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- W2064599134 abstract "The objective of this single-center, investigator-blinded study involving 157 randomized, healthy patients was to determine the dermal safety of a new 10% sodium sulfacetamide and 5% sulfur cleanser, compared with (10% sodium sulfacetamide and 5% sulfur) and 0.2% sodium lauryl sulfate (SLS). This study involved 3 phases. In the first phase, induction/irritation, the cleansers in 8% dilution and SLS were applied under separate semi-occlusive patches on the backs of subjects 3 times per week for 3 weeks. Each application remained on the skin for 8 hours, after which the patient washed it off. The test sites were observed 48 hours later (72 hours on weekends) for signs of irritation or inflammation. The second phase involved a rest period of 10 to 14 days, during which no patches were applied. During the third challenge phase, the cleansers were applied to new sites on the back for 48 hours. After patch removal, the sites were observed for signs of sensitization. Very few reactions were observed with any of the test products. There were no observed cases of contact sensitization, and there were only rare incidences of mild irritant reactions. 10% sodium sulfacetamide and 5% sulfur cleanser cleanser was not associated with any signs of irritation. 10% sodium sulfacetamide and 5% sulfur cleanser is the first fragrance-free sulfacetamide/sulfur cleanser for use in patients with rosacea. This study demonstrates that this newest cleanser has a very low potential for irritation or sensitization. Introduction: Patients with rosacea frequently have exquisitely sensitive skin.1 Therefore, it is important to prescribe therapeutic cleansers for these patients to minimize skin irritation.2 Antimicrobial cleansers containing 10% sodium sulfacetamide and 5% sulfur constitute the newest category of therapeutic cleanser. There are several antimicrobial cleaners presently available. All these formulations contain sodium cocoyl isethionate as the major surfactant, have a slightly acidic to neutral pH, and lack the odor problems of older sulfur-containing formulations.3-5 A major difference between 10% sodium sulfacetamide and 5% sulfur cleanser and the other cleansers is that 10% sodium sulfacetamide and 5% sulfur cleanser lacks fragrances3-5 that can cause skin irritation.1 Study design: The objective of this study was to assess dermal safety of a 10% sodium sulfacetamide and 5% sulfur cleanser by determining the cumulative irritation and contact hypersensitivity. This was a single-center, investigator-blinded study involving 157 randomized, healthy patients. Twenty patients dropped out before study completion. The dermal safety of 10% sodium sulfacetamide and 5% sulfur cleanser was compared with that of (10% sodium sulfacetamide and 5% sulfur) and 0.2% sodium lauryl sulfate (SLS). This low-dose SLS was used as a control. This study involved 3 phases. In the first phase, induction/irritation, the cleansers in 8% dilution and SLS were applied under separate semi-occlusive patches on the backs of subjects 3 times per week for 3 weeks. Each application remained on the skin for 8 hours, after which the patient washed it off. The test sites were observed 48 hours later (72 hours on weekends) for signs of irritation or inflammation. The second phase involved a rest period of 10 to 14 days during which no patches were applied. During the third challenge phase, the cleansers were applied to new sites on the back for 48 hours. After patch removal, the sites were observed for signs of sensitization. A 6-point grading scale was used to assess skin irritation (Table 1). Table 1Grading System for Skin Irritation0No sign of irritation0.5Barely perceptible erythema1Slight erythema2Noticeable erythema with slight infiltration3Erythema with marked edema4Erythema with edema and blistering Open table in a new tab Results: Very few irritant or sensitization reactions were observed with any of the test products. There were no observed cases of contact sensitization and there were only rare incidences of mild irritant reactions. 10% sodium sulfacetamide and 5% sulfur cleanser was not associated with any signs of irritation during either the induction or challenge phases (Table 2). During the induction phase, 10% sodium sulfacetamide and 5% sulfur) and 0.2% sodium lauryl sulfate (SLS) was associated with a few reactions (Table 3). One subject experienced barely perceptible erythema at day 22. Another subject experienced erythema with edema and blistering on day 4. When the patch was moved, the original patch site improved, showing noticeable erythema with slight infiltration on day 8. This reaction resolved by day 22. During the challenge phase, one subject receiving 10% sodium sulfacetamide and 5% sulfur) and 0.2% sodium lauryl sulfate (SLS) evidenced noticeable erythema with slight infiltration. However, a repeat challenge did not produce any reactions. Subjects receiving SLS did not show any reactions during the induction phase. This was expected, since this low-dose SLS served as a positive control. SLS was not used during the challenge phase.Table 2Irritant Reactions With 10% sodium sulfacetamide and 5% sulfurcleanser During the Induction Phase (N = 137)Score00.51234Number of subjects0000000 Open table in a new tab Table 3Irritant Reactions With Plexion Cleanser During the Induction Phase (N = 137)Score00.51234Number of subjects11 Open table in a new tab Conclusion: 10% sodium sulfacetamide and 5% sulfur cleanser is the first fragrance-free sodium sulfacetamide/sulfur cleanser for use in patients with rosacea. This study demonstrates that this newest antimicrobial cleanser has a very low potential for irritation or sensitization. Sodium sulfacetamide/sulfur cleansers are a well-tolerated therapeutic adjunct for patients with rosacea." @default.
- W2064599134 created "2016-06-24" @default.
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- W2064599134 date "2004-03-01" @default.
- W2064599134 modified "2023-09-27" @default.
- W2064599134 title "Dermal tolerability and safety of a fragrance-free sulfacetamide/sulfur cleanser" @default.
- W2064599134 doi "https://doi.org/10.1016/j.jaad.2003.10.213" @default.
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