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1 International Journal of Universal Pharmacy and Life Sciences 2(2): March-April 2012 INTERNATIONAL JOURNAL OF UNIVERSAL PHARMACY AND LIFE SCIENCES Medical Sciences Original Article!!! Received: ; Accepted: TOPICAL DAPSONE: A NOVEL APPROACH IN ACNE VULGARIS Dr B.M Shashikumar 1 *, Dr M.R.Harish 1, Dr N.S.Shashi Kumar 2 1. Department of Dermatology, Mandya Institute of Medical Sciences, Mandya, Karnataka, India 2. Department of Pharmacology, Mandya Institute of Medical Sciences, Mandya, Karnataka, India Keywords: Acne vulgaris, dapsone gel, safety and efficacy For Correspondence: Dr B.M.Shashi Kumar Department of Dermatology, Mandya Institute of Medical Sciences, Mandya, Karnataka, India ABSTRACT Introduction: Acne vulgaris is a common skin disease that affects 83 95% of people at sometime during their lives. Most cases of acne vulgaris can be successfully treated by topical antibiotics. DDS (Dapsone), is a potent antibiotic with anti-inflammatory activity and demonstrated promising results in clearing both inflammatory and non-inflammatory acne lesions and also showed good safety profile even in G6PD deficiency patients. We evaluated the safety and efficacy of topical 5% dapsone gel on acne patients. Materials and methods: This is an open, non-comparative study of 6 weeks duration. 160 acne vulgaris patients were included and prescribed to apply a thin layer of Dapsone gel 5% over the affected area twice daily for 6 weeks. Results: Assessment was done as per the parameters of efficacy, safety and patients satisfaction and scored from A Score of was taken as excellent, good, fair and 1-24 taken as poor score. At the end of 6 weeks of therapy, among Grade1 (40), 8(20%) showed excellent response, 20(50%) good response, 9(22.5%) fair response and 3(7.5%) poor response. Among Grade 2 (40), 15(37.5%) showed excellent response, 20(50%) good response, 4(10%) fair response and 1(2.5%) poor response. Grade 3 (40), 10(25%) showed excellent response, 19(47.5%) good response, 9(22.5%) fair response, 2(5%) poor response. Grade 4 (40), 5(12.5%) showed good response, 4(10%) fair response and rest poor response. Conclusion: Topical dapsone 5% gel is highly effective and safe option in the management of mild to moderate acne. 74 Full Text Available On

2 INTRODUCTION Acne is an extremely common condition with complex pathogenetic factors involving defects in epidermal keratinization, androgen secretion, sebaceous function, bacterial growth, inflammation, and immunity. 1 Acne vulgaris is commonly seen in adolescence, characterized by papules and pustules (inflammatory lesions), and open and closed comedones (non-inflammatory lesions). The prevalence of acne increases through adolescence, affecting 39% of people at the age of 12 and 86% at age 17; nearly half of boys and one third of girls experience moderate to severe facial acne with extensive inflammatory lesions. 2 Dapsone is a sulfone administered orally for the treatment of certain skin diseases like leprosy, dermatitis herpetiformis etc. It has both antimicrobial and anti-inflammatory properties. 3,4 Antimicrobial activity of dapsone is similar to that of sulfonamides. Anti-inflammatory properties of dapsone exhibited in vitro include inhibition of neutrophil myeloperoxidase and eosinophil peroxidase, and suppression of hypochlorous acid production. 3,5,6 Dapsone also scavenges reactive oxygen in vitro, which may minimize the inflammation associated with the generation of these highly reactive species. 7 Orally dapsone is effective in the treatment of severe, nodulocystic inflamed acne 8,9 hematological and other complications limits its use on routine use. Topical dapsone is an alternative and showed good safety profile even in G6PD deficiency patients. 10,11 We evaluated the safety and efficacy of topical 5% dapsone gel on acne patients. MATERIALS AND METHODS It is a 6 weeks open-label, non-comparative study. A total of 160 patients were selected and 4 groups of 40 patients each were grouped and graded based on the global Acne Assessment Score of 5 point scale (Table-1). Table 1: Global Acne Assessment Score 0 None No evidence of facial acne vulgaris I Minimal Few non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) may be present II Mild Several to many non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present III Moderate Many non-inflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed IV Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present 75 Full Text Available On but

3 All patients with various grades of acne aged 12 years and above were included in the study. Patients with known hypersensitivity to Dapsone or sulfone group of antibiotics, Glucose 6 phosphate dehydrogenase deficiency, Pregnant or lactating women were excluded from the study. Patient who received systemic antibiotics within 4 weeks and oral isotretinoin within 12weeks prior to the study were excluded. Written informed consent was obtained from all patients prior to study enrollment. The patients were instructed to apply dapsone gel twice daily over the lesions for 6weeks. Concomitant prescription of cosmetics and other antibiotics was permitted based on the clinical judgment of the investigator. Assessment of efficacy and safety was conducted at the end of 2, 4 and 6 weeks. Assessment was done as per the parameters of efficacy, safety, and patient s satisfaction and scored from >75% = Excellent response. 50%-75% = Good response. 25%-49% = Fair response. <25% = Poor response Any adverse event reported by the patient or observed by the investigator, regardless of its relationship to the study drug, was noted in the case record form. No formal hypothesis testing was done for this study. The data has been presented descriptively. RESULTS A total of 160 cases attending Dermatology out-patient department were included which comprises of 82 Females and 78 Males. Mean age of patient was 28 years (youngest 14 years and oldest 42 years). All the patients completed the study. Efficacy: The percentage of patients showing an improvement in their disease increased at each evaluation time-point. At the end of 6 weeks (Table 2), Table 2: Evaluation of efficiency Response Grad I Grade II Grade III Grade IV Total Excellent 8(20%) 15(37.5%) 10(25%) 0 33(20.6) Good 20(50%) 20(50%) 19(47.5%) 5(12.5%) 64(40%) Fair 9(22.5%) 4(10%) 9(22.5%) 4(10%) 26(16.3%) Poor 3(7.5%) 1(2.5%) 2(5%) 31(77.5%) 37(23.1%) 76 Full Text Available On

4 8(20%) among 40 grade I acne patients showed excellent response, 20(50%) showed good response, 9(22.5%) had fair response and 3(7.5%) had poor response. Among Grade 2 (40), 15(37.5%) showed excellent response, 20(50%) good response, 4(10%) fair response and 1(2.5%) poor response. Grade 3 (40), 10(25%) showed excellent response, 19(47.5%) good response, 9(22.5%) fair response, 2(5%) poor response. Grade 4 (40), 5(12.5%) showed good response, 4(10%) fair response and rest poor response. A total of 20.6% patients showed an excellent response except in grade 4 patients. Overall response to dapsone, Good response was seen in 40% of patients but 60.6% of patients showed excellent to good response and 16.2% of patients showed Fair response. But only 7.2 % had poor response. Also, response was poor (77.7%) among grade IV acne. Tolerability: Tolerability to the dapsone gel as per the patient at the end of 6 weeks was rated as either excellent or good by 96% of the patients. Adverse effect: 6(3.8%) among 160 patients had mild adverse effect on the application site. 3 patient complained itching, 2 complained burning sensation and one had redness at the application site. In all of them, adverse events did not interfere with completion of treatment. DISCUSSION Acne vulgaris is a multifactorial disease in which diphtheroid Propionibacterium acne plays an important role in genesis of inflammation. 12 Antibiotic therapy directed against it has been one of the mainstays of treatment. 13 Though systemic antibiotics have been employed for years, during last decade topical antibiotics have become more acceptable for treating acne, because they have fewer side effects than oral antibiotics. A number of topical antibiotics have been tried in acne vulgaris but drug resistance is the main concern in long term treatment along with safety. The development of new antibiotics is promising and topical dapsone has shown good efficacy and safety. A dapsone can be safely combined with adapelene and benzyl peroxide in the management of acne. 14 In this study, 60.6% showed excellent to good response with topical dapsone gel where as in a study by Raimer 15 it was 40.1%. Similarly lucky 16 demonstrated 30.6% mean reduction in inflammatory lesion counts at 4weeks and response was better at the end of 12weeks with mean acne reduction of 58.2%, 19.5%, and 49.0% for inflammatory, noninflammatory, and total lesion counts respectably which was similar to the present study. 77 Full Text Available On

5 The overall incidence of application site reactions reported in this study was 3.8% which conforms to the 2-8.2% 11,15,16 incidence of adverse events as mentioned in various studies. Most of these adverse effects were mild. Common non-application site adverse events included headache and nasopharyngitis in many studies 11,15,16 but it is very significant to note that none of the patient in this study had non-application site adverse events. Also no significant changes in hematology or blood chemistry parameters were observed. This study has clearly demonstrated good efficacy, safety and tolerability of dapsone gel in the Indian skin type. The high efficacy of dapsone and compatibility with other concurrent acne medications makes topical dapsone a key component in the treatment of acne. REFERENCES 1. Webster GF. Overview of the Pathogenesis of Acne. In: Webster GF, Rawlings AV Acne and its therapy. Informa Healthcare USA 2007; Roberts J, Ludford J. Skin conditions of youths. Vital Health Stat ;157: Zhu YI, Stiller MJ. Dapsone and sulfones in dermatology: overview and update. J Am Acad Dermatol. 2001;45: Dapsone [package insert]. Princeton, NJ: Jacobus Pharmaceutical Co, Inc; Kazmierowski JA, Ross JE, Peizner DS, Wuepper KD. Dermatitis herpetiformis: effects of sulfones and sulfonamides on neutrophil myeloperoxidase-mediated iodination and cytotoxicity. J Clin Immunol. 1984;4: Bozeman PM, Learn DB, Inhibition of the human leukocyte enzymes myeloperoxidase and eosinophil peroxidase by dapsone. Biochem Pharmacol. 1992;44: Wozel G, Barth J. Current aspects of modes of action of dapsone. Intl J Dermatol. 1988;27: Kaminsky A. Less Common Methods to Treat Acne. Dermatology. 2003;206: Ross CM. The treatment of acne vulgaris with dapsone. Br J Dermatol 1961;73: Stotland M, Shalita AR, Kissling RF. Dapsone 5% gel: a review of its efficacy and safety in the treatment of acne vulgaris. Am J Clin Dermatol. 2009;10: Draelos ZD, Carter E, Maloney JM, Elewski B, Poulin Y, Lynde C, Garrett S; Two randomized studies demonstrate the efficacy and safety of dapsone gel, 5% for the treatment of acne vulgaris. J Am Acad Dermatol.2007;56:439.e Full Text Available On

6 12. Leyden JJ, Webster GF, Mills OH, Kligman AM. Propionibacterium acnes resistance to antibiotics in acne patients. Journal of the American Acade. 1983;8: Eady EA, Gloor M, Leyden JJ. Propionibacterium acnes resistance: a worldwide problem. Dermatology. 2003;206: Fleischer AB, Shalita A, Eichenfield LF, et al. Dapsone gel 5% in combination with adapalene gel 0.1%, benzoyl peroxide gel 4% or moisturizer for the treatment of acne vulgaris: A 12-week, randomized, double-blind trial. J Drugs Dermatol. 2010;9: Raimer S, Maloney JM, Bourcier M, Wilson D, Papp K, Siegfried E et al. Efficacy and safety of dapsone gel 5% for the treatment of acne vulgaris in adolescents. Cutis. 2008;81: Lucky AW, Maloney JM, Roberts J, Taylor S, Dapsone gel 5% for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment.j Drugs Dermatol. 2007;6: Full Text Available On

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