Study of Alwextin® Cream in Treating Epidermolysis Bullosa

NCT ID: NCT00825565

Last Updated: 2018-02-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-11-30

Brief Summary

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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

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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.

Conditions

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Epidermolysis Bullosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alwextin cream

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

Group Type EXPERIMENTAL

Alwextin cream

Intervention Type DRUG

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

Interventions

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Alwextin cream

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

Intervention Type DRUG

Other Intervention Names

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Alwextin Alwyn allantoin

Eligibility Criteria

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Inclusion Criteria

* history of epidermolysis bullosa

Exclusion Criteria

* use of any skin product containing allantoin for 30 days prior to enrollment
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Amy Paller

Professor and Chair of Deparment of Dermatology, Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy S Paller, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Robert and Ann Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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Alwextin 3.0%-04

Identifier Type: -

Identifier Source: org_study_id

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