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Epidemiology and Co-Reactivity of Novel Surfactant Allergens

Primary Purpose

Allergic Contact Dermatitis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Skin patch test

About this trial

This is an interventional prevention trial for Allergic Contact Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Skin patch testing to 6 known and 3 novel surfactants

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02534441

First Posted

August 6, 2015

Last Updated

September 22, 2016

Sponsor

Minneapolis Veterans Affairs Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02534441

Brief Title

Epidemiology and Co-Reactivity of Novel Surfactant Allergens

Official Title

Epidemiology and Co-Reactivity of Novel Surfactant Allergens

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minneapolis Veterans Affairs Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Contact Dermatitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Skin patch testing to 6 known and 3 novel surfactants

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Skin patch test

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Five days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

Epidemiology and Co-Reactivity of Novel Surfactant Allergens

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