Epidemiology and Co-Reactivity of Novel Surfactant Allergens

• Sponsor: Minneapolis Veterans Affairs Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02534441
• Collaborator: (none)
• Enrollment: 48
• Arm: 1
• Duration (Months): 13

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Contact Dermatitis	Other: Skin patch test	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Epidemiology and Co-Reactivity of Novel Surfactant Allergens
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

1. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Minneapolis Veterans Affairs Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erin Warshaw, M.D., M.S., Minneapolis Veterans Affairs Medical Center
• ClinicalTrials.gov Identifier: NCT02534441
• Other Study ID Numbers: 4596-A
• First Posted: Aug 27, 2015
• Last Update Posted: Sep 26, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact

Study Results

No Results Posted as of Sep 26, 2016