Epidemiology and Co-Reactivity of Novel Surfactant Allergens

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02534441

Enrollment

Registered

2015-08-27

Start date

2015-08-31

Completion date

2016-09-30

Last updated

2016-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Contact Dermatitis

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.

Interventions

OTHERSkin patch test

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026