Efficacy Of Oral Isotretinoin With Levocetirizine Vs Oral Isotretinoin Monotherapy In Acne Vulgaris: A Randomised Controlled Trial

This randomized, assessor-blinded pilot trial compares oral isotretinoin plus levocetirizine versus isotretinoin alone in 60 adults with moderate to severe acne vulgaris to determine whether combination therapy offers superior clinical outcomes. Acne is a multifactorial inflammatory condition, and while isotretinoin is the gold standard, antihistamines may enhance its efficacy by reducing inflammation, itch, squalene and sebum levels, and scratching-related excoriation. Participants are randomised into two groups, assessed at baseline and then every four weeks for 12 weeks using GAGS, VAS, DLQI, and adverse event monitoring. The study hypothesizes that adding levocetirizine will lead to greater reductions in acne severity and improved quality of life. Statistical analysis will use t-tests, Mann-Whitney tests, and correlation methods through SPSS v26.0 to compare outcomes between groups. The expected conclusion is that the combination regimen will outperform isotretinoin monotherapy in both efficacy and symptomatic relief.