Study of Alwextin® Cream in Treating Epidermolysis Bullosa

NCT00825565 | Completed Phase 2 Results DMC

• 1 other identifier: Alwextin 3.0%-04
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidermolysis Bullosa

Keywords

Epidermolysis bullosa

Outcome Measures

Primary Outcomes (4)

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

  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.

  baseline and then every 4 weeks for a total of 12 weeks

• Target Wound Size Reduction or Closure

  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.

  baseline and then every 4 weeks for a total of 12 weeks

• Physician Global Assessment of Severity (PGAS)

  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)

  baseline and then every 4 weeks for a total of 12 weeks

• Physician Assessment of Individual Signs

  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

  baseline and at 12 weeks

Study Arms (1)

Alwextin cream

EXPERIMENTAL

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

Drug: Alwextin cream

Interventions

Alwextin cream DRUG

Alwextin cream contains active ingredient, allantoin 3%. Use 1 application daily for 3 month duration.

Also known as: Alwextin, Alwyn, allantoin

Alwextin cream

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• history of epidermolysis bullosa

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (1)

Robert and Ann Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Epidermolysis Bullosa

Interventions

Allantoin

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Stephanie Rangel
• Organization: Northwestern University

stephanie.rangel@northwestern.edu

312-503-5942

Study Officials

• Amy S Paller, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Deparment of Dermatology, Professor of Pediatrics

Study Record Dates

• First Submitted: January 19, 2009
• First Posted: January 21, 2009
• Study Start: February 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 28, 2018
• Results First Posted: January 1, 2013

Record last verified: 2018-01

Locations

US (1)