Study of Alwextin® Cream in Treating Epidermolysis Bullosa

This study has been completed.
Sponsor:
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Amy Paller, Northwestern University
ClinicalTrials.gov Identifier:
NCT00825565
First received: January 19, 2009
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Epidermolysis Bullosa
Drug: Alwextin cream
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Pilot Study to Investigate the Safety and Tolerability of Alwextin 3.0% Cream in the Treatment of Epidermolysis Bullosa

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    A common measure of the degree of involvement in skin disease is the Body Surface Area Index (BSAI). This measure is also commonly used in psoriasis studies. It is a global measure of disease "spread" with weighting factors.

  • Target Wound Size Reduction or Closure [ Time Frame: baseline and then every 4 weeks for a total of 12 weeks ] [ Designated as safety issue: No ]

    EB patients may have chronic wounds which are resistant to healing. Wound size may be very large and the probability of total wound closure with currently available treatments is unlikely. Reduction in the size of wounds may be clinically important to the rate of infection and pain. If a patient has a reduction in the size of wounds which are refractory to healing, this may be seen as a positive outcome. Wound size reduction is one of the primary assessments used to determine the efficacy of the study cream.

    Wounds which had been present for at least several weeks prior to study entry were measured by using VISITRAK Digital, a Smith and Nephew wound tracing and measurement system that will calculate the length and width of the lesion (class 1 medical device; FDA listing designation E142354FDA). Only one target lesion per patient was used for the study assessment. At each subsequent study until the final visit, the target lesion was evaluated using VISITRAK Digital.


  • Physician Global Assessment of Severity (PGAS) [ Time Frame: baseline and then every 4 weeks for a total of 12 weeks ] [ Designated as safety issue: No ]

    The FDA has suggested that a global measure of severity might be the best way to assess EB from visit to visit. Assessment score may be influenced by other clinical observations in addition to the percentage of body affected by blistering and erosions. The assessment was intended to be a "global impression."

    This scale produced a score with the following correlations:

    0 = clear (no blistering/erosions) 1-2 = almost clear (infrequent blistering and erosions) 3-4 = mild disease (up to 15% of body affected) 5-6 = moderate disease (between 16-25% of body affected) 7-8 = severe disease (between 26-50% of body affected) 9-10 = very severe disease (greater than 50% of body affected)


  • Physician Assessment of Individual Signs [ Time Frame: baseline and then every 4 weeks for a total of 12 weeks ] [ Designated as safety issue: No ]

    In addition to skin blistering and erosions, people with EB experience other symptoms, such as erythema on unblistered skin, wound oozing, weeping, and crusting. These symptoms may vary with area of the body evaluated.

    This scale evaluates the following signs: Blistering and erosions, oozing/weeping/crusting, pruritis, erythema on unblistered surrounding skin, pain, milia Each of these signs will be scored in 4 body areas: head/neck, upper limbs, trunk, lower limbs The following scale is used:0 = clear 1 = almost clear 2 = mild 3 = moderate 4 = severe



Enrollment: 8
Study Start Date: February 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alwextin cream
8 subjects enrolled in this single study arm. All 8 subjects completed the study.
Drug: Alwextin cream
Alwextin cream contains active ingredient, allantoin 3%. Use 1 application daily for 3 month duration.
Other Names:
  • Alwextin
  • Alwyn
  • allantoin

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.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • history of epidermolysis bullosa

Exclusion Criteria:

  • use of any skin product containing allantoin for 30 days prior to enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825565

Locations
United States, Illinois
Robert and Ann Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Amy S Paller, MD Northwestern University
  More Information

No publications provided

Responsible Party: Amy Paller, Professor and Chair of Deparment of Dermatology, Professor of Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT00825565     History of Changes
Other Study ID Numbers: Alwextin 3.0%-04
Study First Received: January 19, 2009
Results First Received: February 22, 2012
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
Epidermolysis bullosa

Additional relevant MeSH terms:
Epidermolysis Bullosa
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous

ClinicalTrials.gov processed this record on September 16, 2014