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. 2020 May 1;2020(5):CD011368. doi: 10.1002/14651858.CD011368.pub2

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
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
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
Outcomes Primary outcomes
  • Participants' global self‐assessment of acne improvement (e.g. measured by a 4‐point scale: excellent, good, fair, and poor). Authors did not report this outcome

  • Withdrawal for any reason. No withdrawals


Secondary outcomes
  • Change in lesion counts (total or inflamed and non‐inflamed separately). Percentage reduction of total lesions, week 16, SDs were missing

  • Physicians' global evaluation of acne improvement. Authors did not report this outcome

  • Minor adverse events (assessed as total number of participants who experienced at least one minor adverse event). Only mentioned 'drying of lips', no usable data

  • Quality of life. Authors did not report this outcome


Other outcomes that were not analysed in this review
  • MAS

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