Traitement des épidermolyses bulleuses simples de type Dowling Maera par l'érythromicine orale

Phase 1

• Conditions: Dowling Maera's bullous epidermolysis is a génodermatose with autosomique dominant transmission owed to transfers of the genes coding for keratins. It results from it a cutaneous fragility very severe especially during the early childhood. Tetracyclines showed a certain efficiency in cases isolated probably by their anti-inflammatory action but cannot be used at the young child's. The érythromycine, used in the other inflammatory dermatosis, seems to be a good candidate for these patients.; MedDRA version: 12.1Level: LLTClassification code 10056508Term: Acquired epidermolysis bullosa

• Registration Number: EUCTR2010-024428-10-FR
• Lead Sponsor: CHU de NICE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-03
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

- Patient of 2 sexes
- Carrier of a severe EBS-DM (more than 2 new bubbles a day on average)
- Age from 3 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 by the 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

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient allergic to the érythromycine
- Patient presenting an intolerance to the fructose, a syndrome of bad absorption some glucose and some galactose or a deficit it sucrase-isomaltase
- Renal and\or hepatic insufficiency
- Patient taking a medicine against indicated or disadvised in association with the erythromycin

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Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified