We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Healing Effects of HP802-247 Versus Antibiotic Ointment in Mohs Micrographic Surgery Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01359735
First Posted: May 25, 2011
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Healthpoint
Results First Submitted: September 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-melanoma Skin Cancer
Interventions: Biological: HP802-247
Biological: Bacitracin Ointment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at a single US investigational site, between June 22, 2011and November 16, 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who met inclusion criteria returned for visit1 on the day of surgery and entered the study following. Subjects randomly assigned to HP802-247 or Bacitracin for post-surgical treatment, which lasted for up to 12 weeks or wound closure, which ever occurred first. Following completion of treatment subjects were followed for 4 weeks

Reporting Groups
  Description
HP802-247

allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly

HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed

Bacitracin Ointment

bacitracin antibiotic ointment

Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).


Participant Flow:   Overall Study
    HP802-247   Bacitracin Ointment
STARTED   4   4 
COMPLETED   4   4 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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
HP802-247

allogeneic, growth arrested keratinocytes and fibroblasts: final concentration of 5.0 M cells/mL with a ratio of 1:9 keratinocytes:fibroblasts, applied weekly

HP802-247: High dose HP 802-247, applied at each visit (Week 1-13) or until healed

Bacitracin Ointment

bacitracin antibiotic ointment

Bacitracin Ointment: One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).

Total Total of all reporting groups

Baseline Measures
   HP802-247   Bacitracin Ointment   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   4   8 
Age 
[Units: Years]
Mean (Standard Deviation)
 74  (11.6)   66.8  (10.7)   70.4  (11) 
Age, Customized 
[Units: Participants]
     
50-69 yrs   2   2   4 
70+ yrs   2   2   4 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  25.0%      0   0.0%      1  12.5% 
Male      3  75.0%      4 100.0%      7  87.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      4 100.0%      4 100.0%      8 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      4 100.0%      4 100.0%      8 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Primary Efficacy Measure Was the Investigator’s Global Assessment of Healing (IGAH).   [ Time Frame: 13 weeks- The IGAH was measured at study Weeks 4 and 13 ]

2.  Secondary:   The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.   [ Time Frame: Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks ]

3.  Secondary:   Time in Days to Wound Closure   [ Time Frame: Over the 12 week treatment period ]

4.  Secondary:   Investigator Reported Signs and Symptoms   [ Time Frame: At each evaluation visit: Weeks 3 and 12 post-surgery. ]

5.  Secondary:   Subject Reported Signs and Symptoms   [ Time Frame: At each evaluation visit: Weeks 3, and 12 post-surgery. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 E Dickerson, PhD
Organization: Smith & Nephew
phone: 1-817-302-3914
e-mail: Jaime.Dickerson@smith-nephew.com



Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01359735     History of Changes
Other Study ID Numbers: 802-247-09-022
First Submitted: May 23, 2011
First Posted: May 25, 2011
Results First Submitted: September 13, 2016
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017