Hydrogel Blister Patch Prototype Treatment for Foot Blisters on the Heel
Study to evaluate the safety and performance of a new blister patch intended to treat blisters on the heel of the foot.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Feasibility Study to Evaluate the Safety and Performance of a Hydrogel Blister Patch Prototype for the Treatment of Foot Blisters|
- Investigator Assessment [ Time Frame: at subject's last visit, within 14 days of start ] [ Designated as safety issue: No ]Global assessment of the product by the investigator at the subject's last visit.
- Subject Assessment [ Time Frame: at subject's last visit, within 14 days of start ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Record of the time it took for the blister to heal within the 14-day study period.
|Study Start Date:||March 2010|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: Experimental Blister Patch
Experimental Hydrogel Blister patch
Device: Experimental Blister Patch
Experimental hydrogel blister patch to be applied as needed (at least every 2 days) consecutively until blister heals
Other Name: No trade name available - not a marketed product
Active Comparator: Marketed Pflaster
Scholls Blasen Pflaster
Device: Marketed Pflaster
Foot Blister Patch to be applied as needed (at least every 2 days) until blister heals
Other Name: Scholls Blasen Pflaster
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.
|Hamburg, Germany, 20354|
|Study Director:||Qing Li, PhD||J&J Consumer and Personal Products Worldwide|