NCT00825565

Study of Alwextin® Cream in Treating Epidermolysis Bullosa

Open-label, Pilot Study to Investigate the Safety and Tolerability of Alwextin 3.0% Cream in the Treatment of Epidermolysis Bullosa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Epidermolysis Bullosa

Interventions

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

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-01-21
• Last updated: 2018-02-28
• Results posted: 2013-01-01

Locations

1 site across 1 country: United States