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

NCT ID: NCT00867607

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-03-31

Brief Summary

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.

Conditions

Allergic Contact Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MRX-6 (2%)

Group Type: EXPERIMENTAL

MRX-6

Intervention Type: DRUG

b.i.d treatment for 21 days

MRX-6 (1%)

Group Type: EXPERIMENTAL

MRX-6

Intervention Type: DRUG

b.i.d treatment for 21 days

MRX-6 (0.2%)

Group Type: EXPERIMENTAL

MRX-6

Intervention Type: DRUG

b.i.d treatment for 21 days

Steroid

Group Type: ACTIVE_COMPARATOR

Steroid

Intervention Type: DRUG

b.i.d. 21 days

Interventions

MRX-6

b.i.d treatment for 21 days

Intervention Type: DRUG

Steroid

b.i.d. 21 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Morria Biopharmaceuticals PLC

INDUSTRY

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuval Ramot, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah university hospital, Jerusalem Israel

Locations

dermatology department, Hadassah university hospital

Jerusalem, Israel, Israel

Department of Dermatology, Hadassah Hospital

Ein Karem, Jerusalem, , Israel

Countries

Israel

References

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.

Reference Type: RESULT

PMID: 17346444 (View on PubMed)

Other Identifiers

MRX6-201ver4-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id