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Study to evaluate the safety and performance of a new blister patch intended to treat blisters on the heel of the foot.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Blister Patch | Experimental | Experimental Hydrogel Blister patch |
|
| Marketed Pflaster | Active Comparator | Scholls Blasen Pflaster |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Blister Patch | Device | Experimental hydrogel blister patch to be applied as needed (at least every 2 days) consecutively until blister heals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessment | Global assessment of the product by the investigator at the subject's last visit. | at subject's last visit, within 14 days of start |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Assessment | Global assessment of the product by the subject at the subject's last visit. | at subject's last visit, within 14 days of start |
| Time to Heal | Record of the time it took for the blister to heal within the 14-day study period. |
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Inclusion Criteria:
Male or female subjects, 18 years of age or older;
Individuals who are willing and able to provide informed consent
Female subjects of child bearing potential must have a negative urine pregnancy test prior to application of the study products;
Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 such as the ones listed below and agree to continue using this method during their participation in the study; Note that abstinence is not an approved method of birth control.
Individuals exhibit a blister on the heel that is determined by the investigator to be no more than 72 hours old and in stage 2
Subject is willing to have blister unroofed (top layer of blister removed) by the investigator
Subject is willing and able to follow the study directions, to participate in the study, and to return for all specified visits
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing Li, PhD | J&J Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCIderm GmbH | Hamburg | 20354 | Germany |
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| ID | Term |
|---|---|
| D001768 | Blister |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
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|
| Marketed Pflaster | Device | Foot Blister Patch to be applied as needed (at least every 2 days) until blister heals |
|
|
| Baseline to subject's last visit, within 14 days of start |
| D013568 | Pathological Conditions, Signs and Symptoms |