G-CSF in the Treatment of Toxic Epidermal Necrolysis (NeupoNET)

December 26, 2025 updated by: Anne-Françoise Rousseau, University of Liege

Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Burn Centre of the University Hospital of Liège
      • Loverval, Belgium
        • IMTR Burn Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: G-CSF
An intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4.
Drug: recombinant granulocyte - colony stimulating factor
Other Names:
  • Neupogen (Amgen)
Placebo Comparator: Placebo
An intravenous dose of 5 ml of NaCl 0.9% will be administered daily, from admission (day 0) to day 4.
Drug: NaCl 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
At admission and at day 5
Biological data: Neutrophilic count
Time Frame: Every day during the 14th first days
Neutrophilic count
Every day during the 14th first days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological data: WBC count
Time Frame: 3 months after discharge
WBC count
3 months after discharge
Biological data: WBC formula
Time Frame: 3 months after discharge
WBC formula
3 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

March 7, 2023

Study Completion (Actual)

March 7, 2023

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimated)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 26, 2025

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stevens - Johnson Syndrome

Clinical Trials on recombinant granulocyte - colony stimulating factor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe