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. 2020 Mar 16;2020(3):CD011154. doi: 10.1002/14651858.CD011154.pub2

Kawashima 2017b.

Methods Study design: parallel design
Duration of follow‐up: 12 weeks
Participants Total number of participants randomised: N = 609
Inclusion criteria
  • Male and female outpatients aged 12 to 49 years

  • 11 to 40 inflammatory lesions, 20 to 100 non‐inflammatory lesions, and ≤ 2 nodules/cysts


Exclusion criteria
  • Pregnant, breastfeeding, or hoping to become pregnant

  • Fluctuation in acne symptoms with the menstrual cycle

  • Acne vulgaris, rosacea, or other skin disease

  • Using acne treatment within a specified period (specified as below)

  • Hypersensitivity or allergy to any component of study drugs

  • Serious complications (including systemic disease)


Sites of acne: face
Severity of acne and corresponding criteria of judgement: lesion count
Treatment before study: unclear
Participants' baseline data presented as mean (SD) for each group
Sex ratio (male/female): A = 84/119; B = 79/124; C = 91/110
Age (years): A = 19.5 (5.7); B = 20.0 (5.6); C = 19.2 (5.5)
Duration of acne (years): unclear
Interventions Interventions in Group A
  • Topical treatment: BPO

  • Regimen: leave‐on

  • Concentration: 2.5%

  • Vehicle: gel

  • Dose: once daily

  • Duration: 12 weeks

  • Number of participants assigned: 204


Interventions in Group B
  • Topical treatment: BPO

  • Regimen: leave‐on

  • Concentration: 5%

  • Vehicle: gel

  • Dose: once daily

  • Duration: 12 weeks

  • Number of participants assigned: 204


Interventions in Group C
  • Topical treatment: placebo

  • Regimen: leave‐on

  • Concentration: N/A

  • Vehicle: gel

  • Dose: once daily

  • Duration: 12 weeks

  • Number of participants assigned: 201


Co‐interventions: not reported
Outcomes Primary outcomes of review interest
  • Withdrawal due to adverse effects


Secondary outcomes of review interest
  • Investigator‐assessed change in lesion counts*

  • Percentage of participants experiencing any adverse event


Other outcomes reported in the study
  • Local skin tolerability scores on a 4‐grade scale (from 0 = none to 3 = severe)


Participants were evaluated at baseline and at weeks 2, 4, 6, 8, 10, and 12
*This outcome was assessed as the primary outcome in the trial
Study details Study period: February 2012 to October 2012
Country: Japan
Setting: unclear
Number of study centres: 30
Washout period: 12 weeks washout for systemic or topical retinoids, or systemic antibiotics; 4 weeks washout for chemical peeling, laser ray treatment, or systemic use of anti‐acne medications (excluding vitamins B2 and B6), steroids, or antibiotics; 2 weeks washout for topical use of anti‐acne medications (excluding vitamins B2 and B6), steroids, or antibiotics
Registered number: JapicCTI‐121784
ITT analysis: yes
Publication details Language of publication: English
Funding: unclear
Conflicts of interest: "Maruho Co. Ltd covered all expenses for this study. All drugs used for this study were provided by the company. M. K. was the medical advisor of the study and S. S., F. F., K. M., H. A., A. I., Y. T., N. H. and Y. Y. were coordinating investigators of the study. M. K. and Y. T. received fees for consultation, lectures and writing from the company. S. S .received fees for lectures and research grants from the company. A. I. received fees for consultation, lectures and writing, and research grants from the company. N. H. received fees for lectures and writing from the company. T. N. and T. K. are employees of the company"
Publication status: full article
Stated aim for study Quote from publication: "this study was a multicenter, placebo‐controlled, randomized, double‐blind, parallel‐group, comparative study to confirm the efficacy and safety of 2.5% and 5% BPO gel in Japanese patients with acne vulgaris and identify the recommended clinical dose of BPO"
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients who enrolled in this study were first treated with placebo during the 2‐week observation period, and then randomized (1:1:1) by a computer randomization system (six patients in each block) to receive BPO 2.5%, BPO 5% or placebo"
Comment: the method used to generate the random sequence was specified
Allocation concealment (selection bias) Unclear risk Comment: trial authors did not mention the method of allocation concealment used
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: trial authors mentioned that in this double‐blind trial, participants were blinded. However, it is unclear whether personnel were blinded. Complete blinding was difficult as treatment‐related adverse events were more common in the BPO groups
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: it is unclear whether outcome assessors were blinded. However, complete blinding was difficult as treatment‐related adverse events were more common in the BPO groups
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: more than 94% of participants in each group completed the trial
Selective reporting (reporting bias) Low risk Comment: all outcomes planned on the trial registry have been reported
Other bias Low risk Comment: as shown in Table 1, baseline demographic and disease characteristics of participants were similar between groups. Washout periods were long enough