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

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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
Enrollment 1
Recruitment Details Subjects were recruited from US hospital-based clinics. Recruitment was from December 2007 to December 2008.
Pre-assignment Details 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.
Arm/Group Title Apligraf
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 1 [1]
Completed 0 [2]
Not Completed 1
Reason Not Completed
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Subject withdrawn from study at Day 7.
Arm/Group Title Apligraf/Control
Hide Arm/Group Description Apligraf (a living bilayered cell therapy product) Control (a primary nonadherent dressing, nonstick gauze, retainer dressing)
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
1
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Proportion of Wounds First Achieving 100% Epithelialization of Tissue With the Absence of Drainage (i.e. Complete Wound Closure) Through Study Week 12
Hide Description [Not Specified]
Time Frame Through 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
no analysis performed as only 1 subject enrolled
Arm/Group Title Apligraf Control
Hide Arm/Group Description:
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.
Within subject control: 2 lesions per subject randomized to receive Apligraf or Control treatment. Control treated lesion receives standard wound dressings.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Time Until Complete Closure
Hide Description [Not Specified]
Time Frame through 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
no analysis performed as only 1 subject enrolled
Arm/Group Title Apligraf Control
Hide Arm/Group Description:
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.
Within subject control: 2 lesions per subject randomized to receive Apligraf or Control treatment. Control treated lesions receive standard wound dressings.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Rate of Complete Wound Closure Over Time
Hide Description [Not Specified]
Time Frame through 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
no analysis performed as only 1 subject enrolled
Arm/Group Title Apligraf Control
Hide Arm/Group Description:
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.
Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Recurrence of Epidermolysis Bullosa (EB) Lesions
Hide Description [Not Specified]
Time Frame through 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
no analysis performed as only 1 subject enrolled
Arm/Group Title Apligraf Control
Hide Arm/Group Description:
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.
Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Reduction of Intensity of Pain
Hide Description [Not Specified]
Time Frame through 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
no analysis performed as only 1 subject enrolled
Arm/Group Title Apligraf Control
Hide Arm/Group Description:
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.
Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Proportion of Wounds Experiencing an Adverse Event
Hide Description [Not Specified]
Time Frame through 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was only 1 enrolled subject in the study; this endpoint was descriptively reported, no statistical analyses were performed.
Arm/Group Title Apligraf Control
Hide Arm/Group Description:
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.
Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame December 2007 through August 2008
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Apligraf
Hide Arm/Group Description 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.
All-Cause Mortality
Apligraf
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Apligraf
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Apligraf
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
General disorders   
Fever   1/1 (100.00%)  1
Infections and infestations   
Wound Infection (signs and symptoms)  [1]  1/1 (100.00%)  2
Indicates events were collected by systematic assessment
[1]
Two events reported, both treated lesions were simulataneously reported as having a wound infection.
Study terminated early, the 1 enrolled subject subsequently discontinued study at Day 7.
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.
Before publishing PI shall submit copies of any proposed publication/presentation to Sponsor for review at least 30 days in advance of submission. Sponsor shall review the data provided in proposed publication against the Study database for consistency. Sponsor reserves right to delete any Confidential Information/proprietary information of Sponsor from the proposed publication/presentation. Sponsor may extend such review period for another 90 days.
Results Point of Contact
Name/Title: Director of Clinical Operations
Organization: Organogenesis Inc.
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