Epidemiology and Co-Reactivity of Novel Surfactant Allergens

Allergic Contact Dermatitis Clinical Trial

Official title:

Epidemiology and Co-Reactivity of Novel Surfactant Allergens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534441
• Other study ID #: 4596-A
• Status: Completed
• Phase: N/A
• First received: August 6, 2015
• Last updated: September 22, 2016
• Start date: August 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact

Intervention

Other:
• Skin patch test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No