G-CSF in the Treatment of Toxic Epidermal Necrolysis

• Register: ClinicalTrials.gov
• Last refreshed on: 3 July 2023
• Main ID: NCT02739295
• Date of registration: 04/04/2016
• Prospective Registration: Yes
• Primary sponsor: University of Liege
• Public title: G-CSF in the Treatment of Toxic Epidermal Necrolysis NeupoNET
• Scientific title: Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis
• Date of first enrolment: July 2016
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02739295
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 4

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion Criteria:

- Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission

Exclusion Criteria:

- Toxic epidermal necrolysis with SCORTEN 6 or 7 at admission

- Hypercoagulable state

- Cardiac or peripheral arterial disease

- Active malignancy

- Myelodysplastic syndrome or hematological malignancy

- Fructose intolerance

- Pregnancy

- Patient refusal



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stevens - Johnson Syndrome

Intervention(s)

Drug: recombinant granulocyte - colony stimulating factor

Drug: NaCl 0.9%

Primary Outcome(s)

Biological data: Neutrophilic count [Time Frame: Every day during the 14th first days]

Time for healing [Time Frame: From date of randomization until the date of complete healing, assessed up to 30 days.]

Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa) [Time Frame: At admission and at day 5]

Secondary Outcome(s)

Biological data: WBC formula [Time Frame: 3 months after discharge]

Biological data: WBC count [Time Frame: 3 months after discharge]

Secondary ID(s)

L002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors