Dapsone Gel in the Treatment of Papulopustular Rosacea: A Double-Blind Randomized Clinical Trial
June 2015 | Volume 14 | Issue 6 | Original Article | 602 | Copyright © 2015
Gita Faghihi MD,a Parastoo Khosravani MD,a Mohammad Ali Nilforoushzadeh MD,a,b Sayyed Mohsen
Hosseini PhD,a Fatemeh Assaf MD,a Naser Zeinali MD,a and Abbas Smiley MD MScc
aDepartment of Dermatology, Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
bSkin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran
cPoursina Clinic, Isfahan, Iran; Department of Epidemiology, Isfahan University of Medical Sciences, Isfahan, Iran
BACKGROUND: We aimed to evaluate the effects of 5% dapsone gel compared with 0.75% metronidazole gel in the treatment of papulopustular rosacea.
METHODS: In a double-blind randomized clinical trial, 56 adult patients with papulopustular rosacea were enrolled. The severity of disorder was determined by the patient according to visual analogue score (VAS). Investigator’s global assessment (IGA) scores and number of inflammatory lesions were recorded. 5% dapsone gel was administered for group D and 0.75% metronidazole gel was administered for group M. Systemic doxycycline was administered for all patients. Follow-up assessments were done at 4, 8, and 12 weeks. Changes in VAS, IGA scores and number of lesions were evaluated. Intention to treat analysis was carried out using SPSS version 17 (Chicago, IL).
RESULTS: There was no significant difference in sex and age distribution between the two groups. Mean (SD) IGA score before and after intervention in group D was 3.9 (0.9) and 3.3 (0.9), respectively (P<0.0001). Mean (SD) IGA score before and after intervention in group M was 4.2 (1.2) and 3.6 (1.3), respectively (P<0.0001). Mean (SD) number of lesions before and after intervention in group D was 15 (7.4) and 11.1 (6), respectively (P<0.0001). Mean (SD) number of lesions before and after intervention in group M was 17.6 (7.7) and 12.5 (7.4), respectively (P<0.0001). Mean (SD) VAS score before and after intervention in group D was 6.6 (1.8) and 5.7 (1.9), respectively (P<0.0001). Mean (SD) VAS score before and after intervention in group M was 6.9 (2.0) and 5.3 (2.1), respectively (P<0.0001). Mean IGA score, mean number of lesions and mean VAS score were not significantly different between the two groups, whether before, during or after intervention.
CONCLUSION: Dapsone gel was as effective as metronidazole gel in the treatment of papulopustular rosacea.
J Drugs Dermatol. 2015;14(6):602-606.
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Recurrent central and symmetric facial erythema, inflammatory pustules, and/or papules are characteristic features of papulopustular rosacea. Lack of comedones distinguishes the disorder from acne vulgaris.1-4 Women of middle age are more at risk of developing papulopustular rosacea.5 Rosacea affects about 14 million Americans.6 Although inflammation plays the major role in development of the disorder, its full pathogenesis is poorly understood.7-11 This makes the treatment more difficult. Long-term treatments and multiple simultaneous interventions are usually necessary. Primarily, management includes avoidance of triggers and application of topical medications such as metronidazole, azelaic acid or sodium sulfacetamide-sulfur with or with no oral antibiotics. The principal triggers are spicy foods, alcohol and flush-inducing medications. The main effective oral antibiotics include tetracycline, minocycline or doxycycline.12-17 They inhibit inflammatory mediators, pathways and mechanisms associated with rosacea such as fibroblast growth factor, matrix metalloproteinases, cytokines, nitric oxide, reactive oxygen species, granuloma formation, and angiogenesis.7-11 Papulopustular rosacea leads to lower self-esteem and self-confidence in approximately 70% of patients. The severe form of disorder ends to adverse professional interactions in around 70% of patients. About a third of the latter group may miss their jobs.18-20 Because of its common prevalence, chronicity, and its significant impact on quality of life, and since there is no curative treatment for papulopustular rosacea, the searches for appropriate cure are continued.21-25 Many topical medications such as sodium sulfacetamide-sulfur, metronidazole and azelaic acid have been evaluated.26-28 Successful effectiveness of dapsone in treatment of some skin disorders including granulomatous rosacea has been shown.29 No study was found on Pubmed search that investigated the effects of topical dapsone on papulopustular rosacea. The aim of this study was to measure the clinical efficacy of 5% dapsone gel compared with 0.75% metronidazole gel in the treatment of papulopustular rosacea.