Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis
Conditions
Brief 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.
Interventions
DRUGPalifermin
Sponsors
Swedish Orphan Biovitrum
Brett King
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Palifermin Palifermin 60 micrograms/kg/day IV for 3 consecutive days | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Palifermin |
|---|---|
| Age, Customized Age | 73 years |
| Sex/Gender, Customized Male | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 1 / 1 |
Outcome results
Primary
Time-to-cutaneous Re-epithelialization
Time frame: The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palifermin | Time-to-cutaneous Re-epithelialization | 6 days |
Secondary
Time-to-cessation of Epidermal Necrosis
Time frame: The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palifermin | Time-to-cessation of Epidermal Necrosis | 3 days |
Secondary
Time-to-mucosal Re-epithelialization
Time frame: The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days
Population: Adverse event experienced by participant precluded measuring this outcome.