Papageorgiou 2000.
Methods |
Study design: parallel design Duration of follow‐up: 8 weeks |
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Participants |
Total number of participants randomised: N = 45 Inclusion criteria: grade I acne severity and ≥ 5 inflammatory lesions Exclusion criteria
Sites of acne: face Severity of acne and corresponding criteria of judgement: unclear Treatment before study: unclear Participants' baseline data presented as mean (SD) for each group Sex ratio (male/female): A = 4/9; B = 3/10; C = 4/11 Age (years): A = 29.5 (range 19 to 50); B = 26.2 (range 14 to 43); C = 27.5 (range 14 to 50) Duration of acne (year): unclear |
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Interventions |
Interventions in Group A
Interventions in Group B
Interventions in Group C
Co‐interventions: none |
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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 4 and 8 weeks of treatment *This outcome was assessed as the primary outcome in the trial |
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Study details |
Study period: unclear Country: unclear Setting: unclear Number of study centres: multiple but unclear Washout period: 2 weeks washout for any systemic or topical acne therapy Registered number: unclear ITT analysis: no |
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Publication details |
Language of publication: English Funding: unclear Conflicts of interest: not specified Publication status: full article |
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Stated aim for study | Quote from publication: "the purpose of this trial was to evaluate this new product and compare its efficacy and safety with a more traditional acne therapy, 5% benzoyl peroxide cream" | |
Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: no information on the method used to generate the random sequence was provided |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information about allocation concealment was provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "this trial was a double‐blind controlled randomized parallel group comparison..." Comment: who was blinded remains unclear. However, complete blinding was difficult as treatment‐related adverse events were more common in the BPO group |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "this trial was a double‐blind controlled randomized parallel group comparison..." Comment: who was blinded remains unclear. However, complete blinding was difficult as treatment‐related adverse events were more common in the BPO group |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "four patients either voluntarily left the study or were lost to follow‐up" Comment: numbers of and reasons for withdrawal for each group were unclear |
Selective reporting (reporting bias) | Unclear risk | Comment: although all outcomes listed in the methods section were reported, we could not identify the corresponding protocol nor relevant information on a trial registry to confirm that selective reporting was avoided |
Other bias | High risk | Quote: "the three groups were well matched in terms of number of patients, age, sex distribution and severity of acne (Table 1)" Comment: baseline characteristics were similar between groups. The washout period for systemic acne treatments was not long enough |