Skin Abnormalities
Conditions
Keywords
Moisture Associated Skin Damage
Brief summary
This study evaluates HP828 in the management of moisture associated skin damage after 15 days of use.
Interventions
DEVICEHP828-101
Sponsors
Healthpoint
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 verbally respond to the Pre- and Post- Treatment Survey. * Women of child-bearing potential may participate in the study if they have a negative urine pregnancy test and use adequate birth control, as determined by the Investigator. * Are capable of maintaining adequate nutritional intake during the study
Exclusion criteria
* Have more than 64 cm2 of denuded area. * Have a full-thickness target wound, or a full-thickness wound within 4 cm of any target wound area. * Have clinical evidence of bacterial or fungal infection of the target wound area. * Have, within the area of moisture damaged skin, any tunneling, sinus tracks, shear injury, arterial occlusive disease, or bony prominence or joint with the exception that target wounds may be over dorsal spinous processes, coccyx, ischial tuberosities, or sacroiliac joints. * Are moribund, or have a severe burn, debilitating immunodeficiency disorder, significant hematologic disorder, metastatic malignancy, uncontrolled diabetes mellitus, or any medical conditions that, in the opinion of the Investigator, places the subject at risk for the study or incapable of healing. * Are known to have acrodermatitis enteropathica (zinc deficiency). * Are being treated currently with systemic steroids, immunosuppressive agents, radiation, or chemotherapy. * Have been treated with enzymatic debridement to the target wound area within 2 days prior to enrollment. * Have a known sensitivity to ingredients of HP828-101. * Are using or have used another investigational agent (not including devices such as hearing aids, pace makers, etc.) within 30 days prior to Visit 1. * The Medical Monitor may declare any subject ineligible for a valid medical reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15. | 15 Days |
Secondary
| Measure | Time frame |
|---|---|
| Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 4, 8, and 12. Proportion of Subjects With no Denuded Skin Area at Day 4, 8, 12, and 15. Pre- and Post-Treatment Surveys | 4, 8, 12, and 15 days |
Countries
United States
Participant flow
Recruitment details
Male or female subjects, age ≥ 18 years old, who were receiving care in a Nursing Home or Long Term Acute Care Facility (LTAC) and who had qualifying moisture damaged skin, with denudation in the range of 2 to 64 cm x cm
Participants by arm
| Arm | Count |
|---|---|
| HP828-101 HP828-101 Experimental Formulation | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 4 |
Baseline characteristics
| Characteristic | HP828-101 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age Continuous | 74.9 years STANDARD_DEVIATION 15.6 |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 1 / 7 |
Outcome results
Primary
Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15.
Time frame: 15 Days
Secondary
Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 4, 8, and 12. Proportion of Subjects With no Denuded Skin Area at Day 4, 8, 12, and 15. Pre- and Post-Treatment Surveys
Time frame: 4, 8, 12, and 15 days