PD0709 clinical focusacne 7/2/09 9:49 AM Page 17
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`¯ ¯ ¯ Clinical Focus: Acne
`
`By Dina Anderson, MD
`
`Finding a Place for Topical Anti-inflammatory
`Acne Therapy
`Dermatologists and patients are discovering how a novel topical therapy offers a
`different way to target acne in certain individuals.
`
`launch of topical dapsone gel 5%
`
`S everal months after the market
`
`(Aczone, Allergan), clinicians still
`seem to be trying to acquaint them-
`
`acne assessment and mean percentage
`
`demonstrated no antibacterial effects
`
`reduction in inflammatory, non-
`
`inflammatory, and total lesion counts,
`compared to controls. Statistically sig-
`
`against Streptococcuspyo£enes,
`Staghy[ococcus aureus, or Escherichia
`co[i.6 No published data report anti-
`
`selves with the agent and identify its
`ideal place in the management of ache
`patients. Patients, too, may be trying
`
`nificant improvement in lesion counts
`was evident by week four.3
`Topical application is associated
`
`bacterial effects of dapsone against P
`aches. Though, as the maxim holds,
`absence of evidence is not evidence of
`
`to familiarize themselves with this new with low systemic exposure and obvi-
`and as yet not readily identified pre-
`ates concerns about hematologic side
`effects, with studies showing that only
`
`scription product. A cursory review of
`some Internet discussion boards for
`
`ache reveal quire a bit of dialogue
`about topical dapsone but few factual
`details. The following review high-
`
`lights what we know about topical
`dapsone and its potential role in ache
`
`management,
`
`Efficacg and Safetg
`Use of dapsone for the management of
`
`acne is not entirely new. It had been
`considered a possible acute, systemic
`intervention for severe, nodulocystic,
`
`inflammatory acne, and its use for this
`indication has been advocated as
`
`absence, these facts present interesting
`questions. Publications describe topi-
`
`cal dapsone gel as an antibacterial
`agent;7 marketing materials for the
`new formulation do not mention anti-
`
`two of 50 study participants with glu-
`cose-6-phosphare dehydrogenase
`
`(G6PD) deficiency experienced a drop
`in hemoglobin levels; those fluctua-
`tions were similar to changes observed
`
`bacterial effects.
`Marketing emphasizes the anti-
`inflammatory properties demonstrated
`
`in non-G6PD deficient subjects? As
`dermatologists are aware, FDA
`
`dropped an initial requirement for
`screening for G6PD prior to topical
`dapsone therapy,
`
`A CoRtex’[
`
`by topical dapsone gel in trials.
`
`Among 486 patients who used topical
`dapsone gel twice daily for up to 12
`months, there was a 58.2 percent
`reduction in mean inflammatory
`
`lesions at the end of the study period,
`compared to a 19.5 percent reduction
`
`in mean non-inflammatory lesions?
`While data support the efficacy of topi-
`cal dapsone gel, there are no trials corn- Overall reduction in mean total lesion
`counts was 49 percent. Investigations
`paring the intervention to other avail-
`
`recently as last year.1 However, due to a
`lack of data to support the use of oral
`
`able topical therapies. Additionally,
`there may be some confusion regarding
`
`are reportedly underway to examine
`the use of topical dapsone for rosacea,
`
`dapsone for severe acne and the risk of
`adverse effects associated with the
`agent, including hematologic effects, its
`
`the agent’s method of action in acne
`vulgaris and, thus, its therapeutic role.
`Dapsone is a sulfone and has long
`
`a disease with a significant inflamma-
`tory component.7 Precisely how dap-
`
`sone confers anti-inflammatory effects
`is not fully understood.
`Given that recent recommendations
`
`use for acne has been limited.2
`been used to manage leprosy, caused
`Topical dapsone expands the poten-
`by bacteria Mycobacterium [eprae and
`from the Global Alliance to hnprove
`tial utility of the drug for acne. Several Mycobacterium [egromatosis. The drug
`publications have presented and
`has been recognized as conferring anti- Outcomes in Acne group emphasize
`reviewed the efficacy of topical dap-
`inflammatory effects beneficial in
`that ache is a chronic, inflammatory
`
`sone gel 5% in treating mild to rood-
`erately severe acne.3’4 In 12-week clini-
`
`the management of lepros~but cur-
`rent evidence questions the degree to
`
`cal trials comparing topical dapsone to which dapsone provides antimicrobial
`effects. One trial found that even at
`
`vehicle, treated patients had greater
`improvements in investigator’s global
`
`very high concentrations, dapsone
`
`disease, similar to atopic dermatitis or
`psoriasis,9 the availability of a topical
`anti-inflammatory agent may prove
`
`helpful in the clinic. Persistent con-
`cerns about developing microbial
`
`July 2009
`
`Practical Dermatology
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`17
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`PD0709 clinical focusacne 7/2/09 9:50 AM Page 18
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`¯ ¯ ¯ Clinical Focus: Acne
`
`Rosacea Flare Forecast
`
`If you notice an influx of rosacea patients during the summer months, your practice probably isn’t unique. According to a recent
`survey of rosacea patients conducted by the National Rosacea Society (NRS), about half of respondents said theirskin condition is
`worse in the summer months. Results of the survey of 1,1go rosacea patients, published in Rosacea Review, show that a majority
`(85 percent) said their rosacea is affected by changes in seasons; 46 percent said they have to make the most lifestyle adjustments
`during summer months to reduce the likelihood of a flare-up of signs and symptoms. The cold poses problems, as well. Thirty-five
`percent of all respondents and 46 percent of those who live in the northern US said their symptoms are at their worst during cold
`weather.
`
`Advising patients on preventive skincare and sun protection as well as recommending appropriate seasonal or pre-seasonal
`therapeutic modifications may help minimize exacerbations.
`
`-PD Staff
`
`resistance associated with the use of
`antibiotics also support the need for
`alternative therapeutic agents for acne
`management,
`
`Finding a Niche
`Based on the available data, topical
`dapsone seems especially well-suited
`to tile management of primarily
`inflammatory mild to moderate acne.
`Use of tile product is not associated
`with cutaneous irritation, such as
`burning or peeling common with the
`use of topical benzoyl peroxide or
`retinoids. Therefore, it is a suitable
`option for patients with sensitive skin.
`Given that tile trend in acne thera-
`py is to target as many pathogenic
`factors as possible, monotherapy is
`rarely indicated. In fact, guidelines
`suggest that most patients with mild
`to moderate acne should be managed
`or maintained with a topical retinoid,
`Topical antimicrobials, particularly
`benzoyl peroxide, are also emphasized
`in recomnlendations. Taken together,
`9
`these various considerations suggest
`that most patients prescribed topical
`
`dapsone therapy may be candidates
`for additional topical intervention(s).
`There are no published studies on
`tile use of topical dapsone in combina-
`tion with other topical acne interven-
`
`ment option for a number of patients.
`
`It offers a unique nlechanism of action
`and effectively targets inflammation
`one of the key pathogenic features of
`this ubiquitous dermatitis. ¯
`
`Dr. Anderson has served as a consultant
`to A[[ergan; She has not consulted
`regarding Aczone.
`
`1. Ochsendorf FR, Degitz K. Drug therapg of acne.
`Hautarzt. 2008 Jui;59(7):579-89.
`
`tions. The Prescribing Information
`indicates that concomitant application
`of benzoyl peroxide and dapsone gel
`produced a yellow or orange discol-
`oration of the skirl in seven of 95 sub-
`jects that lasted up to 57 days in some
`2. Wolf R, Matz H, Orion E, Tuzun B, Tuzun Y. Dapsone.
`Dermat01 Online J. 2002Jun;8(1):2.
`individuals. There is no report of the
`3. Draelos ZD, Carter E, Maloneg JM, Elewski B, P0ulin Y,
`efficacy of the combination or whether
`Lgnde C, Garrett S; United States/Canada Daps0ne Gel
`either agent inactivated tile other. Still,
`Studg Group. Two randomized studies demonstrate the
`tile risk of skirl discoloration is suffi-
`efficacg and safetg of dapsone gel, 5% for the treatment
`cient to recommend against concomi-
`of acne vulgads. J Am Acad Dermat01. 2007
`Mar;S6(3):439.el-10.
`rant application. There are no other
`4. Pickert A, Raimer S. An evaluation of daps0ne gel 5%
`reports of interactions or contraindica-
`in the treatment of acne vulgaris. Expert Opin
`dons with dapsone gel and standard
`Pharmacother. 2009Jun;lO(9):1515-21
`topical acne therapies.
`5. St0tland M, Shalita AR, Kissling RF. Daps0ne 5% gel: a
`review of its efficacg and safetg in the treatment of acne
`Dapsone gel is indicated for twice-
`vulgaris. Am J Clin Dermatol. 2009;10(4):221-7.
`daily application. However, if it is
`6. Wolf R, Orni-Wasserlauf R. A centurg of the sgnthesis
`used ill conjunction with other topi-
`of dapsone: its anti-infective capacitg now and then. Int J
`cal agents, until further evidence is
`Dermat01. 2000 0ct;39(10):779-83.
`available, it may be wise to reduce
`7. Scheinfeld N. Acz0ne, a topical gel formulation of the
`antibacterial, anti-inflammatorg dapsone for the treat-
`application of dapsone to once daily
`ment of acne. Curr Opin Investig Drugs. 2009
`and substitute a retinoid or antimicro- Mag;lO(5):474-81.
`bial, such as benzoyl peroxide, at the
`8. l,uckg AW, Mal0neg JM, R0bertsJ, Tagl0r S, Jones T,
`other application time.
`l,Ung M, Gamett S; Daps0ne Gel 1,0ng-Term Safetg Studg
`Group. Dapsone gel 5% for the treatment of acne vul-
`Although topical dapsone gel may
`gads: safetg and efficacg of long-term (1 gear) treat-
`not become a flrst-line treatment
`ment. J Drugs Dermat01. 2007 0ct;6(10):981-7.
`option for a majority of people with
`9. Thib0ut0t D, G011nick H, Bett0D V, Dr4n0 B, Kang S,
`l.egden JJ, Shalita AR, 1.0zada VP, Bers0n D, Finlag A, G0h
`acne, it may be an important treat-
`CL, Herane MI, Kaminskg A, Kubba R, l,agton A, Migachi Y,
`Perez M, Martin JP, Ramos-E-Silva M, See JA, Shear N,
`W01f J Jr; Global Alliance to Improve Outcomes in Acne.
`New insights into the management of acne: an update
`from the Global Alliance to Improve Outcomes in Acne
`group. J Am Acad Dermatol. 2009 Mag;60(5 Suppl):S1-
`50.
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`Practical Dermatology
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`July 2009
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`2 of 2
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