ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)

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.
ClinicalTrials.gov Identifier: NCT00587223
Recruitment Status : Terminated (Insufficient patient enrollment)
First Posted : January 7, 2008
Results First Posted : June 22, 2010
Last Update Posted : June 29, 2010
Sponsor:
Information provided by:
Organogenesis

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Epidermolysis Bullosa, Junctional
Epidermolysis Bullosa Dystrophica
Interventions: Device: Apligraf
Other: Standard dressing regimen

  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 recruited from US hospital-based clinics. Recruitment was from December 2007 to December 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A screening period of 1 week was utilized in the study design prior to randomization of study lesions to Apligraf or control at Day 0.

Reporting Groups
  Description
Apligraf Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.

Participant Flow:   Overall Study
    Apligraf
STARTED   1 [1] 
COMPLETED   0 [2] 
NOT COMPLETED   1 
Adverse Event                1 
[1] Study design was within-subject control. Only 1 subject was enrolled in the study.
[2] Subject withdrawn from study at Day 7.



  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
Apligraf/Control Apligraf (a living bilayered cell therapy product) Control (a primary nonadherent dressing, nonstick gauze, retainer dressing)

Baseline Measures
   Apligraf/Control 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
 
<=18 years   1 
Between 18 and 65 years   0 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   0 
Male   1 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   1 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   1 


  Outcome Measures

1.  Primary:   Proportion of Wounds First Achieving 100% Epithelialization of Tissue With the Absence of Drainage (i.e. Complete Wound Closure) Through Study Week 12   [ Time Frame: Through 12 weeks ]

2.  Secondary:   Time Until Complete Closure   [ Time Frame: through 12 weeks ]

3.  Secondary:   Rate of Complete Wound Closure Over Time   [ Time Frame: through 12 weeks ]

4.  Secondary:   Recurrence of Epidermolysis Bullosa (EB) Lesions   [ Time Frame: through 12 months ]

5.  Secondary:   Reduction of Intensity of Pain   [ Time Frame: through 12 weeks ]

6.  Secondary:   Proportion of Wounds Experiencing an Adverse Event   [ Time Frame: through 12 months ]


  Serious Adverse Events


  Other Adverse Events


  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
Study terminated early, the 1 enrolled subject subsequently discontinued study at Day 7.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Director of Clinical Operations
Organization: Organogenesis Inc.
e-mail: kgiovino@organo.com



Responsible Party: Katherine B. Giovino, Director of Clinical Operations, Organogenesis Inc.
ClinicalTrials.gov Identifier: NCT00587223     History of Changes
Other Study ID Numbers: 06-EB-001-AG
First Submitted: December 21, 2007
First Posted: January 7, 2008
Results First Submitted: March 29, 2010
Results First Posted: June 22, 2010
Last Update Posted: June 29, 2010