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Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin

Information source: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epidermolysis Bullosa

Intervention: Oral erythromycin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Centre Hospitalier Universitaire de Nice

Official(s) and/or principal investigator(s):
Christine Chiaverini, PH, Principal Investigator, Affiliation: CHU de NIce

Summary

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.

Clinical Details

Official title: Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: number of patients with decrease of blisters' number of at least 20% after 3 months of treatment by oral erythromycin

Secondary outcome:

Secondary end points are : effect of 3 months of oral erythromycin on - Global tolerance of treatment.

Secondary end points are : effect of 3 months of oral erythromycin on - Involved area

Secondary end points are : effect of 3 months of oral erythromycin on - pruritus,

Eligibility

Minimum age: 6 Months. Maximum age: 8 Years. Gender(s): Both.

Criteria:

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

Exclusion Criteria:

- 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

Locations and Contacts

CHU de Dijon, Dijon, France; Recruiting
Pierre Vabres, PU-PH, Email: pierre.vabres@chu-dijon.fr

Hôpital Saint Eloi, Montpellier, France; Not yet recruiting
Didier Bessis, PH

CHU de Nice - Hôpital de Cimiez, Nice 06000, France; Recruiting
Christine Chiaverini, PH, Phone: 0033 4 92 03 61 07, Email: chiaverini.c@chu-nice.fr
Vanina Oliveri, ARC, Phone: 0033 4 92 03 42 54, Email: oliveri.v@chu-nice.fr

Hôpital Purpan, Toulouse, France; Recruiting
Juliette MAZEREEUW, PU-PH, Phone: 00 33 5 67 77 81 41, Email: mazereeuw-hautier.j@chu-toulouse.fr

Additional Information

Starting date: June 2011
Last updated: October 13, 2011

Page last updated: August 23, 2015

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