Comparing the efficacy of oral isotretinoin alone and in combination with desloratadine in treating moderate to severe acne vulgaris: a randomized clinical trial

Isotretinoin is the primary treatment for moderate to severe acne vulgaris. Recently, combining an antihistamine with this medication has received attention. Researchers investigated the presence of H1 receptors and evaluated the impact of antihistamines on cellular squalene levels. They investigated how antihistamines affected cultured sebocytes and discovered that these medications were efficient anti-inflammatory agents that reduced lipogenesis in sebocytes. This study aimed to compare the effectiveness and safety of combination therapy with isotretinoin and desloratadine to isotretinoin alone for treating acne. In this randomized clinical trial, 60 patients with moderate to severe acne vulgaris were randomly assigned to receive either 20 mg of isotretinoin alone every other day (group 1) or combination therapy including isotretinoin (20 mg/ every other day) and desloratadine (5 mg/ every day) (group 2) for 6 months. A t-test was used to examine and compare the improvement in acne severity (GAGS Score), which was assessed by a blinded dermatologist, and side effects before and 24 weeks after treatment. The study included 56 patients. The mean GAGS Score (Acne Severity) for groups 1 and 2 was 24.93 ± 6.19 and 25.04 ± 5.39, respectively (P = 0.945). After 6 months of treatment, it decreased to 7.00 ± 2.76 in group 1 versus 4.85 ± 3.15 in group 2 (P = 0.019). The trend of changes in GAGS score was significantly different between the two treatment regimens (P = 0.006). Dermatologists observed no significant difference in improvement rates between the two groups after 6 months of therapy (88.36% versus 90.31%; P = 0.609). Regarding side effects, there was a significant difference between the two groups after 6 months (P = 0.05). Adding desloratadine to isotretinoin was a more effective and safer therapeutic approach in treating acne vulgaris than isotretinoin alone, resulting in a more significant reduction in acne severity.