Overview

Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis

Status:
Terminated
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
To test the ability of palifermin (a recombinant human keratinocyte growth factor) to decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis Overlap, diseases in which there is extensive sloughing of the skin and mucosa, including that of the eyes, gastrointestinal tract, respiratory and genitourinary systems.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Brett King
Collaborator:
Swedish Orphan Biovitrum
Criteria
Inclusion Criteria:

- Skin biopsy in early disease showing apoptotic keratinocytes in the epidermis and in
more advanced disease necrosis of the entire epidermis

- Epidermal detachment or erythematous to purpuric macules involving more than 10% of
body surface area in addition to involvement of the oropharynx; there may be further
involvement of other mucosal surfaces, ie. conjunctivae, gastrointestinal tract,
respiratory and genitourinary epithelia

- Age of 18 years old or older

- The patient is expected to survive longer than 48 hours

Exclusion Criteria:

- Skin detachment above 90% of the body surface area

- Skin detachment has not progressed during the previous 48 hours

- A positive serum pregnancy test

- Age < 18 years old

- Known hematologic or solid organ malignancy