Clinical Trial: Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).
Brief Summary: Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.
Detailed Summary:
Sponsor: Fundacion IMIM
Current Primary Outcome: Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate. [ Time Frame: 5 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Erythema intensity by colorimetry. [ Time Frame: 5 days ]
- Eczema intensity by planimetric morphology (ICDRG scale) [ Time Frame: 5 days ]
- VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT) [ Time Frame: 5 days ]
Original Secondary Outcome: Same as current
Information By: Fundacion IMIM
Dates:
Date Received: February 6, 2012
Date Started: February 2012
Date Completion:
Last Updated: May 11, 2016
Last Verified: May 2016