Epidemiology and Co-Reactivity of Novel Surfactant Allergens

NCT02534441 | Completed

• 1 other identifier: 4596-A
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (1)

Skin patch testing to 6 known and 3 novel surfactants

EXPERIMENTAL

Other: Skin patch test

Interventions

Skin patch test OTHER

Skin patch testing to 6 known and 3 novel surfactants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.S.

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 27, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 26, 2016

Record last verified: 2016-09