Efficacy and safety of combined oral isotretinoin and desloratadine vs. isotretinoin alone in acne vulgaris: a comparative study

Abstract

A combination of desloratadine (DESL) and oral isotretinoin (ISO) may enhance efficacy and reduce the side effects of ISO, particularly those affecting the skin and mucous membranes. We compared the efficacy and safety of this combination versus ISO alone with new dose regimens in the treatment of patients with acne vulgaris. This was a double-blinded, randomized comparative study conducted on 64 patients with acne vulgaris. The severity of acne was scored according to the global acne grading system (GAGS). Serum lipid profile and liver function tests were evaluated before beginning the therapy and repeated monthly for 3 months. Exclusion criteria included hepatic, hyperlipidemic, pregnant, and lactating patients. The patients were divided into the following four groups, with each group including 16 patients treated daily for 3 months: Group I: received a high dose of ISO (0.5 mg/kg) combined with DESL (5 mg), Group II: received a low dose of ISO (0.25 mg/kg) combined with DESL (5 mg), Group III: received a high dose of ISO alone (0.5 mg/kg), and Group IV: received a low dose of ISO alone (0.25 mg/kg). Two patients, each from Group I and Group II, did not complete the treatment course. One patient, each from Group III and Group IV, dropped out of the study. A significant decrease was observed in the GAGS score post-treatment compared to pre-treatment in each group (p < 0.001). In addition, a decrease in the frequency of skin and mucus membrane side effects among Group II, and increased improvement in the GAGS score among Group I were noted; however, no significant differences were observed. Group IV patients were more safe for serum lipids and liver enzymes compared to other groups. Altogether, low-dose ISO, alone or in combination with DESL, is effective for acne vulgaris with fewer side effects compared to high-dose ISO regimens.