Clinical Trial: A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: An Exploratory, Cross-Over Study of the Safety of HP802-247 Applied to Open Wounds of Subjects With Dystrophic Epidermolysis Bullosa

Brief Summary: This is a pilot study designed to see if HP802-247, an investigational treatment with living human skin cells, helps to heal blisters or wounds in subjects with Dystrophic Epidermolysis Bullosa (DEB). The durability of the skin in healed wounds treated with HP802-247 will also be assessed.

Detailed Summary:
Sponsor: Healthpoint

Current Primary Outcome: Time to healing [ Time Frame: 4 weeks ]

Time to healing, defined as the number of days between wound onset (caregiver reported) and complete epithelialization (Investigator assessed).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Wound pain as measured by faces pain scale [ Time Frame: 4 weeks for each of 3 treatment periods ]
    Change from baseline (i.e., Week 1 of each period) in wound pain for each visit (Weeks 2-5 of each treatment period)as assessed by the Faces Pain Scale (FPS)
  • Percent of change in wound area [ Time Frame: 4 weeks for each of 3 treatment periods ]
    Percent of change from baseline (i.e., Week 1 of each period) in the target wound area for each visit and Weeks 2-5 of each treatment period.
  • Persistence of healing [ Time Frame: 4 weeks for each of 3 treatment periods ]
    Persistence of healing as assessed by lack of blister/wound recurrence for healed wounds of each period (up to 40 weeks following enrollment)
  • Burning and stinging upon application [ Time Frame: 4 weeks for each of 3 treatment periods ]

    Burning and stinging upon application of HP802-247 or its Vehicle will be assessed at each visit of each period with the exception of the end of treatment visit (Weeks 1-4 of treatment period).

    Burning/stinging scale is a four point scale (i.e., none, mild, moderate, severe).



Original Secondary Outcome: Same as current

Information By: Healthpoint

Dates:
Date Received: January 31, 2012
Date Started: March 2012
Date Completion: July 2013
Last Updated: May 15, 2012
Last Verified: May 2012