of lack of efficacy or adverse effects and one each discontinued for personal reasons, withdrawal of consent, and need for surgery." page 977
Comment: we considered this 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 Dr N. Lowe owns stock in Allergan, Inc.
Comment: we considered this unclear risk of bias