Clinical Trial: Safety, Tolerability, and Efficacy of 21 Days Dermal Application of MRX-6 on Mild to Moderate Contact Dermatitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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.
Detailed Summary:
Sponsor: Hadassah Medical Organization
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: Hadassah Medical Organization
Dates:
Date Received: March 22, 2009
Date Started: March 2011
Date Completion:
Last Updated: April 19, 2015
Last Verified: March 2012
