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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01222000 |
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Date of registration:
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12/10/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
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Scientific title:
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TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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8 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01222000 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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chiaverini christine, Dr |
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Address:
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Telephone:
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Email:
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chiaverini.c@chu-nice.fr |
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Affiliation:
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Name:
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Chiaverini Christine, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU de Nice - Service de dermatologie |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients of both sexes of at least 8 years and less than 65 years.
- Patients with a clinical diagnosis of LI
- Patients having at once a score of roughness and a desquamation of intensity
moderated in severe (at least 2) on every side of the body,
- Patients and\or relatives / representatives of the parental authority in measure to
understandand to follow the procedures of the study
- Consent of patient and\or parents / representatives of the parental authority
- Patient member to the Social Security
Exclusion Criteria:
- Patient of less than 8 years
- Pregnant, breast-feeding women or old enough to procreate without reliable medical
contraception,
- Women with a positive pregnancy test,
- Transaminases > twice the normal.
- Patients with congenital ichthyosis others than LI,
- Patients with a erythrodermic composent,
- Patients affected by LI of the light gravity (score < 2 for the desquamation or the
roughness) on at least a side of the body,
- Patients with secondary infection ,
- Patients with known allergy of to one of the ingredients contained in the tested
product,
- Patients with specific topical treatment (for example analogues of vitamin A, vitamin
D similar),
- Patients with topical keratolytic treatment (for example the urea, the hydroxy-acids)
in 7 days before the beginning of the clinical trial
- Patients and\or relatives / representatives of the parental authority unable to
understand and\or to follow the procedures of the study,
- Tea intake during the trail
Age minimum:
8 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lamellar Ichthyosis
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Intervention(s)
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Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
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Primary Outcome(s)
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action and the tolerance of a daily application of topical Polyphénon E 10% ®
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Relapse
[Time Frame: J84]
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global tolerance and acceptability by the patient of the Polyphénon E ® ointment
[Time Frame: J28]
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severity of the palmar and plantar involvement
[Time Frame: J28]
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level of pruritus
[Time Frame: until J28]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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