Evaluation of Effects of HP828-101 for Moisture Associated Skin Damage

Skin Abnormalities Clinical Trial

Official title:

Open Label Evaluation of the Effects of HP828-101 in the Management of Moisture Associated Skin Damage in Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01108523
• Other study ID #: 828-101-09-017
• Status: Terminated
• Phase: Phase 0
• First received: April 20, 2010
• Last updated: October 9, 2013
• Start date: April 2010
• Est. completion date: February 2012

Study information

• Verified date: October 2013
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study evaluates HP828 in the management of moisture associated skin damage after 15 days of use.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: February 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Abnormalities

Intervention

Device:
• HP828-101

Locations

Country	Name	City	State
United States	Golden Acres	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15.		15 Days	No
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		4, 8, 12, and 15 days	No