Stevens-Johnson Syndrome Clinical Trial
Official title:
Palifermin Treatment of Toxic Epidermal Necrolysis
Verified date | August 2016 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Bridgeport Hospital | Bridgeport | Connecticut |
United States | Yale-New Haven Hospital | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Brett King | Swedish Orphan Biovitrum |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time-to-cutaneous re-epithelialization | The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days | No | |
Secondary | Time-to-mucosal re-epithelialization | The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days | No | |
Secondary | Time-to-cessation of epidermal necrosis | The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days | No |
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