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Study of Alwextin® Cream in Treating Epidermolysis Bullosa

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ClinicalTrials.gov Identifier: NCT00825565
Recruitment Status : Completed
First Posted : January 21, 2009
Results First Posted : January 1, 2013
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Epidermolysis Bullosa
Intervention: Drug: Alwextin cream

  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 identified at regularly scheduled clinic visits with the Principal Investigator at Children's Memorial Hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were instructed to discontinue use of allantoin 1.5% cream (Alwyn) for at least 30 days prior to initiating the study medication, allantoin 3% cream (Alwextin).

Reporting Groups
  Description
Allantoin 3% Cream This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.

Participant Flow:   Overall Study
    Allantoin 3% Cream
STARTED   8 
COMPLETED   8 
NOT COMPLETED   0 



  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
Allantoin 3% Cream This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.

Baseline Measures
   Allantoin 3% Cream 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      8 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 3.3  (2.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  62.5% 
Male      3  37.5% 
Region of Enrollment 
[Units: Participants]
 
United States   8 


  Outcome Measures

1.  Primary:   Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage   [ Time Frame: baseline and then every 4 weeks for a total of 12 weeks ]

2.  Primary:   Target Wound Size Reduction or Closure   [ Time Frame: baseline and then every 4 weeks for a total of 12 weeks ]

3.  Primary:   Physician Global Assessment of Severity (PGAS)   [ Time Frame: baseline and then every 4 weeks for a total of 12 weeks ]

4.  Primary:   Physician Assessment of Individual Signs   [ Time Frame: baseline and at 12 weeks ]


  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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stephanie Rangel
Organization: Northwestern University
phone: 312-503-5942
e-mail: stephanie.rangel@northwestern.edu



Responsible Party: Amy Paller, Northwestern University
ClinicalTrials.gov Identifier: NCT00825565     History of Changes
Other Study ID Numbers: Alwextin 3.0%-04
First Submitted: January 19, 2009
First Posted: January 21, 2009
Results First Submitted: February 22, 2012
Results First Posted: January 1, 2013
Last Update Posted: February 28, 2018