NCT00867607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2011

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 21, 2015

Status Verified

March 1, 2012

Enrollment Period

2.1 years

First QC Date

March 22, 2009

Last Update Submit

April 19, 2015

Conditions

Allergic Contact Dermatitis

Keywords

Contact dermatitisEczema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (4)

MRX-6 (2%)

EXPERIMENTAL
Drug: MRX-6

MRX-6 (1%)

EXPERIMENTAL
Drug: MRX-6

MRX-6 (0.2%)

EXPERIMENTAL
Drug: MRX-6

Steroid

ACTIVE COMPARATOR
Drug: Steroid

Interventions

MRX-6DRUG

b.i.d treatment for 21 days

MRX-6 (0.2%)MRX-6 (1%)MRX-6 (2%)
SteroidDRUG

b.i.d. 21 days

Steroid

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult men and women between 18 and 65 years old.
  • 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.
  • 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.
  • The subject must understand and be able, willing and likely to fully comply with study procedures and restrictions.
  • 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.
  • 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.
  • 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.

You may not qualify if:

  • Current or recurrent disease that could affect the action, absorption or disposition of the Study Drug, or clinical or laboratory assessments.
  • 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).
  • 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.
  • Patients must not have used another investigational product or taken part in a clinical trial within the last 30 days prior to enrolment.
  • Female patients who are pregnant or lactating, including females with a positive pregnancy test at screening, must be excluded.
  • 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.
  • A history of hypersensitivity to any of the Study Drugs or their excipients.
  • 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
  • Subject has any significant medical condition that could compromise immune responsiveness
  • Subject has a history of alcoholism or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

dermatology department, Hadassah university hospital

Jerusalem, Israel, Israel

Location

Department of Dermatology, Hadassah Hospital

Ein Karem, Jerusalem, Israel

Location

Related Publications (1)

  • 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.

    PMID: 17346444RESULT

MeSH Terms

Conditions

Dermatitis, Allergic ContactDermatitis, ContactEczema

Interventions

Steroids

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yuval Ramot, MD

    Hadassah university hospital, Jerusalem Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2009

First Posted

March 24, 2009

Study Start

March 1, 2011

Primary Completion

April 1, 2013

Study Completion

March 1, 2014

Last Updated

April 21, 2015

Record last verified: 2012-03

Locations

IL(2)