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Contact sensitivity in patients with leg ulcerations 1
P253
P255
THE CUMULATIVE IRRITATION POTENTIAL OF ADAPALENE CREAM AND GEL 0.1% COMPARED TO TAZAROTENE CREAMS, 0.05% AND 0.1% AFTER REPEATED APPLICATIONS TO THE SKIN OF HEALTHY SUBJECTS Jonathan S Dosik, MD, TKL Research Inc, Paramus, NY, United States, Ste´phanie Arsonnaud Objective: To assess the cumulative irritation potential of adapalene cream and gel, 0.1% compared to tazarotene cream, 0.05% and 0.1%. Methods: Single center, active- and negative-controlled, investigator blinded, intra-individual comparison with randomized applications. The 4 products and the negative control were randomly applied on the upper area of the back under occlusive conditions. There were twelve 24-hour applications and three 72-hour applications on weekend during 3 weeks. A White Petrolatum site served as a negative control. Skin reactions (erythema score ,,b other local reaction) were assessed 15 to 30 minutes after removal of products. The Mean Cumulative Irritation Index (MCII) was calculated for each product by averaging individual CII’s across subjects. Results: Thirty subjects were included. Four subjects discontinued the study. More females (90%) than males participated; the mean age was 50.9 and most of the subjects (87%) were of Caucasian origins. There was no significant difference of the MCII (p ⬎ 0.05) between adapalene cream, 0.1% (0.0598 ⫹ 0.1082) and adapalene gel, 0.1% (0.1805 ⫹ 0.4725). Both adapalene formulations were significantly less irritant (p ⬍ 0.01 & p ⬍ 0.05) compared to both tazarotene concentrations (cream 0.05%: 0.7989 ⫹ 0.5352; cream 0.1%: 1.1241 ⫹ 0.5383). Tazarotene cream, 0.05% was significantly (p ⬍ 0.01 & p ⬍ 0.05) less irritant than tazarotene cream, 0.1%. There was no significant difference in irritation between both adapalene formulations and white petrolatum (MCII: 0.0276 ⫹ 0.0480). Significant differences (p ⬍ 0.01 & p ⬍ 0.05) for irritation in favor of white petrolatum were demonstrated with both tazarotene concentrations. No AE were resported. Conclusions: The results of this stressful test clearly indicate that both adapalene gel and cream in a concentration of 0.1% are significantly less irritant than tazarotene cream in both concentrations of 0.05% and 0.1%. Adapalene should therefore be considered as the first line topical therapy in treating acne vulgaris.
EVALUATION OF MEDICAL GRADE TAPES FOR ATTRIBUTES IMPORTANT TO PREDICTIVE AND DIAGNOSTIC TESTING Stephens T Mark, Thomas J. Stephens & Associates, Inc., Carrollton, TX, United States, Otto Mills, PhD, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, United States, James Herndon, Jr., MD, Presbyterian Medical Center, Dalllas, TX, United States Testing for contact irritation or allergy whether predictive or diagnostic requires a patch assuring uniform exposure of the test material to the skin. The type of tape used for these tests varies from paper to polyethylene films. Although the literature has some reports on the attributes of selected tapes, we are not aware of a recent comparative study especially from the clinical testing point of view. We chose occlusive and semiocclusive types of tapes representing currently used ones and decided to focus on (1) stratum corneum interactions as measured by TEWL (2) adhesive comfort as measured by subjective and mechanical assessments (3) irritation potential assessed clinically and with macrophotographic techniques. Based on this series of tests it was possible to rank the attributes of tapes important to clinical testing. Disclosure not available at press time.
Disclosure not available at press time. Study granted by Galderma Inc
P254 CONTACT SENSITIVITY IN PATIENTS WITH LEG ULCERATIONS Liliana J Saap, MD, Boston University, Provdence, RI, United States, Simone Fahim, MD, Boston University, Provdence, RI, United States, Emily Arsenault, MD, Boston University, Provdence, RI, United States, Anita Pedvis-Leftick, MD, Boston University, Provdence, RI, United States Background: There have been a number of studies in Europe on contact sensitivity in patients with chronic leg ulcerations. The frequency of positive patch test results found in this patient population have ranged from 40% to 82.5%, and have involved one or multiple allergens. The prevalence of sensitization in patients with leg ulcers has not been studied in North America. Furthermore, many of the newer dressings and wound care products in the market have not been studied for contact sensitivity. Objectives: 1) To determine the prevalence of allergen sensitivity in patients with past or present leg ulcers in two North American study centers, 2) to include newer dressings and wound care products in the battery of allergens tested 3) to compare the frequency of these sensitivities to those studied in Europe, 4) to compare the frequency of the common allergens in the study with the North American Contact Dermatitis Group (NACDG) database and 5) to help delineate a standard battery of allergens for patch testing in North American patients Methods: Fifty-four patients with an active leg ulcer or a history of a previous ulceration were included in this study. The patients were patch tested to both the NACDG Standard series of 65 allergens, as well as, a comprehensive supplemental series of 52 allergens including topical medicaments, additional rubber accelerators, preservatives, vehicles, and wound dressings. Readings were done at 48 hours and either at 96 or 118 hours following the NACDG protocol. Results: 52% (28) of patients had multiple positive patch tests, while 11% (6) had one positive patch test and 37% (20) had no positive patch tests. The most common allergens were Balsam of Peru, bacitracin, fragrance mix, wood tar mix, carba mix, and nickel sulfate. When comparing these results to the NACDG, patients in our study had a higher incidence of contact sensitivity to Balsam of Peru, Bacitracin, fragrance mix, carba mix and propylene glycol. Duoderm CGF was the most allergenic dressing in our study group. Conclusion: There is a high incidence of positive patch tests in patients with past or current leg ulcerations. Our results were comparable to similar studies done in Europe. The incidence of the most common allergens in our patient population was higher than those seen in the NACDG. Using a modified leg ulcer series along with the standard NACG series is very important in treating patients with leg ulcers.
P256
Disclosure not available at press time.
Disclosure not available at press time.
MARCH 2004
USE OF AROMATHERAPY PRODUCTS IS ASSOCIATED WITH INCREASED RISK OF HAND DERMATITIS IN MASSAGE THERAPISTS Glen H. Crawford, MD, University of Pennsylvania, Philadelphia, PA, United States, Kenneth Katz, MD, University of Pennsylvania, Philadelphia, PA, United States, Elliot Ellis, MD, University of Pennsylvania, Philadelphia, PA, United States, William James, MD, University of Pennsylvania, Philadelphia, PA, United States Background: The use of therapeutic massage is rapidly gaining popularity. Additionally, there has been a growing trend in the use of “natural” remedies and aromatherapy products. Massage therapists face multiple exposures known to influence hand dermatitis, such as wet work, fragrance, dyes, detergents, latex, and other irritants and allergens found in massage oils, creams, and lotions. The prevalence and risk factors for hand dermatitis among massage therapists have never been studied. Objective: To determine the 12 month period prevalence of hand dermatitis among massage therapists in the greater Philadelphia region, to investigate a potential association between hand dermatitis and the use of aromatherapy products, and to study potential associations with other known risk factors for hand dermatitis. Design: Mailed survey. Results: The number of respondents was 364 (59%). The 12 month period prevalence of hand dermatitis in included subjects was 15% by self-reported criteria and 23% by a symptom-based method. In multivariate analysis, statistically significant independent risk factors for self-reported hand dermatitis included use of aromatherapy products in massage oils, lotions, or creams (OR, 3.27; 95% CI, 1.53-7.02; p ⬍ 0.01); and history of atopic dermatitis (OR, 8.06; 95% CI, 3.39-19.17; p ⬍ 0.01). Conclusions: This study demonstrated a markedly increased prevalence rate of hand dermatitis in a large population of massage therapists. In addition, statistically significant independent associations were found between the reporting of hand dermatitis and the use of aromatherapy products in massage oils, creams, or lotions, and having a history of atopic dermatitis. The risk of allergic contact dermatitis from essential oils in the occupational setting has been well-established. Massage therapists should be aware of the sensitizing potential of their oils and the possibility of personal and client adverse skin reactions. To lower this high prevalence of hand dermatitis in massage therapists, it may be useful to conduct an educational campaign regarding the hazards of aromatherapy products, the identification of individuals with atopic background for vocational guidance, and the implementation of proper hand care practices such as reduced frequency of hand washing, avoidance of detergents, and use of protective barrier gloves.
J AM ACAD DERMATOL
P67
P255
THE CUMULATIVE IRRITATION POTENTIAL OF ADAPALENE CREAM AND GEL 0.1% COMPARED TO TAZAROTENE CREAMS, 0.05% AND 0.1% AFTER REPEATED APPLICATIONS TO THE SKIN OF HEALTHY SUBJECTS Jonathan S Dosik, MD, TKL Research Inc, Paramus, NY, United States, Ste´phanie Arsonnaud Objective: To assess the cumulative irritation potential of adapalene cream and gel, 0.1% compared to tazarotene cream, 0.05% and 0.1%. Methods: Single center, active- and negative-controlled, investigator blinded, intra-individual comparison with randomized applications. The 4 products and the negative control were randomly applied on the upper area of the back under occlusive conditions. There were twelve 24-hour applications and three 72-hour applications on weekend during 3 weeks. A White Petrolatum site served as a negative control. Skin reactions (erythema score ,,b other local reaction) were assessed 15 to 30 minutes after removal of products. The Mean Cumulative Irritation Index (MCII) was calculated for each product by averaging individual CII’s across subjects. Results: Thirty subjects were included. Four subjects discontinued the study. More females (90%) than males participated; the mean age was 50.9 and most of the subjects (87%) were of Caucasian origins. There was no significant difference of the MCII (p ⬎ 0.05) between adapalene cream, 0.1% (0.0598 ⫹ 0.1082) and adapalene gel, 0.1% (0.1805 ⫹ 0.4725). Both adapalene formulations were significantly less irritant (p ⬍ 0.01 & p ⬍ 0.05) compared to both tazarotene concentrations (cream 0.05%: 0.7989 ⫹ 0.5352; cream 0.1%: 1.1241 ⫹ 0.5383). Tazarotene cream, 0.05% was significantly (p ⬍ 0.01 & p ⬍ 0.05) less irritant than tazarotene cream, 0.1%. There was no significant difference in irritation between both adapalene formulations and white petrolatum (MCII: 0.0276 ⫹ 0.0480). Significant differences (p ⬍ 0.01 & p ⬍ 0.05) for irritation in favor of white petrolatum were demonstrated with both tazarotene concentrations. No AE were resported. Conclusions: The results of this stressful test clearly indicate that both adapalene gel and cream in a concentration of 0.1% are significantly less irritant than tazarotene cream in both concentrations of 0.05% and 0.1%. Adapalene should therefore be considered as the first line topical therapy in treating acne vulgaris.
EVALUATION OF MEDICAL GRADE TAPES FOR ATTRIBUTES IMPORTANT TO PREDICTIVE AND DIAGNOSTIC TESTING Stephens T Mark, Thomas J. Stephens & Associates, Inc., Carrollton, TX, United States, Otto Mills, PhD, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, United States, James Herndon, Jr., MD, Presbyterian Medical Center, Dalllas, TX, United States Testing for contact irritation or allergy whether predictive or diagnostic requires a patch assuring uniform exposure of the test material to the skin. The type of tape used for these tests varies from paper to polyethylene films. Although the literature has some reports on the attributes of selected tapes, we are not aware of a recent comparative study especially from the clinical testing point of view. We chose occlusive and semiocclusive types of tapes representing currently used ones and decided to focus on (1) stratum corneum interactions as measured by TEWL (2) adhesive comfort as measured by subjective and mechanical assessments (3) irritation potential assessed clinically and with macrophotographic techniques. Based on this series of tests it was possible to rank the attributes of tapes important to clinical testing. Disclosure not available at press time.
Disclosure not available at press time. Study granted by Galderma Inc
P254 CONTACT SENSITIVITY IN PATIENTS WITH LEG ULCERATIONS Liliana J Saap, MD, Boston University, Provdence, RI, United States, Simone Fahim, MD, Boston University, Provdence, RI, United States, Emily Arsenault, MD, Boston University, Provdence, RI, United States, Anita Pedvis-Leftick, MD, Boston University, Provdence, RI, United States Background: There have been a number of studies in Europe on contact sensitivity in patients with chronic leg ulcerations. The frequency of positive patch test results found in this patient population have ranged from 40% to 82.5%, and have involved one or multiple allergens. The prevalence of sensitization in patients with leg ulcers has not been studied in North America. Furthermore, many of the newer dressings and wound care products in the market have not been studied for contact sensitivity. Objectives: 1) To determine the prevalence of allergen sensitivity in patients with past or present leg ulcers in two North American study centers, 2) to include newer dressings and wound care products in the battery of allergens tested 3) to compare the frequency of these sensitivities to those studied in Europe, 4) to compare the frequency of the common allergens in the study with the North American Contact Dermatitis Group (NACDG) database and 5) to help delineate a standard battery of allergens for patch testing in North American patients Methods: Fifty-four patients with an active leg ulcer or a history of a previous ulceration were included in this study. The patients were patch tested to both the NACDG Standard series of 65 allergens, as well as, a comprehensive supplemental series of 52 allergens including topical medicaments, additional rubber accelerators, preservatives, vehicles, and wound dressings. Readings were done at 48 hours and either at 96 or 118 hours following the NACDG protocol. Results: 52% (28) of patients had multiple positive patch tests, while 11% (6) had one positive patch test and 37% (20) had no positive patch tests. The most common allergens were Balsam of Peru, bacitracin, fragrance mix, wood tar mix, carba mix, and nickel sulfate. When comparing these results to the NACDG, patients in our study had a higher incidence of contact sensitivity to Balsam of Peru, Bacitracin, fragrance mix, carba mix and propylene glycol. Duoderm CGF was the most allergenic dressing in our study group. Conclusion: There is a high incidence of positive patch tests in patients with past or current leg ulcerations. Our results were comparable to similar studies done in Europe. The incidence of the most common allergens in our patient population was higher than those seen in the NACDG. Using a modified leg ulcer series along with the standard NACG series is very important in treating patients with leg ulcers.
P256
Disclosure not available at press time.
Disclosure not available at press time.
MARCH 2004
USE OF AROMATHERAPY PRODUCTS IS ASSOCIATED WITH INCREASED RISK OF HAND DERMATITIS IN MASSAGE THERAPISTS Glen H. Crawford, MD, University of Pennsylvania, Philadelphia, PA, United States, Kenneth Katz, MD, University of Pennsylvania, Philadelphia, PA, United States, Elliot Ellis, MD, University of Pennsylvania, Philadelphia, PA, United States, William James, MD, University of Pennsylvania, Philadelphia, PA, United States Background: The use of therapeutic massage is rapidly gaining popularity. Additionally, there has been a growing trend in the use of “natural” remedies and aromatherapy products. Massage therapists face multiple exposures known to influence hand dermatitis, such as wet work, fragrance, dyes, detergents, latex, and other irritants and allergens found in massage oils, creams, and lotions. The prevalence and risk factors for hand dermatitis among massage therapists have never been studied. Objective: To determine the 12 month period prevalence of hand dermatitis among massage therapists in the greater Philadelphia region, to investigate a potential association between hand dermatitis and the use of aromatherapy products, and to study potential associations with other known risk factors for hand dermatitis. Design: Mailed survey. Results: The number of respondents was 364 (59%). The 12 month period prevalence of hand dermatitis in included subjects was 15% by self-reported criteria and 23% by a symptom-based method. In multivariate analysis, statistically significant independent risk factors for self-reported hand dermatitis included use of aromatherapy products in massage oils, lotions, or creams (OR, 3.27; 95% CI, 1.53-7.02; p ⬍ 0.01); and history of atopic dermatitis (OR, 8.06; 95% CI, 3.39-19.17; p ⬍ 0.01). Conclusions: This study demonstrated a markedly increased prevalence rate of hand dermatitis in a large population of massage therapists. In addition, statistically significant independent associations were found between the reporting of hand dermatitis and the use of aromatherapy products in massage oils, creams, or lotions, and having a history of atopic dermatitis. The risk of allergic contact dermatitis from essential oils in the occupational setting has been well-established. Massage therapists should be aware of the sensitizing potential of their oils and the possibility of personal and client adverse skin reactions. To lower this high prevalence of hand dermatitis in massage therapists, it may be useful to conduct an educational campaign regarding the hazards of aromatherapy products, the identification of individuals with atopic background for vocational guidance, and the implementation of proper hand care practices such as reduced frequency of hand washing, avoidance of detergents, and use of protective barrier gloves.
J AM ACAD DERMATOL
P67