Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Epidemiology and Co-Reactivity of Novel Surfactant Allergens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02534441
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Erin Warshaw, Minneapolis Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE August 6, 2015
First Posted Date  ICMJE August 27, 2015
Last Update Posted Date September 26, 2016
Study Start Date  ICMJE August 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2015)
Number of participants with positive skin patch test reaction, scored using the North American Contact Dermatitis Group (NACDG) criteria, to three novel surfactant antigens. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02534441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epidemiology and Co-Reactivity of Novel Surfactant Allergens
Official Title  ICMJE Epidemiology and Co-Reactivity of Novel Surfactant Allergens
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Allergic Contact Dermatitis
Intervention  ICMJE Other: Skin patch test
Study Arms  ICMJE Experimental: Skin patch testing to 6 known and 3 novel surfactants
Intervention: Other: Skin patch test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2016)
48
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2015)
100
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02534441
Other Study ID Numbers  ICMJE 4596-A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erin Warshaw, Minneapolis Veterans Affairs Medical Center
Study Sponsor  ICMJE Minneapolis Veterans Affairs Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Minneapolis Veterans Affairs Medical Center
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP