Evaluation of Effects of HP828-101 for Moisture Associated Skin Damage (NCT01108523) | Clinical Trial Compass
TerminatedEarly Phase 1
Evaluation of Effects of HP828-101 for Moisture Associated Skin Damage
Stopped: Business decision
United States7 participantsStarted 2010-04
Plain-language summary
This study evaluates HP828 in the management of moisture associated skin damage after 15 days of use.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* \- The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject or subject representative, and the original signed document placed in the subject's chart. If the subject is unable to read or sign the informed consent, or unable to comprehend the information provided in the consent process, a legal guardian, decision making proxy, or next of kin must provide written consent, and if possible, subject must verbally assent to receiving an experimental treatment for their wound.
* Are 18 years of age or older, of either sex and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
* Are expected to remain in the Nursing Home or long-term acute-care (LTAC) for the duration of the study (15 days).
* Have moisture associated skin damage including denuded skin or ulceration, where:
* the damage has been present for at least 2 days but less than 6 weeks
* the area of denudation (target wound) measures greater than or equal to 2 and less than or equal to 64 cm2 in total area
* the area of total damage may be greater than 64 cm2
* Are able to…
What they're measuring
1
Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15.