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
Results First Received: October 9, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Skin Abnormalities
Intervention: Device: HP828-101

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
HP828-101 HP828-101 Experimental Formulation

Participant Flow:   Overall Study
    HP828-101  
STARTED     7  
COMPLETED     3  
NOT COMPLETED     4  
Protocol Violation                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HP828-101 HP828-101 Experimental Formulation

Baseline Measures
    HP828-101  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     6  
Age  
[units: years]
Mean ± Standard Deviation
  74.9  ± 15.6  
Gender  
[units: participants]
 
Female     3  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures
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1.  Primary:   Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15.   [ Time Frame: 15 Days ]

2.  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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jaime Dickerson, PhD
Organization: Smith & Nephew Biotherapeutics
phone: 817-302-3914
e-mail: jaime.dickerson@smith-nephew.com


No publications provided


Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01108523     History of Changes
Other Study ID Numbers: 828-101-09-017
Study First Received: April 20, 2010
Results First Received: October 9, 2013
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board