Back to resultsBioequivalence of Ethylenediamine Dihydrochloride Study
Primary Purpose
Allergic Contact Dermatitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ethylenediamine dihydrochloride allergen patch
Sponsored by
About this trial
This is an interventional health services research trial for Allergic Contact Dermatitis focused on measuring ethylenediamine dihydrochloride
Eligibility Criteria
Inclusion Criteria:
- Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 10 years) to ethylenediamine dihydrochloride
- 18 years of age or older, otherwise in good health
- Female subjects of childbearing potential must consent to a urine pregnancy test; results must be negative for study inclusion.
- Informed consent signed and understood by each subject.
Exclusion Criteria:
- Subjects unable to meet inclusion requirements
- Women who are breastfeeding or pregnant
- Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area
- Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents
- Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks
- Acute dermatitis outbreak or dermatitis on or near the test area on the back
- Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity)
- Subject participation in clinical trials of investigational drugs, treatments, or devices, other than T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in this study
Sites / Locations
- Dermatology Specialists PSC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ethylenediamine dihydrochloride
Arm Description
Ethylenediamine dihydrochloride in methylcellulose 50 mcg/cm2 Ethylenediamine dihydrochloride in polyvinylpyrrolidone 50 mcg/cm2 Methylcellulose (negative control 1) Polyvinylpyrrolidone (negative control 2)
Outcomes
Primary Outcome Measures
Number of Participants With Positive Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Bioequivalence will be calculated using concordance (Cohen's Kappa) between the number of subjects with positive reactions (defined as a score of 1+, 2+ or 3+) to 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) and 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and the number of subjects with negative reactions to 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) and 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone)
Secondary Outcome Measures
Number of Participants With Late Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Number of subjects with a late reaction, defined as a positive reaction (score of 1+, 2+, 3+) initially appearing at 7-21 days after patch application)
Number of Participants With Persistent Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Number of subjects with a persistent reaction, defined as a positive reaction (score of 1+, 2+, 3+) initially appearing at one visit and persisting through the following visit.
Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Skin irritation associated with the adhesive tape (tape irritation) used to secure the test patches was evaluated at Visit 2 (day 2) 20 minutes following panel removal according to the following Tape Adhesion Score Scale: None (no irritation), Weak (faint to definite pink erythema), Moderate (moderate erythema, definite redness), Strong (severe erythema, very intense redness). Entire panel was scored as a whole- individual allergen sites were not scored separately.
Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Subject self-report of itching attributed to the test panels was recorded at Visit 2 (day 2), 20 minutes following panel removal. The following Itching Score Scale was used: None (no itching), Weak (minimal discomfort), Moderate (definite discomfort), Strong (significantly bothersome, possible interference with sleep or daily activity). Entire panel was scored as a whole- individual allergen sites were not scored separately.
Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Subject self-report of burning attributed to the test panels was recorded at Visit 2 (day 2), 20 minutes following panel removal. The following Burning Score scale was used: None (no burning), Weak (minimal discomfort), Moderate (definite discomfort), Strong (significantly bothersome, possible interference with sleep or daily activity). Entire panel was scored as a whole- individual allergen sites were not scored separately.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01798589
Brief Title
Bioequivalence of Ethylenediamine Dihydrochloride Study
Official Title
Clinical Evaluation of TRUE Test Ethylenediamine Dihydrochloride Allergen: Bioequivalence of Vehicle Formulations
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allerderm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.
Detailed Description
We propose an open, prospective, single-site study to evaluate the bioequivalence of ethylenediamine dihydrochloride in methylcellulose (MC)and polyvinylpyrrolidone (PVP) formulations. Bioequivalence will be determined in minimum of 15 adult subjects, with a clinical history of contact dermatitis and a positive patch test (current or previous) to ethylenediamine ("sensitives").
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Contact Dermatitis
Keywords
ethylenediamine dihydrochloride
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ethylenediamine dihydrochloride
Arm Type
Experimental
Arm Description
Ethylenediamine dihydrochloride in methylcellulose 50 mcg/cm2 Ethylenediamine dihydrochloride in polyvinylpyrrolidone 50 mcg/cm2 Methylcellulose (negative control 1) Polyvinylpyrrolidone (negative control 2)
Intervention Type
Drug
Intervention Name(s)
Ethylenediamine dihydrochloride allergen patch
Other Intervention Name(s)
T.R.U.E. Test allergen ethylenediamine dihydrochloride
Intervention Description
1 allergen panel containing 2 allergen and 2 control patches
Primary Outcome Measure Information:
Title
Number of Participants With Positive Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Description
Bioequivalence will be calculated using concordance (Cohen's Kappa) between the number of subjects with positive reactions (defined as a score of 1+, 2+ or 3+) to 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) and 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone) and the number of subjects with negative reactions to 50 mcg/cm2 Ethylenediamine dihydrochloride in MC (methylcellulose) and 50 mcg/cm2 Ethylenediamine dihydrochloride in PVP (polyvinylpyrrolidone)
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Number of Participants With Late Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Description
Number of subjects with a late reaction, defined as a positive reaction (score of 1+, 2+, 3+) initially appearing at 7-21 days after patch application)
Time Frame
Day 7-21
Title
Number of Participants With Persistent Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Description
Number of subjects with a persistent reaction, defined as a positive reaction (score of 1+, 2+, 3+) initially appearing at one visit and persisting through the following visit.
Time Frame
Day 3-21
Title
Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Description
Skin irritation associated with the adhesive tape (tape irritation) used to secure the test patches was evaluated at Visit 2 (day 2) 20 minutes following panel removal according to the following Tape Adhesion Score Scale: None (no irritation), Weak (faint to definite pink erythema), Moderate (moderate erythema, definite redness), Strong (severe erythema, very intense redness). Entire panel was scored as a whole- individual allergen sites were not scored separately.
Time Frame
Day 2 (48 hours after application)
Title
Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Description
Subject self-report of itching attributed to the test panels was recorded at Visit 2 (day 2), 20 minutes following panel removal. The following Itching Score Scale was used: None (no itching), Weak (minimal discomfort), Moderate (definite discomfort), Strong (significantly bothersome, possible interference with sleep or daily activity). Entire panel was scored as a whole- individual allergen sites were not scored separately.
Time Frame
Day 2 (48 hours after patch application)
Title
Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
Description
Subject self-report of burning attributed to the test panels was recorded at Visit 2 (day 2), 20 minutes following panel removal. The following Burning Score scale was used: None (no burning), Weak (minimal discomfort), Moderate (definite discomfort), Strong (significantly bothersome, possible interference with sleep or daily activity). Entire panel was scored as a whole- individual allergen sites were not scored separately.
Time Frame
Day 2 (48 hours after application)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 10 years) to ethylenediamine dihydrochloride
18 years of age or older, otherwise in good health
Female subjects of childbearing potential must consent to a urine pregnancy test; results must be negative for study inclusion.
Informed consent signed and understood by each subject.
Exclusion Criteria:
Subjects unable to meet inclusion requirements
Women who are breastfeeding or pregnant
Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area
Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents
Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks
Acute dermatitis outbreak or dermatitis on or near the test area on the back
Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity)
Subject participation in clinical trials of investigational drugs, treatments, or devices, other than T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Fowler, MD
Organizational Affiliation
Dermatology Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Specialists PSC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
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Bioequivalence of Ethylenediamine Dihydrochloride Study
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