Resumo

Objectives: We aim to study the efficacy of Pirfenidone 8% gel+ILS when compared to ILS monotherapy. Introduction: Keloids are difficult to treat, recur, cause discomfort to patients. Many treatment options are available, yet optimum results hard to predict. Intralesional steroid(ILS) is commonly used but comes with many side-effects. Pirfenidone is an anti-fibrotic agent causing TGF-β1 pathway suppression, available in a novel 8% gel form that may enhance keloid treatment response. Materials / method: Open label randomised clinical trial conducted comparing ILS(GroupA) vs ILS+Pirfenidone(GroupB) among patients aged 18-70y/o, not previously treated, after informed consent, post ethics approval. Sample size, 36 patients each. Patients followed up at baseline,3,6,9,12 weeks, measuring modified Vancouver Scar Scale(mVSS) for keloids. Results: Demographic, clinical characteristics in both the groups were comparable, mean age (Gr.A: 32.44 & Gr.B: 30.78 in years), Gender distribution (Male: Female Gr.A: 5:4 & Gr.B: 4:5) as well as mean (± SD) baseline mVSS (Gr.A: 9.28± 2.94 vs Gr.B: 9.78± 3.16). 12 weeks after interventions, independently in both arms, there was significant improvement of mVSS compared to baseline (Mean ± SD Gr.A : 5.69± 2.28 vs 9.28± 2.94; Gr.B: 5.06± 2.35 vs 9.78± 3.16). At 12 weeks Repeated Measures ANNOVA outcomes after greenhouse-Geisser correction (Ɛ= 0.480): F(1.92,134.45)= 199.22, p= 0.001, ƞ2p= 0.740. Conclusion: Hence, we conclude that ILS+Pirfenidone(Group B) showed improvement over ILS(Group A) treatment group.