Epidemiology and Co-Reactivity of Novel Surfactant Allergens

Study Overview
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Brief Summary
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The primary objectives of this study are to identify positivity rates to three novel surfactants (ingredients used in soaps, detergents, and other cleansers that serve to lower the surface tension of the skin and remove debris) and co-reactivity with other surfactants in patients with known surfactant sensitivity on skin patch testing. The investigators hypothesize that subjects who previously tested positive to known allergenic surfactants (cocamidopropyl betaine, stearamidopropyl dimethylamine, dimethylaminopropylamine, coconut diethanolamide, oleamidopropyl dimethylamine, and decyl glucoside) may demonstrate co-reactivity to the three novel surfactant sensitizers (sodium lauroyl sarcosinate, isostearmidopropyl morpholine lactate, and disodium lauroamphodiacetate) on skin patch testing.

Official Title
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Epidemiology and Co-Reactivity of Novel Surfactant Allergens

Conditions
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Allergic Contact Dermatitis

Intervention / Treatment
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* Other: Skin patch test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documentation of a previous contact allergy to one or more surfactant(s) on our screening series including: cocamidopropyl betaine stearamidopropyl dimethylamine dimethylaminopropylamine coconut diethanolamide oleamidopropyl dimethylamine, and decyl glucoside Age 18 years or greater. Exclusion Criteria: Pregnant or lactating women Use of systemic therapy (corticosteroid, immunosuppressive agents, cytostatics, pentoxifylline, leukotriene antagonists or other medication known or suspected to have an effect of ACD) within two weeks prior to participation Use of intramuscular steroids in the last month. Phototherapy (PUVA or UVB) within two weeks prior to participation. Direct sunlight or tanning booth use to the back within the two weeks prior to participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin patch testing to 6 known and 3 novel surfactants<br> | Other: Skin patch test<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with positive skin patch test reaction, scored using the North American Contact Dermatitis Group (NACDG) criteria, to three novel surfactant antigens. | NACDG Scoring as follows: 6=no reaction, 4=doubtful (faint erythema with no induration), 1= mild (erythema, induration, +/- papules), 2=moderate (erythema, induration, papules, vesicles), 3=severe (intense erythema, induration, coalescing vesicles, bullae, spreading), and 5= irritant. | Five days |