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Study of Alwextin® Cream in Treating Epidermolysis Bullosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00825565
Recruitment Status : Completed
First Posted : January 21, 2009
Results First Posted : January 1, 2013
Last Update Posted : February 28, 2018
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Amy Paller, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Epidermolysis Bullosa Drug: Alwextin cream Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    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.

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

    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.

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

    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)

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

    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • history of epidermolysis bullosa

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00825565

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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
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Principal Investigator: Amy S Paller, MD Northwestern University
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Responsible Party: Amy Paller, Professor and Chair of Deparment of Dermatology, Professor of Pediatrics, Northwestern University Identifier: NCT00825565    
Other Study ID Numbers: Alwextin 3.0%-04
First Posted: January 21, 2009    Key Record Dates
Results First Posted: January 1, 2013
Last Update Posted: February 28, 2018
Last Verified: January 2018
Keywords provided by Amy Paller, Northwestern University:
Epidermolysis bullosa
Additional relevant MeSH terms:
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Epidermolysis Bullosa
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
Dermatologic Agents