Sulfur/Sodium Sulfacetamide Preparations

95March • April 2004

C l i n i c i a n ’ s Q u i c k R e f e r e n c e

In recent months, a slew of preparations containing sulfur, sodium sulfacetamide, or combinations of these two have made

their way into the dermatologic therapeutic armamentarium. The sheer number of new com-pounds and their many similarities necessitates a brief overview focusing on distinctive properties and the advantages of each.

A brief introduction and a review of general mechanisms of action and indications follow. On the basis of advertisement through promo-tional material and contacts with marketing personnel, we have summarized the advan-tages of each product, and the Table graphically illustrates their differences and facilitates the critical analysis of their purported virtues.

Hippocrates used sulfur in the treatment of plague, and it has been used for medicinal purposes ever since.1 Sulfur preparations are produced in the following forms:

• Sublimed sulfur, a fine, yellow, crystal-line, water-insoluble powder

• Precipitated sulfur, a much finer powder with a greater reactive surface than sublimed sulfur and the most common form of sulfur used in dermatology, available in bar soaps, shampoos, gels, lotions, and creams

• Colloidal sulfur, the most active form of sulfur in products for acne and seborrhea with added antibacterial activity,2,3 which has the smallest particle size compared with the previous two forms listed, and therefore, because the therapeutic effect of sulfur is dependent on its particle size, colloidal sulfur provides a greater relative clinical efficacy than either sublimed sul-fur or precipitated sulfur3,4

• Sulfurated potash• Sulfurated lime• Washed sulfur.4

Particle size and water and alcohol solubility determine which vehicle of delivery is pre-ferred for the various sulfur preparations.

Clinical PharmacologySulfur has keratoplastic effects at low con-centrations and keratolytic effects at higher concentrations.5 It is believed to react with cys-teine inside keratinocytes, forming cystine and releasing hydrogen sulfide2; higher concentra-tions of sulfur therefore lead to higher amounts of hydrogen sulfide in the cells.6 Although an initial hyperkeratosis occurs at the treated site owing to a slowing of the desquamation of keratin (keratoplastic effect), this keratin is broken down by hydrogen sulfide. Sulfur exerts antifungal activity through formation of pen-tathionic acid by cutaneous bacteria and kera-tinocytes as well as via its keratolytic action.2 There is some controversy over whether sulfur is comedolytic or comedogenic7–9; however, the irritant effect of sulfur, leading to peeling, appears to be of benefit to patients with acne.2 It has been reported that sulfur inhibits the growth of Propionibacterium acnes and the for-mation of free fatty acids.3

Sodium sulfacetamide is a sulfonamide with antibacterial activity. It is believed to block bacterial growth by acting as a competitive antagonist of para-aminobenzoic acid.10 Thus, the sulfonamides are bacteriostatic rather than bactericidal; they starve the bacteria rather than killing them directly, decreasing concern regard-ing development of drug resistance. The cur-rently available products discussed here contain either a combination of sulfur and sodium sulfa-cetamide or sodium sulfacetamide alone.

Indications and UsageSulfur and sodium sulfacetamide products are used in dermatology to treat acne vulgaris, rosacea, perioral dermatitis, and seborrheic

From the Departments of Dermatology and Medicine, Baylor University Medical Center, Dallas, TX; and the Department of Dermatology, University of Texas Southwestern Medical Center at Dallas, Dallas, TX;1 University of North Texas Health Sciences Center, Texas College of Osteopathic Medicine, Fort Worth, TX2

Address for correspondence: William Abramovits, MD, Texas Dermatology Associates, PA,5310 Harvest Hill Rd, Suite 260,Dallas, TX 75230 E-mail: [email protected]

Sulfur/Sodium Sulfacetamide PreparationsWilliam Abramovits, MD;1 Angela J. Kennedy, BS2


www.lejacq.com ID: 3413

SKINmed: Dermatology for the Clinician (ISSN 1540-9740) is published bimonthly (Jan., March, May, July, Sept., Nov.) by Le Jacq Communications, Inc., Three Parklands Drive, Darien, CT 06820-3652. Copyright ©2004 by Le Jacq Communications, Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing from the publishers. The opinions and ideas expressed in this publication are those of the authors and do not necessarily reflect those of the Editors or Publisher. For copies in excess of 25 or for commercial purposes, please contact Sarah Howell at [email protected] or 203.656.1711 x106.

96 March • April 2004

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dermatitis, dermatitis sicca, and cutaneous infections such as scabies, tinea versicolor, and dermatophyte infections.

Warnings and ContraindicationsThese products are contraindicated for use in patients with known hypersensitivity to sulfon-amides, sulfur, or any other component of these preparations. Sensitivity to sodium sulfaceta-mide may occur, so caution and careful supervi-sion should be observed when prescribing this drug for patients who may be prone to hyper-sensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, hemorrhagic purpura, drug fever, jaundice, and contact dermatitis are fea-tures of hypersensitivity to sulfonamides.10

Products should remain tightly closed, away from eyes, and out of reach of children. They are not to be used in patients with kidney dis-ease. They may cause reddening and scaling of the epidermis, side effects not unusual in the treatment of acne; local irritation is a rare adverse reaction. Particular caution should be employed if areas of denuded or abraded skin are involved. If irritation develops, use of the product should be discontinued and appropriate therapy instituted.10

These products are generally category C and should be given to a pregnant woman only if clearly needed. It is not known whether sodium sulfacetamide is excreted in human milk following use of many of these topical products, but small amounts of orally admin-istered sulfonamides have been reported to be eliminated in human milk. Therefore, cau-tion should be exercised when these medica-tions are administered to nursing women.10

Relevant Selling Points and Purported AdvantagesWe compiled information gathered from advertising materials, Web sites, and data provided by the pharmaceutical companies marketing each product to present the advan-tages to be perceived by using these products. As a group, it is claimed that these products:

• Will not bleach clothing (in contradistinction to benzoyl peroxide-containing products)

• Provide a broad spectrum of antimicro-bial activity against both gram-positive and gram-negative bacteria including P.

acnes as well as the yeast P. ovale and some dermatophytes11

• Are comedolytic and keratolytic.

It is worth noting that many promotions emphasize what in reality is inherent to any and all sulfur/sodium sulfacetamide formula-tions as particularly relevant to their product.

We exercised utmost discretion in qualifying as fairly as possible those claims that seem unique to a given formulation. Brands are alphabeti-cally arranged, and supporting data for claims of superiority are provided when available.

Avar Cleanser, Gel, and Green Color Corrective Gel. Avar (Sirius Laboratories, Vernon Hills, IL) combines the mechanisms of colloidal sulfur, sodium sulfacetamide, nicotin-amide, and zinc.• Contains added emollients• Demonstrated as effective in vitro against

P. acnes as 10% benzoyl peroxide gel2

• Cleanser is 20%–25% less expensive per gram vs. other sulfacetamide-based cleansers2

• Cleansing base is more similar to Cetaphil (Galderma, Ft. Worth, TX) cleanser than either Rosanil (Galderma, Ft. Worth, TX) or Plexion (Medicis, Scottsdale, AZ) cleansing bases2

• The first and only line of emollient gel formulations of sulfacetamide and col-loidal sulfur2

• Gel is light, nongreasy, water-based, and alcohol-free

• Green Color Corrective Gel is sheer, trans-lucent, contains inert green pigment to help neutralize the appearance of erythe-ma, and is not a heavy mask or cover-up. When white light is filtered through Avar Green, the combination of red (erythema-tous skin) and green light is perceived as a more neutral yellow flesh tone.2

Carmol Scalp Treatment Lotion and Kit. Carmol (Doak Dermatologics, Fairfield, NJ) is a nonsteroid therapeutic option for patients suffering from seborrheic dermatitis, scaling dermatoses, and seborrhea sicca.• Carmol Scalp Treatment Kit includes

Carmol Deep Cleansing Antibacterial Shampoo, Carmol Scalp Treatent Lotion with applicator, and the Carmol Scalp Treatment Brush, all preassembled for convenience.12




Clenia Foaming Wash and Emollient Cream. Clenia (Upsher-Smith Laboratories, Inc., Maple Grove, MN) is a unique two-in-one system consisting of both a foaming wash and emollient cream.• Innovative wash packaging and conve-

nient pump delivery13

• Scent may improve compliance over other sulfur products

• Cosmetically elegant• Alcohol-free complementary system.14

Klaron Lotion. Klaron (Dermik Laboratories, Berwyn, PA) is an alcohol-free, aqueous-based formulation developed for sensitive skin.• Clear, silky smooth lotion for easy application• No generic formulation is available• In a double-blind, parallel comparison study

with a total of 54 patients randomized to either Klaron or vehicle, the mean percent reduction in inflammatory lesions was sig-nificantly (p=0.001) greater for the Klaron group vs. the vehicle group (personal com-munication, Dermik Laboratories, 2003)

• In a vehicle-controlled study conducted at two centers and with 140 patients entered and 121 completing the study, the phy-sicians’ global assessment significantly (p<0.05) favored Klaron compared with vehicle at weeks 4, 8, and 10 (personal com-munication, Dermik Laboratories, 2003)

• A study involving 27 patients concluded that Klaron possessed a low or minimal potential for irritation and did not cause delayed con-tact hypersensitivity (personal communica-tion, Dermik Laboratories, 2003)

• A study involving 27 volunteers showed no photosensitizing potential in humans with Klaron use (personal communica-tion, Dermik Laboratories, 2003)

• In a study comparing Klaron to Cleocin T (clindamycin phosphate, Pharmacia & Upjohn Company, Kalamazoo, MI) lotion in the treatment of acne vulgaris, the Klaron treatment group showed signif-icantly greater efficacy compared with clindamycin phosphate. Patient global evaluations of the intent-to-treat end point and comedone reductions of the evaluable end point significantly favored Klaron over clindamycin phosphate (personal commu-nication, Dermik Laboratories, 2003)

• Overall cosmetic acceptability significantly preferred by physicians over Cleocin T lotion 1%15

• Sixty percent of physicians surveyed indicated they would prescribe Klaron over Cleocin T lotion 1% when asked to choose between the two (personal com-munication, Dermik Laboratories, 2003).

Nicosyn Collodial Suspension. Nicosyn (Sirius Laboratories, Vernon Hills, IL) uses colloidal sulfur.• The formula addresses the problems of

inflammatory reaction, follicular obstruc-tion, and bacterial proliferation in the pathogenesis of acne

• Contains nicotinamide and zinc, which inhibit leukocytic chemotaxis, leukocytic release of lysosomal enzymes, lympho-cytic transformation, release of vasoactive amines, and activity of P. acnes lipase2

• Topical nicotinamide alone has demon-strated efficacy in patients with inflamma-tory acne in three multicenter, randomized clinical trials with 1045 patients. Acne severity rating, acne lesion count, and physician’s global evaluation were assessed, and topical nicotinamide alone was found to offer significant improvement in acne.16

Ovace Wash and Foam. Ovace (Healthpoint Dermatology, Ft. Worth, TX) provides conve-nient, gentle, odor-free therapy.• Safe, nonirritating formula• Does not contain sulfur, which tends to

cake and leave an unpleasant odor.

Plexion Cleanser, Lotion, and Short Contact Therapy (SCT). Plexion cleanser helps con-trol redness and irritation.• Smooth texture is cosmetically elegant• Gentle formulation will not irritate

inflamed skin17

• Plexion SCT is a unique formulation incor-porating hydrophilic and lipophilic absor-bents, along with sulfur and sodium sulfa-cetamide, that simultaneously adsorbs and removes irritating and inflammatory debris from the skin and helps to uncover added cutaneous absorption sites for sulfur, sodium sulfacetamide, and possibly other topical therapies (personal communication, Medicis Pharmaceutical Corp., 2003)

• Plexion SCT promotes patient compli-ance; users report that their skin is less oily, smoother, and softer, and that skin and pores look and feel cleaner

• Plexion SCT has a substantial patent




pending, and there is no generic com-petition (personal communication, Medicis Pharmaceutical Corp., 2003)

• Scientific data supporting Plexion SCT include absorption of active sulfur from SCT into both the epidermis and dermis, reduction in inflammatory mites in the skin of rosacea subjects, and bactericidal activity against P. acnes (personal communication, Medicis Pharmaceutical Corp., 2003)

• A 4-week, five-center, randomized and investigator-blinded clinical study showed that Plexion SCT was able to significantly enhance the efficacy of a topical retinoid such as Differin (adapalene gel; Galderma, Ft. Worth, TX) (personal communication, Medicis Pharmaceutical Corp., 2003).

Rosac Cream. Rosac (Stiefel Laboratories, Coral Gables, FL) is formulated with a sun-screen for added protection.• Contains octinoxate (UVB protection)

and avobenzone (UVA protection), with a total sun protection factor of 18

• Contains seven different emollients, includ-ing dimethicone, which helps to reduce irritation (personal communication, Stiefel Laboratories, Coral Gables, FL)

• A study involving 50 subjects comparing Rosac to Metrocream (Galderma, Ft. Worth, TX) found that after 12 weeks, there was a global investigator reported improvement in mean inflammatory lesion count of 82% in the Rosac treatment group, compared with 68% in the Metrocream group

• Sixty-three percent of subjects had a statistical-ly significant improvement in erythema with Rosac, as opposed to a 42% with Metrocream

• After 12 weeks a significantly greater pro-portion of subjects using Rosac (83%) had improvement in investigator global severity assesment vs. Metrocream patients (58%)

• Subject tolerance of Rosac was rated as “excellent” in 91% of subjects and “good” in 9% (personal communication, Stiefel Laboratories, Coral Gables, FL).

Rosanil Cleanser. Rosanil (Galderma, Ft. Worth, TX) provides a fragrance-free formula• Neutral pH (6.8)• Smooth, elegant texture.18

Rosula Aqueous Gel. Rosula (Doak Dermatologics, Fairfield, NJ) has effective, multiple therapeutic actions.

• The formulation’s vehicle includes 10% urea, a highly successful humectant that promotes moisture retention and dis-solves rough, dry, flaky skin

• Urea helps soften skin and offset potential drying; relieves dryness, redness, and associ-ated itching; and protects sensitive skin19

• A recent study examining facial tolerability in rosacea or acne patients with sensitive skin demonstrated that the majority of highly sensitive individuals in the study were able to tolerate daily or twice-a-day use of Rosula aqueous gel without irritation12

• In a June 2003 study, Rosula showed statistically significant improvement in dryness and erythema vs. Plexion.

Sulfacet-R (Dermik Laboratories, Berwyn, PA) Lotion and Tint-Free Lotion. Sulfacet-R’s tinted formula is usable as foundation makeup.

Sulfoxyl Lotion Regular and Sulfoxyl Lotion Strong. Sulfoxyl (Stiefel Laboratories, Coral Gables, FL) brand offers topical acne therapy available in two strengths.• Ideal for recalcitrant acne and acne of the

chest and back.20

Zetacet Lotion and Topical Suspension. Zetacet (Stiefel Laboratories, Coral Gables, FL) products dry clear and are• Fragrance free• Easy to apply21

• The lotion is alcohol free.

CommentaryIn the final analysis, the choice of one product over another will be dictated by the dermatologist’s judgment on which vehicle is most appropriate for the diagnosis and area affected (e.g., for sebor-rheic dermatitis of the scalp a shampoo or a foam may be preferred, whereas for rosacea a lotion or cream may be the better choice). Further, the addi-tion of sunscreen may add convenience for the daytime, and a preparation with a moisturizing feel may appeal to a patient with dry skin while a cleanser or gel may be best for those perceived to have an oily complexion. A green tint or a founda-tion-like product may appeal to a very red-faced individual. Within a given indication, if one prod-uct has shown a better effectiveness/safety profile it should be chosen over the others, provided that compliance issues do not prevail. Cost may be rel-evant to some. Without doubt, in this instance the art challenges the science of dermatology.




1 Harvey SC. Antiseptics and disinfectants; fungi-cides; ectoparasiticides. In: Gilman AG, Goodman LS, Rall TW, et al., eds. The Pharmacological Basis of Therapeutics. 7th ed. New York, NY: MacMillan; 1985;959–979. Cited by: Hessel AB, Cruz-Ramon J, Lin A. Agents used for treatment of hyper-keratosis. In: Wolverton SE. Comprehensive Dermatologic Drug Therapy. Philadelphia, PA: WB Saunders Co; 2001:671–684.

2 Avar promotional materials provided by Sirius Laboratories, Northlake, IL, 2003.

3 Avar [package insert]. Vernon Hills, IL: Sirius Laboratories, Inc; 2003.

4 Hessel AB, Cruz-Ramon J, Lin A. Agents used for treatment of hyperkeratosis. In: Wolverton SE. Comprehensive Dermatologic Drug Therapy. Philadelphia PA: WB Saunders Co; 2001:671–684.

5 Strakosch EA. Studies on ointments. Arch Dermatol Syphilol. 1943;47:216–225. Cited by: Hessel AB, Cruz-Ramon J, Lin A. Agents used for treatment of hyperkeratosis. In: Wolverton SE. Comprehensive Dermatologic Drug Therapy. Philadelphia, PA: WB Saunders Co; 2001:671–684.

6 McMurtry CW. Dermatologic therapeutics: sul-fur. J Cutan Dis. 1913;31:322–328, 399–408. Cited by: Hessel AB, Cruz-Ramon J, Lin A. Agents used for treatment of hyperkeratosis. In: Wolverton SE. Comprehensive Dermatologic Drug Therapy. Philadelphia, PA: WB Saunders Co; 2001:671–684.

7 Hjorth N. Traditional topical treatment of acne. Acta Derm Venereol (Stockh). 1980;89:53–55. Cited by: Hessel AB, Cruz-Ramon J, Lin A. Agents used for treatment of hyperkeratosis. In: Wolverton SE. Comprehensive Dermatologic Drug Therapy. Philadelphia, PA: WB Saunders Co; 2001:671–684.

8 Mills OH Jr, Kligman AM. Is sulfur helpful or harmful in acne vulgaris? Br J Dermatol. 1972;86:620–627.

9 Strauss JS, Goldman PH, Nacht S, et al. A re-examination of the potential comedogenicity of sulfur. Arch Dermatol. 1978;114:1340–1342.

10 Physician’s Desk Reference. Montvale, NJ: Thomson PDR; 2003.

11 HEALTHPOINT launches new Ovace wash for seborrheic dermatitis on the face. [press release]. Available at: http://healthpoint.com/content/dermmain.htm. Accessed January 7, 2004.

12 Carmol Scalp Treatment kit. Available at: http://www.bradphar.com/carmolscalp.htm. Accessed February 11, 2004.

13 Clenia promotional materials provided by Upsher-Smith Laboratories, Maple Grove, MN, 2003.

14 Clenia Foaming Wash and Emollient Cream. Available at: http://www.upsher-smith.com/products/cleniaintro.html. Accessed January 7, 2004.

15 Klaron (sodium sulfacetamide) lotion, 10%. Available at: http://www.dermik.com/prod/klaron/Klaron.jsp. Accessed January 7, 2004.

16 Griffiths CEM. Nicotinamide 4% gel for the treatment of inflammatory acne vulgaris. J Derm Treat. 1995;6(suppl 1):S8–S10.

17 Plexion cleanser. Available at: http://plexion.com/p_home.html. Accessed January 7, 2004.

18 Rosanil (sodium sulfacetamide 10%, sulfur 5%) cleanser product information. Available at: http://www.rosanil.com. Accessed January 7, 2004.

19 Rosula product information. Available at: http://www.doakderm.com/rosula.htm. Accessed January 7, 2004.

20 Sulfoxyl lotion regular and Sulfoxyl lotion strong product descriptions. Available at: http://www.stiefel.com/USA/productdescriptions/Sulfoxyl%20Lotion.htm. Accessed January 7, 2004.

21 Zetacet promotional materials provided by Stiefel Laboratories, Coral Gables, FL, 2003.

REFERENCES


Sulfur/Sodium Sulfacetamide Preparations

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