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

Stopped early · Phase 1/Phase 2

Conditions studied: Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome

In brief

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.

Key facts

Study ID

NCT02037347

Run by

Brett King

People needed

1

Starts

2010-10-01

Expected to finish

2014-12-01

Last updated by the study team

2016-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Yale-New Haven Hospital — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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