Bioequivalence of Ethylenediamine Dihydrochloride Study

Allerderm Laboratories

Status and phase: Completed; Phase 4

Conditions: Allergic Contact Dermatitis

Treatments: Drug: Ethylenediamine dihydrochloride allergen patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01798589

SPD 12 P1 401

Details and patient eligibility

About

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

Full 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").

Enrollment: 16 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Ethylenediamine dihydrochloride

Experimental group

Description:

Ethylenediamine dihydrochloride in methylcellulose 50 mcg/cm2 Ethylenediamine dihydrochloride in polyvinylpyrrolidone 50 mcg/cm2 Methylcellulose (negative control 1) Polyvinylpyrrolidone (negative control 2)

Treatment:

Drug: Ethylenediamine dihydrochloride allergen patch