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 ]

Time to Itch Relief is defined as the time needed to reach a 30% decrease of the maximum VAS (Visual Analogue Scale used for self-assessment of itch by the volunteers) recorded after the start of treatment.


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