Clinical Trial: G-CSF in the Treatment of Toxic Epidermal Necrolysis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis

Brief Summary:

NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis. This is a prospective randomized controlled trial.

Patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at admission and will be followed until 3 months after discharge.

Detailed Summary:
Sponsor: University Hospital of Liege

Current Primary Outcome:

• Time for healing [ Time Frame: From date of randomization until the date of complete healing, assessed up to 30 days. ]
  Time for complete cutaneous healing, considered as healing of 90% of the body surface area
• Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa) [ Time Frame: At admission and at day 5 ]
  Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
• Biological data: Neutrophilic count [ Time Frame: Every day during the 14th first days ]
  Neutrophilic count

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: University Hospital of Liege

Dates:
Date Received: April 4, 2016
Date Started: July 2016
Date Completion: July 2021
Last Updated: October 28, 2016
Last Verified: October 2016