Trial record 3 of 20 for:    Open Studies | "Dermatitis, Contact"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Morria Biopharmaceuticals PLC
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00867607
First received: March 22, 2009
Last updated: March 25, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Allergic Contact Dermatitis
Drug: MRX-6
Drug: Steroid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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 [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Steroid Drug: Steroid
b.i.d. 21 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867607

Contacts
Contact: Yuval Ramot, MD +97226777111 yramot@gmail.com

Locations
Israel
Department of Dermatology, Hadassah Hospital Recruiting
Ein Karem, Jerusalem, Israel
Contact: Yuval Ramot, MD    +97226777111    yramot@gmail.com   
Principal Investigator: Yuval Ramot, MD         
dermatology department, Hadassah university hospital Recruiting
Jerusalem, Israel
Contact: Yuval Ramot, MD    97226777111    yramot@gmail.com   
Sponsors and Collaborators
Hadassah Medical Organization
Morria Biopharmaceuticals PLC
Investigators
Principal Investigator: Yuval Ramot, MD Hadassah university hospital, Jerusalem Israel
  More Information

Additional Information:
Publications:
Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00867607     History of Changes
Other Study ID Numbers: MRX6-201ver4-HMO-CTIL
Study First Received: March 22, 2009
Last Updated: March 25, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Contact dermatitis
Eczema

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014