Bioequivalence of Ethylenediamine Dihydrochloride Study

NCT ID: NCT01798589

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-08-31

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").

Conditions

Allergic Contact Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Ethylenediamine dihydrochloride

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

Group Type: EXPERIMENTAL

Ethylenediamine dihydrochloride allergen patch

Intervention Type: DRUG

1 allergen panel containing 2 allergen and 2 control patches

Interventions

Ethylenediamine dihydrochloride allergen patch

1 allergen panel containing 2 allergen and 2 control patches

Intervention Type: DRUG

Other Intervention Names

T.R.U.E. Test allergen 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allerderm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Specialists

Locations

Dermatology Specialists PSC

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

SPD 12 P1 401

Identifier Type: -

Identifier Source: org_study_id