A randomized, open label, prospective study to compare efficacy and safety of oral isotretinoin with adjunctive montelukast versus isotretinoin alone in patients with moderate to severe grade acne

This study will be conducted in the Department of Pharmacology in collaboration with Department of Dermatology, Uttar Pradesh University Of Medical Sciences, Saifai, Etawah. The study will be completed in 12 weeks. Consent will be taken from each patient for baseline patient information, including a colour photo of the lesion area, during the initial visit. There will be a physician assessment on initial visit that includes grading of lesions based on two scales (Total Lesion Count and Global Acne Grade Scale) and blood test (CBC, LFT), random blood sugar. Then, using the odd even technique, they will be randomly allocated to either group, A or B for a duration of 12 weeks.

Group A will receive isotretinoin 0.5 mg/kg/day along with montelukast 10 mg once daily. Group B will receive isotretinoin 0.5 mg/kg/day alone. When the patient steps out the house, it will also be advised that they use lipid-free sunscreen with an SPF above 30. The patient will be checked on every four weeks. The patient will be monitored to see whether the symptoms may return after ceasing medication after the 12-week mark, which will include a review of the Isotretinoin vs Isotretinoin with Montelukast treatment groups.