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OpenTrials
Completed

NCT Number: NCT02534441

Epidemiology and Co-Reactivity of Novel Surfactant Allergens

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.

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Key information

Conditions

Allergic Contact Dermatitis Dermatitis Dermatitis, Allergic Contact Dermatitis, Contact Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skin patch test

Other

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Minneapolis Veterans Affairs Medical Center

Fed

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 27, 2015
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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