Safety, Tolerability, and Efficacy of 21 Days Dermal Application of MRX-6 on Mild to Moderate Contact Dermatitis

A Double-blind, Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of Three Weeks of Daily Dermal Application of MRX-6 (2% HyPE) on the Treatment of Mild to Moderate Contact Dermatitis of the Hand and Forearm

A Double-blind, Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of Three Weeks of Daily Dermal Application of MRX-6 or steroid on the Treatment of Mild to Moderate Allergic Contact Dermatitis of the Hand and Forearm.

Total number of patients: up to 80.

Study Overview

• Status: Completed
• Conditions: Allergic Contact Dermatitis
• Intervention / Treatment: Drug: MRX-6; Drug: Steroid

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Ein Karem, Jerusalem, Israel
    • Department of Dermatology, Hadassah Hospital
  • Jerusalem, Israel
    • dermatology department, Hadassah university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adult men and women between 18 and 65 years old.
2. Male or non-pregnant female subjects who agree to comply with applicable contraceptive requirements of the protocol. Details on potential child-bearing status, methods to regularly exclude pregnancy throughout the study and acceptable forms of contraception are provided in Section 3.4.1 of the protocol.
3. Satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, clinical or laboratory evaluation [hematology, biochemistry, urinalysis]) as determined by the Principal Investigator, that might interfere with the assessment of the subjects dermatitis or the assessment of the safety or efficacy of the Study Drug.
4. The subject must understand and be able, willing and likely to fully comply with study procedures and restrictions.
5. Subject can understand and provide written informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures listed in Section 5.1.1 of the protocol.
6. Subject has mild to moderate bilateral allergic contact dermatitis on each hand, possibly extending to the forearm, according to Physicians Visual Assessment as described in Section 5.2.1 of the protocol. Mild to moderate disease is considered a PVA score of 10 or greater and there should be no more than a 1-point difference between hands.
7. Have a + reaction to the Standard European Series patch testing kit (Chemotechnique Diagnostics Products, Malmo, Sweden) after application for 2 days, as described in Section 5.2.2 of the protocol.

Exclusion Criteria:

1. Current or recurrent disease that could affect the action, absorption or disposition of the Study Drug, or clinical or laboratory assessments.
2. Have used topical antihistamines in the past 2 weeks, topical corticosteroids or received Psoralen plus ultra violet light therapy (PUVA) in the past 4 weeks, or have taken oral retinoids, corticosteroids in the past 8 weeks (inhaled or intranasal corticosteroids are allowed, if stable dose).
3. Use of any prescription or OTC medication (excluding hormonal contraceptive, hormonal replacement therapy, inhaled or intranasal corticosteroids , or oral NSAIDs) that, in the opinion of the Principal Investigator, could affect (improve or worsen) the condition being studied, or could affect the action, absorption or disposition of the Study Drug, or clinical or laboratory assessments.
4. Patients must not have used another investigational product or taken part in a clinical trial within the last 30 days prior to enrolment.
5. Female patients who are pregnant or lactating, including females with a positive pregnancy test at screening, must be excluded.
6. The subject known to have a positive hepatitis virus test (Hepatitis B virus surface antigen or hepatitis C virus antibody) or a positive human immunodeficiency virus (HIV) antibody test.
7. A history of hypersensitivity to any of the Study Drugs or their excipients.
8. Subject has any other significant dermatological condition that affects >10% of the body surface area or general medical condition that could interfere with the study evaluation
9. Subject has any significant medical condition that could compromise immune responsiveness
10. Subject has a history of alcoholism or drug abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Steroid	Drug: Steroid; b.i.d. 21 days
Experimental: MRX-6 (2%)	Drug: MRX-6; b.i.d treatment for 21 days
Experimental: MRX-6 (1%)	Drug: MRX-6; b.i.d treatment for 21 days
Experimental: MRX-6 (0.2%)	Drug: MRX-6; b.i.d treatment for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The safety and tolerability of three dose levels of topical MRX-6 (0.2%, 1.0% and 2% HyPE) when administered twice daily (b.i.d.) for 21 consecutive days	Day 21

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in percentage change in each subject's total Physician's Visual Assessment (PVA) score from Baseline to Day 21 between the vehicle and MRX-6 treated hands/forearms.	Day 21

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Collaborators: Morria Biopharmaceuticals PLC
• Investigators: Principal Investigator: Yuval Ramot, MD, Hadassah university hospital, Jerusalem Israel

Publications and helpful links

General Publications

• Ingber A, Cohen Y, Krimsky M, Yedgar S. A novel treatment of contact dermatitis by topical application of phospholipase A2 inhibitor: a double-blind placebo-controlled pilot study. Int J Immunopathol Pharmacol. 2007 Jan-Mar;20(1):191-5. doi: 10.1177/039463200702000123.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: March 22, 2009
• First Submitted That Met QC Criteria: March 22, 2009
• First Posted (Estimate): March 24, 2009

Study Record Updates

• Last Update Posted (Estimate): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 19, 2015
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Eczema; Contact dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
• Other Study ID Numbers: MRX6-201ver4-HMO-CTIL