Informations générales (source: ClinicalTrials.gov)
Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin
Interventional
Phase 3
Centre Hospitalier Universitaire de Nice (Voir sur ClinicalTrials)
juin 2011
juin 2012
29 juin 2024
Dowling Meara type of epidermolysis bullosa simplex (EBS-DM) is a rare genodermatosis due
to keratin 5 and 14 mutation, characterized by skin fragility and spontaneous or post
traumatic blisters. Neonatal period and infancy are critical since this autonomic
dominant affection usually improves with age. Cyclins seem to be efficient in some cases
of EBS but are prohibited in children younger than 8 years old. Erythromycin can be a
good alternative in this population due to its antibacterial and anti-inflammatory
potential.
The aim of this study is the evaluation of the efficiency of oral erythromycin to
decrease the number of cutaneous blisters in severe EBS-DM patients from 6 months to 8
years old after 3 months of treatment.
Primary end point is the number of patients with decrease of blisters' number of at least
20% after 3 months of treatment by oral erythromycin.
It is a preliminary study on 8 patients. Treatment is oral erythromycin twice a day
during 3 months. Follow up for each patient is 5 months. The duration of the study is 1
year.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Dijon - Dijon - France | Pierre Vabres, PU-PH | Contact (sur clinicalTrials) | |||
| Hôpital Purpan - Toulouse - France | Juliette MAZEREEUW, PU-PH | Contact (sur clinicalTrials) | |||
| Hôpital Saint Eloi - Montpellier - France | Didier Bessis, PH | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Nice - Hôpital de Cimiez - 06000 - Nice - France | Christine Chiaverini, PH | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Severe Dowling Meara EBS patients (2 or more new blisters a day)
- signature of informed consent
- Patient of 2 sexes
- Age from 6 months to 8 years. From this age we consider that the patient will less
need this treatment or can take cyclines.
- Systematic Obtaining of the consent lit(enlightened) by the relatives(parents) of
the child, after information about the objectives and the constraints of the study.
- Agreement of the minor
- Patient member to the Social Security
- Severe Dowling Meara EBS patients (2 or more new blisters a day)
- signature of informed consent
- Patient of 2 sexes
- Age from 6 months to 8 years. From this age we consider that the patient will less
need this treatment or can take cyclines.
- Systematic Obtaining of the consent lit(enlightened) by the relatives(parents) of
the child, after information about the objectives and the constraints of the study.
- Agreement of the minor
- Patient member to the Social Security
- Patient allergic to the erythromycin
- Patient presenting an intolerance to the fructose, a syndrome of malabsorption some
glucose and some galactose or a deficit sucrase-isomaltase
- Renal and\or hepatic Insufficiency
- Patient taking a medicine against indicated or misadvised in association with the
erythromycin