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Epidemiology and Co-Reactivity of Novel Surfactant Allergens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02534441
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : September 26, 2016
Information provided by (Responsible Party):
Erin Warshaw, Minneapolis Veterans Affairs Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Allergic Contact Dermatitis Other: Skin patch test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Epidemiology and Co-Reactivity of Novel Surfactant Allergens
Study Start Date : August 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Skin patch testing to 6 known and 3 novel surfactants Other: Skin patch test

Primary Outcome Measures :
  1. Number of participants with positive skin patch test reaction, scored using the North American Contact Dermatitis Group (NACDG) criteria, to three novel surfactant antigens. [ Time Frame: Five days ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 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
  2. Age 18 years or greater.

Exclusion Criteria:

  1. Pregnant or lactating women
  2. 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
  3. Use of intramuscular steroids in the last month.
  4. Phototherapy (PUVA or UVB) within two weeks prior to participation.
  5. Direct sunlight or tanning booth use to the back within the two weeks prior to participation.

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Responsible Party: Erin Warshaw, M.D., M.S., Minneapolis Veterans Affairs Medical Center Identifier: NCT02534441    
Other Study ID Numbers: 4596-A
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Immune System Diseases
Pulmonary Surfactants
Respiratory System Agents