Effectiveness and Safety of Montelukast as an Adjuvant Therapy to Isotretinoin Treatment of Acne Vulgaris: A Randomized Controlled Trial

Introduction Isotretinoin effectively targets all acne-related pathological mechanisms but is associated with various side effects. On the other hand, montelukast serves as an antagonist to LB4, which is an important mediator in acne pathogenesis. Objectives This study aimed  to compare the efficacy of montelukast as an adjuvant treatment to isotretinoin versus isotretinoin alone for moderate acne vulgaris and to evaluate treatment tolerability by monitoring side effects. Materials and Methods A randomized comparative prospective trial included 40 patients from the Dermatology and Venereology Hospital at Damascus University. They were assigned into two groups: group A received montelukast (10mg/day) with isotretinoin (20 mg/day for 10 days, followed by 0.6 mg/kg/day for three months), while  group B received  isotretinoin alone (20 mg/day for 10 days, followed by 0.6 mg/kg/day for three months). Follow-ups occurred on the 40th  day and then monthly, assessing GAGS, comedones, inflammatory lesions, total lesions, and side effects at each visit. Additionally, patient satisfaction was assessed during the final visit. Results Adding montelukast to isotretinoin significantly reduced GAGS, comedones, inflammatory lesions, and total lesions, with statistically significant differences between the beginning and end of treatment. By evaluating patients at the end of treatment period, there were significant statistical differences between the two treatment groups regarding  GAGS, inflammatory lesions, total lesions, and patient satisfaction, with more side effects reported in the isotretinoin group. Conclusion Montelukast combined with isotretinoin is an effective treatment for moderate acne vulgaris, outperforming isotretinoin  alone with fewer side effects.