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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
Children's Memorial Hospital |
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00825565 |
Purpose
The purpose of this study is to determine how safe and effective Alwextin cream is in improving the healing of recurrent skin lesions and reducing overall blistering in people with epidermolysis bullosa compared to placebo. Alwextin cream contains an active ingredient, whereas the placebo is the vehicle only. Both Alwextin and placebo are supplied in the form of a cream, and applied topically, meaning it is gently applied directly to all affected areas on the skin. Alwextin cream or placebo cream is also called "study medicine" in this consent form.
| Condition | Intervention | Phase |
|---|---|---|
|
Epidermolysis Bullosa |
Drug: Alwextin cream and placebo cream |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Placebo-Controlled Pilot Study to Investigate the Effects of Alwextin Cream in the Treatment of Epidermolysis Bullosa |
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Alwextin cream
|
Drug: Alwextin cream and placebo cream
Alwextin cream contains active ingredient and placebo cream does not.
|
|
2: Placebo Comparator
placebo cream
|
Drug: Alwextin cream and placebo cream
Alwextin cream contains active ingredient and placebo cream does not.
|
To participate in the study, subjects will come to the clinic for a screening visit. If they qualify, they will need to return to the clinic for 3 additional visits (4 visits total). Study medicine will be applied once a day to the entire body. One lesion (the index lesion) will be measured at each visit as determined by the study doctor. The study staff will perform a skin exam, and photographs will be taken. Study duration is 12 weeks. Subject medication diaries will be completed during the study. Subjects will be assigned to receive either the study cream or the placebo cream at random on a 1:1 basis (50% chance of receiving active, 50% chance of receiving vehicle).
Eligibility| Ages Eligible for Study: | 6 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Marcy Urbanich | 312-695-6829 | m-urbanich@northwestern.edu |
| Contact: Candrice Heath, MD | 773-327-3326 | cheath@childrensmemorial.org |
| United States, Illinois | |
| Children's Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Reena M Vaid, MD 773-327-3326 rvaid@childrensmemorial.org | |
| Principal Investigator: Amy S. Paller, MD | |
| Sub-Investigator: Reena M Vaid, MD | |
| Principal Investigator: | Amy S Paller, MD | Northwestern University |
More Information
| Responsible Party: | Northwestern University ( Amy S. Paller, M.D., Professor and Chair of Department of Dermatology ) |
| Study ID Numbers: | Alwextin Protocol-1 |
| Study First Received: | January 19, 2009 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00825565 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Epidermolysis bullosa |
|
Skin Diseases, Vesiculobullous Skin Diseases Genetic Diseases, Inborn Skin Abnormalities |
Epidermolysis Bullosa Congenital Abnormalities Skin Diseases, Genetic |
