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
Sponsored by
About this trial
This is an interventional prevention trial for Allergic Contact Dermatitis
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.
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
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.
Time Frame
Five days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
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
We'll reach out to this number within 24 hrs