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Bioequivalence of Ethylenediamine Dihydrochloride Study

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: NCT01798589
Recruitment Status : Completed
First Posted : February 26, 2013
Results First Posted : May 28, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Allerderm

Brief Summary:
The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.

Condition or disease Intervention/treatment Phase
Allergic Contact Dermatitis Drug: Ethylenediamine dihydrochloride allergen patch Phase 4

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").

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Clinical Evaluation of TRUE Test Ethylenediamine Dihydrochloride Allergen: Bioequivalence of Vehicle Formulations
Study Start Date : July 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ethylenediamine dihydrochloride
Ethylenediamine dihydrochloride in methylcellulose 50 mcg/cm2 Ethylenediamine dihydrochloride in polyvinylpyrrolidone 50 mcg/cm2 Methylcellulose (negative control 1) Polyvinylpyrrolidone (negative control 2)
Drug: Ethylenediamine dihydrochloride allergen patch
1 allergen panel containing 2 allergen and 2 control patches
Other Name: T.R.U.E. Test allergen ethylenediamine dihydrochloride




Primary Outcome Measures :
  1. Number of Participants With Positive Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) [ Time Frame: 21 days ]
    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 :
  1. Number of Participants With Late Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) [ Time Frame: Day 7-21 ]
    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)

  2. Number of Participants With Persistent Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) [ Time Frame: Day 3-21 ]
    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.

  3. Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) [ Time Frame: Day 2 (48 hours after application) ]
    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.

  4. Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) [ Time Frame: Day 2 (48 hours after patch application) ]
    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.

  5. Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) [ Time Frame: Day 2 (48 hours after application) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798589


Locations
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United States, Kentucky
Dermatology Specialists PSC
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Allerderm
Investigators
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Principal Investigator: Joseph Fowler, MD Dermatology Specialists
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Responsible Party: Allerderm
ClinicalTrials.gov Identifier: NCT01798589    
Other Study ID Numbers: SPD 12 P1 401
First Posted: February 26, 2013    Key Record Dates
Results First Posted: May 28, 2020
Last Update Posted: July 2, 2020
Last Verified: May 2020
Keywords provided by Allerderm:
ethylenediamine dihydrochloride
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases