Study of Alwextin® Cream in Treating Epidermolysis Bullosa

Brief Title

Study of Alwextin® Cream in Treating Epidermolysis Bullosa

Official Title

Open-label, Pilot Study to Investigate the Safety and Tolerability of Alwextin 3.0% Cream in the Treatment of Epidermolysis Bullosa

Brief Summary

      The purpose of this study is to determine how safe and effective allantoin 3% cream
      (Alwextin) is in improving the healing of recurrent skin lesions and reducing overall
      blistering in people with epidermolysis bullosa (EB). Allantoin 3% cream is applied topically
      to the entire body once daily.
    

Detailed Description

      Potential subjects came to the for a screening visit. Eligible subjects had baseline
      assessments performed and were provided study medication, allantoin 3% cream. Subjects were
      instructed to apply the study medication to the entire body once daily and to keep daily
      record of study medication use. Subjects returned every 4 weeks for a total of 12 weeks for
      repeat assessments.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage

Condition

Epidermolysis Bullosa

Intervention

Alwextin cream

Study Arms / Comparison Groups

 Alwextin cream

Description:  8 subjects enrolled in this single study arm. All 8 subjects completed the study.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

8

Start Date

February 2009

Completion Date

November 2010

Primary Completion Date

November 2010

Eligibility Criteria

        Inclusion Criteria:

          -  history of epidermolysis bullosa

        Exclusion Criteria:

          -  use of any skin product containing allantoin for 30 days prior to enrollment
      

Gender

All

Ages

6 Months - N/A

Accepts Healthy Volunteers

No

Contacts

Amy S Paller, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00825565

Organization ID

Alwextin 3.0%-04

Responsible Party

Principal Investigator

Study Sponsor

Northwestern University

Collaborators

 Ann & Robert H Lurie Children's Hospital of Chicago

Study Sponsor

Amy S Paller, MD, Principal Investigator, Northwestern University

Verification Date

January 2018