Clinical Trial: Hydrogel Blister Patch Prototype Treatment for Foot Blisters on the Heel

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Feasibility Study to Evaluate the Safety and Performance of a Hydrogel Blister Patch Prototype for the Treatment of Foot Blisters

Brief Summary: Study to evaluate the safety and performance of a new blister patch intended to treat blisters on the heel of the foot.

Detailed Summary: The study will require participation for up to 14 days of participation or less if the blister heals sooner, will recruit 100 subjects with fluid filled blisters on the heel of the foot that are intact and not broken. Some subjects will be asked to have their blisters photographed. All subjects will be required to have their blister unroofed (top layer of skin removed by the physician using sterile instruments). All subjects will receive study product, either test product or a marketed product.
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Current Primary Outcome: Investigator Assessment [ Time Frame: at subject's last visit, within 14 days of start ]

Global assessment of the product by the investigator at the subject's last visit.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Subject Assessment [ Time Frame: at subject's last visit, within 14 days of start ]
    Global assessment of the product by the subject at the subject's last visit.
  • Time to Heal [ Time Frame: Baseline to subject's last visit, within 14 days of start ]
    Record of the time it took for the blister to heal within the 14-day study period.


Original Secondary Outcome: Same as current

Information By: Johnson & Johnson Consumer and Personal Products Worldwide

Dates:
Date Received: March 16, 2010
Date Started: March 2010
Date Completion:
Last Updated: October 4, 2011
Last Verified: October 2011