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 |
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.
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
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