Efficacy of Isotretinoin and Antihistamine versus Isotretinoin Alone in the Treatment of Moderate to Severe Acne: A Randomised Control Trial
Abstract
Background Acne vulgaris has considerable impact on physical and psychological health. Isotretinoin is considered most effective drug available for acne therapy but with limited acceptance because of its adverse effects. Antihistamine inhibits inflammatory mediators, Propionibacterium acne induced itching, reduction of squalene and sebum in sebocyte, reduces anxiety and further lessens hormonal derangement and inhibits mast cell induced fibrosis and scars. Clinical relevance is lacking in the use of antihistamine in the treatment of acne and its potential efficacy needs to be clarified. Objective To evaluate the efficacy and safety of combining isotretinoin and antihistamine compare to isotretinoin alone in patients with moderate to severe acne at week 12. Method One hundred patients with moderate to severe acne were included in this randomised, controlled comparative study. Fifty patients were treated with isotretinoin and 50 patients were treated with additional antihistamine, levocetirizine and assessment was done at baseline, 4, 8 and 12 weeks of treatment. Result At week 12, compared to isotretinoin only group, combination of isotretinoin and levocetirizine group showed more statistically significant decrease in score of global acne grading system (51.0 vs. 38.5%) and acne lesion counts (non-inflammatory lesion: 63.2 vs. 44.5%; inflammatory lesions: 75.9 vs. 62.7%; total lesions: 66.07 vs. 48.7%; all p< 0.05). Flaring up of acne occurred less frequently and adverse…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.
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