A randomised, double blind, comparative clinical trial assessing the effectiveness and safety of dapsone 5% versus clindamycin 1% in the treatment of mild to moderate acne vulgaris

Introduction: Acne vulgaris is a common dermatosis ofadolescence having an impact on quality of life and social functioning.Clindamycin 1% is used for acne because of its activity against Propionibacteriumacnes. Dapsone 5% gel has recently got FDA approval for ACNE management.

Aims and objectives: Toevaluate the effectiveness and safety of Dapsone 5% and Clindamycin 1% in treatmentof mild to moderate acne vulgaris.

Methods: Theinstitution based randomised control trial was approved by institutional ethicscommittee and patients with mild to moderate acne (total lesions ≥ 2 but ≤ 30) were recruited after obtaining informedconsent and wererandomized(balanced un-stratified randomization; allocation ratio1:1;allocation concealment by SNOSE) into two groups(group A clindamycin; group B dapsone)respectively and twice dailytopical application was given  for atotal duration of 3 months with monthly follow up. Calculated sample size was56 with 5% alpha error, 80% power and 10% drop-out.

Result:  Amongst 51 patients completing the modifiedintention-to-treat protocol, 24 received clindamycin 1% (mean age 21.37± 4.65years) and 27 received 5 %dapsone (mean age 20.96± 4.73years). Significant reductionin acne-global-assessment scale was obtained with both dapsone 5% (Friedman’sANOVA P<0.001) and Clindamycin 1%(Friedman’s ANOVA P=0.001) but thesignificant reduction (P<0.05 Posthoc Dunn’s test) started from 1st follow-up with dapsone5% but from2nd follow-up with Clindamycin1%. Intergroup comparison ofacne-global-assessment scale showed no significant difference (P>0.05, Mann-Whitney test) atbaseline or any other follow-up visits. Similar result was obtained with numberof inflammatory and non-inflammatory lesions. Quality of life (DLQI) improvedin both treatment arm (P<0.05,Wilcoxon’s test). Adverse effect (burning, itching, irritation) weresignificantly more with Dapsone5% (P value= 0.007, chi square test) at 1stfollow up but became comparable at 2nd and 3rd follow-upvisits.

**Conclusions:**Dapsone5% is a promising medication in the treatment of mild-to-moderate acnevulgaris which shows improvement from 1st month onward, in contrastto Clindamycin1% where results are seen from 2nd month onward.Burning, Itching and irritation can occur in the 1st month withDapsone1% which resolves later.

Conflictof Interest: Nil