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



Status:Recruiting
Conditions:Skin and Soft Tissue Infections, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:October 2010
Contact:Brett A King, MD, PhD
Email:brett.king@yale.edu
Phone:203-737-4825

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Palifermin Treatment of Toxic Epidermal Necrolysis

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.


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
We found this trial at
2
sites
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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Bridgeport, Connecticut 06610
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