|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01340235 |
|
Date of registration:
|
11/04/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin
|
|
Scientific title:
|
Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin |
|
Date of first enrolment:
|
June 2011 |
|
Target sample size:
|
8 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01340235 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Christine Chiaverini, PH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHU de NIce |
| | |
|
Key inclusion & exclusion 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
Age minimum:
6 Months
Age maximum:
8 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Epidermolysis Bullosa
|
|
Intervention(s)
|
|
Drug: Oral erythromycin
|
|
Primary Outcome(s)
|
|
number of patients with decrease of blisters' number of at least 20% after 3 months of treatment by oral erythromycin
[Time Frame: at 3 months of treatment]
|
|
Secondary Outcome(s)
|
|
Secondary end points are : effect of 3 months of oral erythromycin on - Global tolerance of treatment.
[Time Frame: at 3 months of treatment]
|
|
Secondary end points are : effect of 3 months of oral erythromycin on - Involved area
[Time Frame: at 3 months of treatment]
|
|
Secondary end points are : effect of 3 months of oral erythromycin on - pruritus,
[Time Frame: at 3 months of treatment]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|