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.

Study Overview

• Status: Completed
• Conditions: Allergic Contact Dermatitis
• Intervention / Treatment: Other: Skin patch test

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Minneapolis Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 6, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Estimate): September 26, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
• Other Study ID Numbers: 4596-A