Phase 4
N=16
Bioequivalence of Ethylenediamine Dihydrochloride Study
Allergic Contact Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT01798589 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With Positive Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) — 10; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ethylenediamine dihydrochloride allergen patch (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allerderm
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Positive Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) |
10; 11 | — |
| SECONDARY Number of Participants With Late Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) |
1; 1 | — |
| SECONDARY Number of Participants With Persistent Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) |
7; 8 | — |
| SECONDARY Number of Participants With Tape Irritation to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) |
10; 5; 0; 0 | — |
| SECONDARY Number of Participants With Itching to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) |
6; 4; 3; 2 | — |
| SECONDARY Number of Participants With Burning to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone) |
7; 6; 1; 1 | — |
Summary
The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.
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
Data sourced from ClinicalTrials.gov (NCT01798589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.