Study of Alwextin® Cream in Treating Epidermolysis Bullosa

Northwestern University

Status and phase: Completed; Phase 2

Conditions: Epidermolysis Bullosa

Treatments: Drug: Alwextin cream

Study type: Interventional

Funder types: Other

Identifiers

NCT00825565

Alwextin 3.0%-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• history of epidermolysis bullosa

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

Alwextin cream

Experimental group

Description:

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

Treatment:

Drug: Alwextin cream