Use of Dapsone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Dapsone 5% Gel Combination Treatment
February 2016 | Volume 15 | Issue 2 | Original Article | 191 | Copyright © 2016
Leon H. Kircik MD
Icahn School of Medicine at Mount Sinai, New York, NY; Indiana University School of Medicine, Indianapolis, IN;
Physicians Skin Care, PLLC, Louisville, KY
BACKGROUND: Acne vulgaris is a common, chronic skin disease that requires long-term therapy. Oral antibiotics are a mainstay of treatment, but extended use is associated with the development of bacterial resistance. Topical therapies are often combined with oral antibiotics to achieve an initial improvement, after which the oral agents may be discontinued and the topical therapy used as maintenance.
OBJECTIVE: To assess the safety and efficacy of combination therapy with dapsone 5% gel with oral doxycycline hyclate 100mg, followed by monotherapy with dapsone 5% gel in improving and maintaining response in patients with moderate to severe acne.
METHODS: In this open-label study, all patients applied dapsone 5% gel twice daily along with doxycycline hyclate 100mg once daily for 12 weeks. Subjects who achieved a qualifying improvement at week 12 continued to the second phase of the study in which they applied only dapsone 5% gel twice daily for maintenance therapy of 12 more weeks. Subjects were evaluated for safety and efficacy at weeks 4, 8, 12, 16, 20, and 24.
RESULTS: All subjects (n=30) in the initial phase qualified to enter the maintenance phase. 82% of participants maintained their treatment response (Investigator’s Global Assessment score) at week 24. The regimen was safe and well tolerated.
CONCLUSIONS: The combination oral doxycycline hyclate 100 mg with topical dapsone 5% gel twice daily is an effective and well-tolerated regimen to treat moderate to severe acne vulgaris. After discontinuation of doxycycline, topical dapsone 5% gel is effective at maintaining a therapeutic response. These data suggest that topical dapsone 5% gel can be used effectively for long-term acne maintenance treatment without the risk of developing antibiotic resistance.
J Drugs Dermatol. 2016;15(2):191-195.
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In the real world, acne is a chronic disease that requires maintenance treatment beyond the 12-week evaluation period used in most clinical trials. Combination therapy, using different drugs with complimentary mechanisms of action is considered standard of care in treating acne. While oral antibiotics are commonly used initially to control moderate to severe acne, they should not be used as long-term maintenance because of the risk of promoting bacterial resistance. Topical retinoids have traditionally been the preferred option for maintenance therapy.1,2 Topical dapsone 5% gel has been approved for treatment of acne vulgaris since 2005. It has been used for acne vulgaris with proven efficacy and safety during post marketing in addition to a long-term safety study.3 However, there is a paucity of data evaluating topical dapsone 5% gel as maintenance following a successful course of antibiotics.
The current study investigated whether dapsone 5% gel could be used to maintain a therapeutic response in moderate to severe acne patients who were assessed to be responsive to initial combination treatment with oral doxycycline hyclate 100 mg once a day and dapsone 5% gel twice a day for 12 weeks.
Thirty two subjects with moderate to severe facial acne vulgaris were enrolled into this two-site, open-label, pilot study. Subjects entered into a 12-week initial treatment phase followed by a 12-week maintenance phase for qualifying patient. In the initial treatment phase, patients received doxycycline hyclate 100 mg once daily in combination with dapsone 5% gel twice daily. In the maintenance phase, the oral antibiotic was discontinued and patients applied dapsone 5% gel twice daily as monotherapy. Participants had 7 study visits; baseline and weeks 4, 8, 12, 16, 20, and 24. At the week 12 visit, subjects who achieved a qualifying treatment response, moved on to the maintenance phase. Subjects who did not achieve a qualifying treatment response at week 12 were discontinued from the study.
The sample size of 32 subjects was chosen based on the assumption that 66% of subjects (approximately 20 subjects) enrolled would achieve treatment response and crossover into the second phase of the study. Data from the study will highlight any trends regarding the safety and efficacy of the study medication.