A RATIONAL PHARMACOTHERAPEUTIC STUDY IN PHARMACOVIGILANCE: A COMPARATIVE ASSESSMENT OF SAFETY BETWEEN TOPICAL 1% NADIFLOXACIN AND 0.1% ADAPALENE COMBINATION THERAPY AND TOPICAL 1% NADIFLOXACIN AND 0.025% TRETINOIN COMBINATION THERAPY, IN MILD TO MODERATE ACNE, IN TERTIARY CARE HOSPITALS, IN INDIA

Abstract

Moumita Hazra

BACKGROUND Topical adapalene and tretinoin, are comedolytic, anti-comedogenic and anti-inflammatory, on RAR (α, β, ?) receptors binding. Due to higher chemical stability, lipophilicity and lesser photo-lability, adapalene enables quicker follicular penetration, by lesser anti-AP-1 (c-Jun, c-Fos) and no CRBPII mRNA action, thus producing lesser photosensitivity and no skin irritation, unlike tretinoin; in which, these are reducible by overnight application, combination therapy, slow-release polymers or emollients. Topical nadifloxacin is bactericidal, anti-inflammatory and comedolytic, with inhibitory effect on DNA gyrase, DNA topoisomerase IV and IL-1α, IL-6, IL-8. The Global Alliance to Improve Outcomes in Acne guidelines recommend synergistic and additive combination therapies, which enhance therapeutic efficacy and reduce adverse effects. Due to inadequacy of data, this study was conducted, to compare the safety between topical 1% nadifloxacin and 0.1% adapalene combination therapy and topical 1% nadifloxacin and 0.025% tretinoin combination therapy, in mild to moderate acne, in tertiary care hospitals, in India. METHODS Groups A and B (50 patients each), applied topical 1% nadifloxacin and 0.1% adapalene combination therapy and 1% nadifloxacin and 0.025% tretinoin combination therapy, respectively, over their mild to moderate facial acne lesions, once daily overnight; and adverse effects, like erythema, scaling, dryness, pruritus, burning or stinging, were assessed on 0, 15, 30, 60, 90 days and follow-ups, by Local Irritation Scale. This is a multi-centre, prospective, randomised, open-labelled, comparative, rational pharmacotherapeutic study. Data was statistically analysed, with the calculation of Z values and p values, along with the Z test for proportions. RESULTS In both groups, no adverse effects were observed, with no statistically significant difference among the observations. CONCLUSIONS The therapies were well tolerated and safe among both groups.

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