Kar 2013.
Study characteristics | ||
Methods |
Aim of study: to compare the efficacy of oral isotretinoin and oral isotretinoin with 20% SA peels in participants with moderate to severe acne Design: parallel Unit of allocation: patients Allocation: unclear Blinding: investigator‐blinded Duration of trial (from recruitment to last follow‐up): carried out between April 2012 and March 2013 Dropouts: no |
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Participants |
Population description: moderate to severe acne Setting: Department of Skin and VD of a Tertiary Care Hospital of Eastern India Randomised number: 60 Age: range 18 to 25 years; mean ± SD 20 ± 1.9 years in combination group; 20.6 ± 1.9 years in isotretinoin group Sex: 16/14 in combination group; 13/17 in isotretinoin group Severity of illness: moderate to severe MAS score 64.1 ± 4.4 in combination group; 63 ± 5.1 in isotretinoin group |
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Interventions |
Name of treatment group: salicyclic acid and isotretinoin group; n = 30 Description: 20 mg oral isotretinoin once daily along with 20% SA peels every two weeks Treatment period: 16 weeks Timing: 20 mg oral isotretinoin once daily along with 20% SA peels every two weeks Name of treatment group: Isotretinoin group; n = 30 Description: 20 mg oral isotretinoin Treatment period: 16 weeks Timing: once daily |
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Outcomes |
Primary outcomes
Secondary outcomes
Other outcomes that were not analysed in this review
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Notes | Funding: SA peel (Vedasol ‐ 20 gel from Vedaderm Inc. Chicago) used in this study was supplied by Percos India. Isotretinoin (Cap Tretiva 20 mg) was supplied by Intas Pharmaceuticals bearing lot number S12B018 and expiry date January 2014 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomised using a random number table." Comment: random number table is reliable for random sequence generation |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Investigator 1 (1st author) did the group allocation of the patients using a random number table. Investigator 2 (2nd author) performed the chemical peeling on patients in the second group using 20% SA." Comment: blinding of participants probably insufficient |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The 3rd investigator (3rd author) was blinded from the group allocation and treatment modalities. She did the MASI scoring and evaluation of all patients at all the visits." Comment: binding of investigator probably sufficient |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the study, no missing outcome data |
Selective reporting (reporting bias) | Low risk | Results reported for all prespecified outcomes in the methods section |
Other bias | Low risk | No other potential bias identified |