Epidemiology and Co-Reactivity of Novel Surfactant Allergens

Not Applicable

Completed

• Conditions: Allergic Contact Dermatitis
• Interventions: Other: Skin patch test

• Registration Number: NCT02534441
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-27
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skin patch testing to 6 known and 3 novel surfactants	Skin patch test	-

Primary Outcome Measures

Name	Time	Method
Number of participants with positive skin patch test reaction, scored using the North American Contact Dermatitis Group (NACDG) criteria, to three novel surfactant antigens.	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.