United States, Bruce Kohut, DMD, Pfizer Inc, Morris Plains, NJ, United States. The objective of this controlled, clinical study was to determine the incidence of ...
Dermatitis, Contact & Allergic Irritant P249 HOW DOES THE DIAGNOSIS OF LATEX ALLERGY AFFECT PEOPLE’S LIVES? Victoria J Lewis, MBBS, University Hospital of Wales, Cardiff, Wales, Barry Statham, MBBS, Singleton Hospital, Swansea, Wales, Mabs Chowdhury, MBBS, University Hospital of Wales, Cardiff, Wales 50 patients who had been diagnosed with latex allergy in the past 6 years in Swansea and Cardiff were sent a questionnaire about how their lives had changed following their diagnosis. They also completed the Dermatology Life Quality Index on symptoms before and after their diagnosis. 36 patients responded (72%), 22 of whom worked in the healthcare service. 9 had changed the nature of their job since diagnosis. Of the 26 people regularly working with latex 21 employers had assisted them with these changes. However 1/3 who visited their doctor or dentist since diagnosis had encountered ill-informed staff, some patients even having to supply their own gloves. 14 out of 36 had a food allergy, the commonest being to bananas or kiwi fruit. The commonest reported symptoms were urticaria (17/36), chronic hand dermatitis (11/36) and angioedema (13/36). Most staff switching to latex free gloves noticed an improvement in their symptoms, and average DLQI scores reduced from 18 to 11 following diagnosis, although this was in retrospect. In this study the patients questioned had experienced symptoms for up to 10 years before diagnosis. It highlights the importance of early diagnosis, both to improve quality of life and avoid problems in the workplace. It also exposes the lack of knowledge still prsent in medical staff about this condition. Disclosure not available at press time.
P251 DETERMINATION OF INCIDENCE OF DERMAL SENSITIZATION TO A TOPICAL TRIPLE ANTIBIOTIC OINTMENT IN A NORMAL HEALTHY POPULATION Rita A Wanser, BS, Pfizer Inc, Morris Plains, NJ, United States, Kays Kaidbey, MD, Pfizer Inc, Morris Plains, NJ, United States, James Leyden, MD, Pfizer Inc, Morris Plains, NJ, United States, Bruce Kohut, DMD, Pfizer Inc, Morris Plains, NJ, United States The objective of this controlled, clinical study was to determine the incidence of dermal sensitization to a topical triple antibiotic ointment (TAO) containing Neomycin, Bacitracin and Polymyxin B in a generally normal healthy population that had potential to prior exposure to this ointment, when tested under 48 hours of semi occlusive patch test conditions. This study was a multicenter, randomized, evaluator blind, single patch application. A vehicle control treatment (petroleum) was included to determine potential subject reaction to the base and a negative control (distilled water) was used to verify reliability of the methodology and determine potential subject hypersensitivity to patching/patch wear. Sensitization was assessed by evaluating the response at 24 and 48 hours post patch removal using the 5-point grading system recommended by the International Contact Dermatitis Research Group and the North American Contact Dermatitis group. Dermal irritation was assessed using a 6-point scale. Of the total of 512 healthy subjects who qualified for the study, over 500 subjects completed the study. Except for a transient upper respiratory infection or headache in a few subjects, no significant adverse events were encountered. No significant primary irritant reactions were encountered. Three of the completing subjects developed raised pruritic spreading reactions at the site of the TAO and these reactions were suggestive of delayed contact hypersensitivity. All three subjects reported prior exposure to TAO. Therefore, based on the results of this study, the incidence of delayed contact hypersensitivity to TAO in a normal healthy population is less than 1.0%. Primary and co presenter #3 are Pfizer employees. 100% is sponsored by Pfizer Consumer Health Care
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THE USE OF CLOBETASOL .05% FOAM IN THE TREATMENT OF CHRONIC HAND DERMATITIS J. Mark Jackson, MD, University of Louisville Div of Dermatology, Louisville, KY, United States, Joseph F. Fowler Jr., MD, University of Louisville Div of Dermatology, Louisville, KY, United States The goal of this double-blind randomized placebo controlled study is to determine the effectiveness of the topical corticosteroid Clobetasol propionate in a foam vehicle 0.05% in the treatment of hand dermatitis including allergic and irritant contact dermatitis, atopic dermatitis and endogenous dermatitis. The study will also determine the impact on quality of life issues associated with the dermatitis as well as with the aesthetics of the vehicle compared to previous topical lotions, creams, gels and ointments. Thirty patients (10 placebo and 20 active agent) will be enrolled and will apply placebo or vehicle twice daily for two weeks. Evaluations will be performed at baseline 2 weeks and 2 weeks post treatment. Global assessments and patient evaluations will be performed at baseline and two week post treatment.
DETERMINATION OF THE CUMULATIVE IRRITATION POTENTIAL OF ADAPALENE CREAM AND GEL 0.1% COMPARED TO TRETINOIN MICRO, 0.04% AND MICRO, 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, Galderma R&D Inc, Princeton, NY, United States Objective: To assess the cumulative irritation potential of adapalene cream and gel, 0.1% compared to tretinoin micro gel, 0.04% 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 ⫾ 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-one subjects were included. Five subjects withdrew from the study More than 90% of the subjects were females with a mean age of 39.7 years and more than 77% were of Caucasian origins There was no significant difference for the MCII between adapalene gel (0.0471 ⫹ 0.1460) and cream (0.0920 ⫹ 0.1647). Significant differences were shown (p ⬍ 0.01 and p ⬍ 0.05) between both adapalene concentrations and both tretinoin concentrations (gel micro 0.04%: 0.7138 ⫹ 0.4593; gel micro 0.1%: 0.6747 ⫹ 0.4178). There was no significant difference between both adapalene formulations and white petrolatum (0.0126 ⫹ 0.0681) but significant differences (p ⬍ 0.01 and p ⬍ 0.05) between white petrolatum and both retinoin concentrations. There were no adverse events reported. Conclusions: The results of this stressful test clearly indicate that a concentration of 0.1% of adapalene in a gel or a cream formulation is well tolerated as compared to tretinoin. The results of this study showed that adapalene should be considered as the first line topical therapy for treating acne vulgaris.
Disclosure not available at press time. Study was sponsored wholly by Connetics corporation
Disclosure not available at press time. Study granted by Galderma Inc
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J AM ACAD DERMATOL
MARCH 2004
