Background: Acne vulgaris is a chronic inflammatory disease. The multifactorial etiology of acne vulgaris makes it challenging to treat.\r\nAntimicrobials should be combined with topical retinoids for greater clearing of lesions and shortened duration of antibiotic treatment.\r\nAim: The present study compared the efficacy and safety of nadifloxacin and adapalene fixed dose combination (FDC) gel with adapalene\r\nmonotherapy and nadifloxacin monotherapy.\r\nMethod: It was a randomized, double blind, controlled, multicentre, phase III, parallel group study conducted in India. In this eightweek\r\nstudy, 318 patients with mild to moderate acne were randomly allocated to either of the three treatment groups; Group A (morning\r\nplacebo, evening FDC; FDC of nadifloxacin 1% + adapalene 0.1%, n=106), Group B (morning placebo, evening adapalene 0.1%,\r\nn=106) and Group C (twice daily nadifloxacin 1% alone, n=106). The outcome variables included lesion counts, acne severity based\r\non investigator global assessment (IGA) scale and quality of life (QOL) assessment. Adverse events (AEs) were recorded at every visit.\r\nFindings: At the end of the treatment, maximum mean reduction in inflammatory lesion counts were comparable in Group A (-11.1) in\r\ncomparison to Group B (-8.9) and Group C (-8.5); p>0.05 for both. However, change from baseline in non-inflammatory lesion count at\r\nweek eight was higher in Group A (-13.1) compared to Group B (-12.0); p=0.04 and Group C (-11.5), p =0.17. For acne severity, 61.7%\r\nof patients in Group A, 54.3% in Group B and 56% in Group C showed improvement. The maximum improvement in terms of quality\r\nof life (QOL) score was observed in Group A; with comparable results for the other group.\r\nConclusion: Topical fixed dose combination of nadifloxacin 1% and adapalene 0.1% is effective in mild to moderate acne with good\r\ntolerability.
