Epidemiology and Co-Reactivity of Novel Surfactant Allergens

NCT ID: NCT02534441

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-09-30

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.

Conditions

Allergic Contact Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Skin patch testing to 6 known and 3 novel surfactants

Group Type: EXPERIMENTAL

Skin patch test

Intervention Type: OTHER

Interventions

Skin patch test

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Erin Warshaw

M.D., M.S.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

4596-A

Identifier Type: -

Identifier Source: org_study_id