Kawashima 2017b.
Methods |
Study design: parallel design Duration of follow‐up: 12 weeks |
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Participants |
Total number of participants randomised: N = 609 Inclusion criteria
Exclusion criteria
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 |
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Interventions |
Interventions in Group A
Interventions in Group B
Interventions in Group C
Co‐interventions: not reported |
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Outcomes |
Primary outcomes of review interest
Secondary outcomes of review interest
Other outcomes reported in the study
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 |
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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 |
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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 |
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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 |