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

This study has been terminated.
(Business decision)
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01108523
First received: April 20, 2010
Last updated: October 9, 2013
Last verified: October 2013

April 20, 2010
October 9, 2013
April 2010
July 2010   (final data collection date for primary outcome measure)
Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15. [ Time Frame: 15 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01108523 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Evaluation of Effects of HP828-101 for Moisture Associated Skin Damage
Open Label Evaluation of the Effects of HP828-101 in the Management of Moisture Associated Skin Damage in Adults

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

Not Provided
Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Skin Abnormalities
Device: HP828-101
Experimental: HP828-101
HP828-101 Experimental Formulation
Intervention: Device: HP828-101
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
February 2012
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01108523
828-101-09-017
No
Healthpoint
Healthpoint
Not Provided
Study Chair: Herbert B Slade, MD Healthpoint
Principal Investigator: Neeta Nayak, MD Golden Acres
Healthpoint
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP