Clinical trial NCT01798589: Bioequivalence of Ethylenediamine Dihydrochloride Study
Official title: Clinical Evaluation of TRUE Test Ethylenediamine Dihydrochloride Allergen: Bioequivalence of Vehicle Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Contact Dermatitis
Keywords: ethylenediamine dihydrochloride
Lead sponsor: Allerderm
Sponsor class: INDUSTRY
First posted: 2013-02-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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").

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

Primary outcomes:
measure: Number of Participants With Positive Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
timeFrame: 21 days
Secondary outcomes:
measure: Number of Participants With Late Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
timeFrame: Day 7-21
measure: Number of Participants With Persistent Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
timeFrame: Day 3-21
measure: Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
timeFrame: Day 2 (48 hours after application)
measure: Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
timeFrame: Day 2 (48 hours after patch application)
measure: Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)
timeFrame: Day 2 (48 hours after application)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Dermatology Specialists PSC
state: Kentucky
Study officials:
affiliation: Dermatology Specialists
name: Joseph Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References: