© 2009 The Authors JEADV 2009, 23, 556–560 Journal compilation © 2009 European Academy of Dermatology and Venereology DOI: 10.1111/j.1468-3083.2008.03022.x JEADV Blackwell Publishing Ltd ORIGINAL ARTICLE Efficacy of fixed low-dose isotretinoin (20 mg, alternate days) with topical clindamycin gel in moderately severe acne vulgaris K Sardana,* † VK Garg, † VN Sehgal, ‡ S Mahajan, § P Bhushan § † Department of Dermatology and STD, Maulana Azad Medical College and Lok Nayak Hospital Delhi, ‡ Dermato-Venereology (Skin/VD) Centre, Sehgal Nursing Home, Delhi, § Department of Dermatology and STD, Lady Hardinge Medical college, Delhi *Correspondence: K Sardana. E-mail: kabirijdvl@gmail.com Abstract Background In view of the potentially serious side-effects of standard isotretinoin (0.5–1.0 mg/kg per day) therapy for acne, we studied the safety and efficacy of low-fixed dose isotretinoin plus topical 1%clindamycin gel in the treatment of moderate grade of acne. Methods In this prospective, non-comparative study, 320 adult patients, with moderately severe acne were enrolled and treated with fixed-dose isotretinoin at 20 mg every alternate day (approximately 0.15 mg/kg/day to 0.28 mg/kg/day) for 6 months along with topical clindamycin gel. All female patients were assessed for polycystic ovarian disease. Patients were followed up for 6 months. Results A total of 305 patients completed the study. Overall, patients received a mean of 38.4 mg/kg cumulative dose of isotretinoin, and very good results were observed in 208 (68.20%), while good response was seen in 59 (19.34%) of patients. Failure of the treatment occurred in 38 (12.46%), while relapses occurred in 50 (16.39%) of patients. Relapses were commoner in females, and 37 of 43 (86.04%) patients had polycystic ovarian disease. Though mild chelitis (91%) and xerosis (43%) were common, laboratory abnormalities in the form of elevated hepatic enzymes (5%) and elevated serum lipids (6%) were rare. Conclusion Six months of treatment with fixed-dose, alternate-day isotretinoin (20 mg) plus topical 1%clindamycin gel was found to be effective in the treatment of moderate acne in adult patients, with a low incidence of side-effects. Received: 15 July 2008; Accepted 1 October 2008 Keywords acne, clindamycin, isotretinoin, low dose Conflicts of interest None declared Introduction The advent of isotretinoin has been a turning point in the treatment of acne vulgaris. It was initially used for severe cases of nodulocystic but now it is used as an off-label indication for moderate acne. Its conventional recommended dose has been 0.5–1.0 mg/kg body weight per day for 16–32 weeks, with a maximum cumulative dose of 120 mg/kg. 1–3 The regimen is known to produce good results; however, it might cause several dose dependent side-effects. In an endeavor to surmount this limitation, low-dose regimens for moderate grades of acne have been advocated through the recent studies. 4–9 We formulated a study of low-dose regimen of isotretinoin with topical clindamycin in a combination that has not been tried in a hospital setting. Methods An open, prospective, non-comparative study consisting of 320 patients with moderate papulopustular acne was designed. The subjects had predominantly facial involvement. (260 facial, 60 facial and truncal) They were treated for a period of 6 months and were followed up for another 6 months period. Of the 320, 4 patients dropped out, while 11 patients could not be followed. The assessment of the acne was done according to the criteria based on International consensus guideline. 2 The untreated patients of acne vulgaris were taken into confidence and examined in privacy under good illumination by a dermatologist. Patients were finally graded on basis of severity as described by Pochi et al. 2 into mild, moderate and severe. In order to enable analysis of improvement in lesion count, total acne load was calculated