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Efficacy and safety of pimecrolimus cream 1% in mild-to-moderate chronic hand dermatitis: a randomized, double-blind trial

Hordinsky, Maria; Fleischer, Alan; Rivers, Jason K; Poulin, Yves; Belsito, Donald; Hultsch, Thomas
BACKGROUND:Chronic hand dermatitis is common and difficult to treat. OBJECTIVE:Our aim was to assess the efficacy of pimecrolimus cream 1% in mild-to-moderate chronic hand dermatitis. METHODS:Adult patients (n = 652) were randomized to pimecrolimus 1% or vehicle cream twice daily with overnight occlusion for 6 weeks, followed by a 6-week open-label pimecrolimus treatment. Primary efficacy was 5-point Investigators' Global Assessment of prospectively selected 'target hand' as treatment success (Investigators' Global Assessment 0 or 1) and treatment failure. Pruritus relief was also assessed. RESULTS:Following double-blind phase treatment, target hand treatment success was achieved in 29.8 and 23.2% of the patients in the pimecrolimus and vehicle groups, respectively (p = 0.057). The proportion of patients experiencing pruritus relief was significantly higher in the pimecrolimus group compared to the vehicle group at all time points throughout the double-blind phase. CONCLUSION/CONCLUSIONS:The groups were comparable with respect to treating disease signs. Pruritus relief, however, was significantly greater in the pimecrolimus group.
PMID: 20693804
ISSN: 1421-9832
CID: 5642532

Quantitative risk assessment of contact sensitization: clinical data to assess utility of the model

Marie Api, Anne; Belsito, Donald; Bickers, David; Bruze, Magnus; Calow, Peter; Greim, Helmut; Hanifin, Jon M; McNamee, Pauline M; Rogers, Adrianne E; Saurat, Jean-Hilaire; Sipes, I Glenn; Tagami, Hachiro
BACKGROUND:Contact hypersensitivity quantitative risk assessment (QRA) for fragrance ingredients is being used to establish new international standards for all fragrance ingredients that are potential skin sensitizers. OBJECTIVE:The objective was to evaluate the retrospective clinical data on three fragrance ingredients in order to provide a practical assessment of the predictive value of the QRA approach. It is important to have data to assess that the methodology provides a robust approach for primary prevention of contact sensitization induction for fragrance ingredients identified as potential sensitizers. METHODS:This article reviews clinical data for three fragrance ingredients-cinnamic aldehyde, citral, and isoeugenol-to assess the utility of the QRA approach for fragrance ingredients. RESULTS:This assessment suggests that had the QRA approach been available at the time standards were established for these fragrance ingredients, the clinical response might have been noticeably improved. Prospectively, with the establishment of QRA-derived standards, there should be a continued downward trend in patch test-positive rates for cinnamic aldehyde, citral, and isoeugenol over time. CONCLUSION/CONCLUSIONS:While it is recognized that the availability of retrospective data is limited, a longitudinal review of these data gives confidence that the QRA approach should be an effective tool for primary prevention. This study also highlights the importance of continued active monitoring of clinical patch-test data for fragrance ingredients.
PMID: 20646672
ISSN: 2162-5220
CID: 5642522

Positive patch-test reactions to iodopropynyl butylcarbamate: retrospective analysis of North American contact dermatitis group data, from 1998 to 2008

Warshaw, Erin M; Boralessa Ratnayake, Dilangani; Maibach, Howard I; Sasseville, Denis; Belsito, Donald V; Zug, Kathryn A; Fowler, Joseph F; Taylor, James S; Toby Mathias, C G; Fransway, Anthony F; Deleo, Vincent A; Marks, James G; Storrs, Frances J; Pratt, Melanie D; Rietschel, Robert L
BACKGROUND:iodopropynyl butylcarbamate (IPBC), a commonly used preservative, is found in industrial and personal care products. OBJECTIVE:to evaluate prevalence, clinical relevance, occupational relationship, and sources of positive reactions to IPBC in patients in North America. METHODS:the North American Contact Dermatitis Group (NACDG) tested IPBC 0.1% and/or 0.5% in petrolatum (pet) between 1998 and 2008. Two patient groups of interest were defined, based on patch-test reactions to IPBC: weak (+) reactors and strong (++ or +++) reactors. Patient characteristics, site(s) of dermatitis, sources of positive reactions, clinical relevance, and occupational relevance to IPBC were tabulated. RESULTS:of the 25,321 patients tested, there were 226 (0.9%) weak reactors and 67 (0.3%) strong reactors. For IPBC-positive patients, the most frequent sites of dermatitis were scattered generalized distribution, hands, and arms. The majority (> 50%) of currently relevant reactions were to personal care products, and most reactions (> 90%) were not related to occupation. Only four of the strong reactors had definite clinical relevance (positive use-test reaction or positive patch-test reaction to a product containing IPBC). The frequency of positive reactions increased (0.2% vs 1.5%) when the higher concentration of IPBC was utilized, but most (> 64%) were weak reactions, of which some were likely irritant. CONCLUSIONS:allergy to IPBC is relatively uncommon. When clinically relevant, personal care products were the most likely allergen source. Because IPBC is a marginal irritant, caution should be utilized when testing with higher concentrations of IPBC (≥ 0.5% pet) and when interpreting weak (+) reactions. Verification of clinical relevance by use test or repeat patch testing or both is also important.
PMID: 21144341
ISSN: 2162-5220
CID: 5642542

Patch testing with methyldibromoglutaronitrile in a localized population in the United States

Javvaji, Srimanasi; Belsito, Donald V
BACKGROUND:in Europe, methyldibromoglutaronitrile (MDGN) was banned because of excessive rates of contact allergy. However, it is unclear whether the concentrations used for testing MDGN are optimal, as different groups have used varying concentrations with quite different rates of positive reactions. OBJECTIVES/OBJECTIVE:to report patch-test results with MDGN in a localized US population, to compare these results with those of other studies, and to evaluate any association between contact allergy to MDGN and atopic dermatitis. METHODS:a retrospective analysis of 1,753 patients tested with various concentrations of MDGN was conducted. RESULTS:Four percent (4.0%) of patients had positive reactions to MDGN, of which 1.2% were ++/+++ reactions and 2.8% were + reactions. Among patients with ++/+++ reactions, 9.5% had a reaction of definite relevance; of patients with + reactions, only 2.0% had a reaction of definite relevance. Irritant reactions were had by 3.2% of patients; none of these were relevant. The North American Contact Dermatitis Group had a positive reaction rate of 6.2%; European groups had rates of 1.6 to 5.0%. No significant association was found between atopic dermatitis and positive patch-test reactions to MDGN. CONCLUSION/CONCLUSIONS:owing to the number of irritant reactions observed, we suspect that many reactions to MDGN are falsely positive, underscoring the importance of careful interpretation of reactions less than or equal to +.
PMID: 21144344
ISSN: 2162-5220
CID: 5642552

Detection of nickel sensitivity has increased in North American patch-test patients

Rietschel, Robert L; Fowler, Joseph F; Warshaw, Erin M; Belsito, Donald; DeLeo, Vincent A; Maibach, Howard I; Marks, James G; Mathias, C G Toby; Pratt, Melanie; Sasseville, Denis; Storrs, Frances J; Taylor, James S; Zug, Kathryn A
BACKGROUND:Nickel allergy has been studied by contact dermatitis groups around the world, and the frequency of nickel sensitivity has been reported to be decreasing in some populations. OBJECTIVE:To review the prevalence of nickel allergy as observed by the North American Contact Dermatitis Group from 1992 to 2004. METHODS:The computer database of the North American Contact Dermatitis Group was used to examine the prevalence of nickel allergy over the study period and to analyze it by time, sex, and age. RESULTS:From 1992 to 2004, 25,626 patients were patch-tested. The percentage of women tested was fairly constant (61.4-66.3%). A steady increase in nickel sensitivity was seen from 1992 to 2004. Subgroup analysis did not identify a population with declining nickel allergy. CONCLUSIONS:Nickel allergy continues to increase in younger and older men and women patch-tested in North America.
PMID: 18346391
ISSN: 1710-3568
CID: 5642502