[CASE SERIES]
`
`The Use of Sodium Sulfacetamide 10%-
`Sulfur 5% Emollient Foam
`in the Treatment of Acne Vulgaris
`
`JAMES Q. DEL ROSSO, DO, FAOCD
`Valley Hospital Medical Center, Las Vegas, Nevada
`
`ABSTRACT
`Acne vulgaris is the most common disorder encountered in mnbulatmT clinical practice comprish~g 11.3 percent of
`office visits to demlatologists in 2005.1 By comparison, eczematous demlatoses, psoriasis, and sku~ cancer accounted
`for 6.2, 3.5, and 10 percent of office visits, respectively.1 A variety of topical therapeutic options are available for
`treatment of acne vulgaris, u~cludu~g benzoyl peroxide, antibiotics, retumids, azelaic acid, and sodium sut[acetamide-
`sulfur)’3 Sodium sulfacetamide 10%-sulfur 5% has been used for the topical treatment of seborrheic demmtitis, acne
`vulgaris, and rosacea su~ce the mid-1950s and is available u~ a variety of fmTaulations, u~cludu~g lotions, creams,
`cleansers, and emollient foams.4 Recently, an emollient foam sodium sulfacetamide 10%-sulfur 5% fommlation indicated
`for topical therapy of acne vulgaris, rosacea, and seborrheic demmtitis has become available.~ This article provides an
`ove~wiew of the sodium sulfacetamide 10%-sulfur 5% emollient foam and reports the results of a case report series of
`patients with acne vulgaris treated with sodium sulfacetamide 10%-sulfur 5% emollient foam as monotherapy or u~
`combumtion with other topical acne products. (J Ctir~ Aestt~etic Derrr~atot. 2009;2 (8):26 29.)
`
`o o
`
`foam was used as a leave-on fommlation according to
`rT~he sodium sulfacetamide 10~-sulfur 5~ (SSS)
`| emollient foam is fommlated as an alcohol-fi’ee and directions outlhmd in the product prescribing hffommtion.
`..L fi-agrm~ce-fi-ee topical aerosol foam that has been The fi’equency of application and use of any concomitant
`shown to exhibit moisturization propertiesP’~ An
`therapies were detemlhmd by the author who evaluated
`evaluation of the rate of release of the active ingredients
`and treated all patients included in the case series.
`fi’om the SSS emollient foam fmTaulation demonstrated
`active release characteristics conducive to both wash-off CASE {
`and leave-on treatment regimens in clinical practice/ In
`A 35-year-oM Asian woman presented with facial acne
`addition, SSS emollient foam has been shown to markedly vulgaris "on and off’ for a duration of several years. She
`reduce colony counts of Propior~ibacteri~zrr~ aeries ir~
`reported that her acne had not responded to treatment
`vitro.8 Lastly, SSS emollient foam has been shovm to with benzoyl peroxide (BPO) 5.5% cream over the past
`exhibit reduced sulfur odor intensity as compared to other
`few months. On examination, she exhibited 15
`conventional SSS fommlations,9 without the use of hfflammatm7 papules and 26 closed comedones. She was
`potentially sensitizing, odor-maskh~g additives, such as prescribed SSS emollient foam in the morning and
`fragrance,
`trethmh~ microsphere gel 0.04% at bedtime.
`At the follow-up visit four weeks later, the number of
`CASE SERIES
`facial papules and comedones decreased to seven and 15,
`respectively. She reported mild pruritus of the temple
`The following case series discusses the use of SSS
`regions over the first few days of medication use, which
`emollient foam in the treatment of mild-to-moderate acne
`resolved without discontinuation of therapy. There was no
`vulgaris either as monotherapy or in combination with
`other topical acne medications. In all cases, SSS emollient visible evidence of cutmmous side effects on examination.
`
`DISCLOSURE: Dr. Del Rosso is a consultant, speaker, and/or researcher for Allergan, Coria, Galderma, Graceway, Intendis, Medicis, Onset
`Therapeutics, Obagi Medical Products, Ortho Dermatology, PharmaDerm, Quinnova, Ranbaxy, SkinMedica, Stiefel, Triax, Unilever, and Warner-Chilcott.
`ADDRESS CORRESPONDENCE TO: James Q. Del Rosso, DO, FAOCD; E-mail: jqdelrosso@yahoo.com
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`At the eight-week follow-up visit, the number of facial papules and 30 noniifflammatmT lesions (predominantly
`papules and comedones decreased to three and three,
`closed comedones) were noted, involving the forehead,
`respectively. Intemfittent mild d~7/ness of the temple
`temple, cheeks, and chin. Mild postinflammatmT
`hype~oigmentation was also noted. The patient was
`regions, which was not evident on clinical examination,
`was reproved by the patient; however, this subjective prescribed SSS emollient foam to be applied twice daily.
`finding did not result in discontinuation of treatment.
`At her four-week follow-up visit, seven iifflammatmT
`With regard to use of the SSS emollient foam, the patient papules and 27 noninflammatory lesions were noted. She
`stated it was very easy to apply and that she was satisfied
`reported mild facial d~7/ness, which was ameliorated by
`use of a facial moisturizer cream without interruption of
`with the results of her treatment program,
`therapy. Examination at eight weeks revealed six
`iifflammatmT~ papules and 19 comedonal lesions. No
`adverse reactions were reported or observed. The patient
`reported that SSS emollient foam was easy to apply, and
`satisfaction with response to treatment was high. The
`current regimen was continued.
`
`CASE 2
`A 29-year-oM Asian woman presented with a 10-year
`histmT/ of intemfittent facial acne vulgaris involving
`predominantly the forehead region and occasionally the
`cheeks. She describes her acne as mild, but frustrating,
`stating, "there are always a few, especially on the
`forehead." She has separately used tretinoin cream CASE 5
`0.025% daily and BPO cream 3.5% with modest success.
`A 14-year-old Caucasian girl presented with t~cu~cal
`On examination, 12 iifflammatmy papules and 10 closed
`acne vulgaris involving the back over the past few years.
`comedones were noted. The patient was prescribed SSS Despite the use of BPO creamy wash 8% daily there was
`emollient foam once daily,
`some persistence of acne lesions that was bothersome to
`At follow up six weeks later, the number of
`the patient. On examination, 17 iifflammatmy papules and
`inflammatory lesions decreased to three and no
`40 closed comedones were noted on the back. BPO
`creamy wash 8% once daily was continued and SSS
`comedones were observed. Two weeks later (Week 8), no
`emollient foam twice daily was added to the regimen.
`iifflammatmT/ lesions were noted and only one closed
`After four weeks of treatment, the patient reported
`comedone was observed. No adverse reactions were
`reported or observed. With regard to use of SSS emollient marked improvement. On examination, six iifflaimnatmy
`foam, the patient reported that it was ve~7/ easy to use and papules and 12 closed comedones were observed.
`aesthetically pleasing. She was ve~7/ satisfied with the
`Improvement progressed through Week 8 with one
`results of treatment, and the current regimen was
`inl]aimnato~3z papule and three closed comedones noted.
`No adverse reactions were repm%ed or observed at either
`continued.
`visit. The patient and her mother stated they were very
`CASE 3
`satisfied with the treatment results and reproved that SSS
`A 13-year-old Asian boy presented with a one-year
`emoUient foam was ve~7/easy to apply and was aesthetically
`histmT/ of facial acne vulgaris that was only modestly pleasing to use. The current treatment regimen was
`responsive to previous treatment with BPO 5%-
`continued.
`clindamycin 1% gel. Clinical examination demonstrated
`23 iifflammatm~ lesions (predominantly papules with no CASE 6
`A 19-year-oM Caucasian woman presented with facial
`nodules) and 31 noniifflammatmT/lesions (predominantly
`acne vulgaris present for several months. Previous
`open comedones) (Figure 1). The predominant areas of
`involvement were the forehead and cheeks. The patient
`treatment had included a BPO-containing skin care
`was prescribed SSS emollient foam in the morning and
`system, topical adapalene, and oral minocycline. The
`tretinoin microsphere gel 0.04% in the evening,
`patient has been off of all treatment for several months
`Follow up at eight weeks revealed 16 inflammatmT/
`and admits to inconsistent compliance with previous
`lesions and five closed comedones (Figure 2). No adverse
`therapies. On examination, 22 inflammatory lesions
`reactions were reported or observed. The patient stated
`(predominantly papules with no nodules) and 36
`that SSS emollient foam was easy to apply, and he was noninflammatmT/ lesions (predominantly closed
`satisfied with the results of therapy. The cmTent regimen
`was continued,
`
`comedones) were observed on the forehead, cheeks, and
`chin. The patient was instructed to apply SSS emollient
`foam in the morning and tazarotene cream 0.1% in the
`evening. Additionally, the patient was administered a
`ceramide-based moistm%er cream to be applied in the
`evening prior to application of topical tazarotene.
`At the four-week follow-up visit, 27 iifflammatmT/
`
`CASE 4
`A 30-year-oM Asian woman presented with a 15-year
`
`histmT/ of facial acne vulgaris treated previously with
`multiple medications including topical tretinoin,
`clindamycin, and adapalene for durations of
`lesions and 24 noniifflammatmT/lesions were noted. The
`approximately three months. The patient had patient reported mild facial redness occurring after
`discontinued therapy with topical adapalene two weeks
`application of topical tazarotene; however, this dissipated
`prior to her visit. On examination, eight iifflammatmT/ by the following morning and did not interfere with
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`FIGURE 1. Multiple inflammatory and comedonal ache lesions
`noted on the forehead at baseline,
`
`FIGURE 2. Marked reduction in inflammatory and comedonal
`ache lesions on the forehead observed after eight weeks of
`treatment. Note significant improvement with only residual
`post-inflammatory erythema and hyperpigmentation.
`
`continuation of treatment. By Week 8, the numbers of
`
`foam twice daily was prescribed.
`At the four-week follow-up visit, iifflammato<~ and
`inflammato<~ and noniifflammato<~ lesions were 12 and
`noniifflmmnato<~ lesions decreased to eight an(] seven,
`26, respectively. Regarding the use of SSS emollient foam,
`respectively. Follow up at Week 8 demonstrated seven
`the patient reported it was easy to use and exhibited good
`ii~anmlato~# papules and seven closed comedones. Facial
`aesthetic qualities. Additionally, she was satisfied with the
`results of the treatment regimen, which was continued dryness was reproved by the patient, but did not interfere
`with the addition of oral doxycycline,
`with treatment. No other adverse reactions were reported or
`observed. The patient stated that SSS emoUient foam was
`easy to apply an(] aesthetically pleasing. She was moderately
`satisfied with the results of treatment, but requested a
`switch in her therapy to an alternative approach that wouM
`lead to further clearance of acne lesions.
`
`CASE 7
`A 32~ear-old Caucasian man presented with facial
`acne vulgaris present for several months involving the
`forehead and cheeks. He had previously utilized BPO 5%-
`clindamycin 1% gel with modest success, with cutaneous
`d~37ness leading to inconsistent use. Clinical evaluation DISCUSSION
`revealed 19 inflammato<~ lesions (predominantly papules)
`The above cases demonstrate the use of SSS emollient
`and 14 noniifflammato<~ lesions (predominantly closed
`foam in the treatment of mild-to-moderate acne vulgaris
`comedones). The patient was instructed to use SSS
`as either monotherapy or in combination with a topical
`emollient foam in the morning and tretinoin 0.05%
`retinoid. Use of a topical retinoid is a nminstay of both
`initial and maintenance treatment of acne vulgaris.2
`aqueous gel in the evening,
`After four weeks, the inflammato<~ and Application of a topical retinoid often causes some degree
`noniifflammato<~ lesion counts decreased to five and nine,
`of cutaneous irritation ("retinoid demmtitis") within the
`respectively. At Week 6, eight iifflammato<v papules and
`first few weeks of use. Therefore, the availability of other
`one closed comedone were observed. No adverse
`topical agents that are iifl~erently not irritating and that do
`reactions were reported or observed over the course of not compound the potential for or the intensity of
`"retinoid demmtitis" is an importm~t factor when selecting
`treatment. With regard to SSS emollient foam, the patient
`stated it was ve<~ easy to apply with very good aesthetic
`topical agents for use in combination to treat acne
`characteristics. He was satisfied with the response to
`vulgaris. In the cases where SSS emollient foam was used
`in combination with a topical retinoid, the cutaneous
`treatment,
`tolerability was favorable and all patients continued
`treatment without interruption. This may relate at least
`CASE 8
`A 23-year-old Caucasian woman presented with a partially to the moisturization properties of the SSS
`recent flare of facial acne vulgaris involving prinmrily the
`emollient foam vehicle.6
`forehead and cheeks over the past two months. She was
`Recognized advantages of a foam vehicle include rapid
`previously treated with oral minocycline for only a short penetration into the skin without a messy residue,
`cosmetic acceptability, and ease of use, especially for
`duration. A total of 18 iifflammato<~ papules and 19 closed
`comedones were noted on examination. SSS emollient widespread application.1° The case involving t~cmcal acne
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`on the back was effectively treated with SSS emollient
`foam and a BPO cleanser.
`In summa~% SSS emollient foam is indicated for the
`treatment of acne vulgaris, as well as seborrheic demlatitis
`and rosacea. SSS emollient foam appears to be a welcome
`addition to the therapeutic amlamentarium based on
`formulation characteristics, active ingredient release
`properties, moisturization capacity, and clinical use.
`
`2.
`
`RI:FI:RI:N~F~
`1.
`Centers for Disease Control and Prevention, National Center
`for Health Statistics, 2005 National Ambulatory Medical Care
`Survey, March 2005.
`Golh~ick H, Cmfliffe W, Berson D, et al. Management of acne:
`a report from a global aUiance to improve outcomes in acne. d
`ArnAc~tdDerrr~tto[. 2003;49 (Suppl):S1~S37.
`Gupta AK, Nicol K. The use of sulfur in dem~atology, dDr~gs
`Derrr~tto[. 2004;3:42~431.
`Del Rosso JQ. Evaluating the role of topical therapies in the
`management of rosacea: focus on combination sodium
`sulfacetamide and sulfur fom~ulations. C’~t’ts. 2004;73 (Suppl
`
`3.
`
`4.
`
`1):29~3.
`Clm’ifoam-EF Emollient Foam [package insert]. Cm~berlm~d,
`
`5.
`
`6.
`
`7.
`
`RI: Onset Therapeutics; 2008.
`Trtm~bore M. The moisturization ability of a sodium
`sulfacetamide (10%)/sulfur (5%)emo~entfoam. YAmAc~d
`De//¢r~tol. 2007;56:AB21 (Abstract P134).
`%’m~bore MW, Macey JM, Schillil~ W. The rate of release of
`active ingredients from a novel wash-off and leave-on sodium
`sulfacetamide 10%/sulfur 5% emollient foam. Poster
`presented at: 66th Annual Meeting of the American Academy
`of DelTnatology; Febmaly 1 5, 2008; San Antonio, TX.
`Trm~bore MW. The development of an i~r~-~oitro assay for
`detemfil~ the m~timicrobial efficacy of leave-on and wash-
`off topical acne medications. Poster presented at: American
`Academy of DelTnatology Suromer Academy Meeting; August
`1 5, 2007; New York, N~
`Gm’ge R, Trm~bore MW, Varanasi R. The evaluation of a novel
`pham~aceutical foam vehicle teclmology optimized to
`improve patient compliance. Poster presented at: American
`Academy of Dem~atology Summer Academy Meeting; duly
`30 August 3, 2008; Chicago, IL.
`10. Housman TS, Mellen BG, Rapp SR, et al. Patients with
`psoriasis prefer solution and foam vehicles: a quant-
`itative assessment of vehicle preference. C’~tis. 2002;70:
`327 332. ¯
`
`8.
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`9.
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