EUCTR2009-013656-77-FR
Active, not recruiting
Not Applicable
Traitment of recessive nonbullous congenital ichthyosis with topic Epigallocatechin.
ice University Hospital0 sites0 target enrollmentAugust 6, 2009
ConditionsRecessive nonbullous congenital ichthyosisMedDRA version: 12.0Level: HLTClassification code 10021197Term: Ichthyoses
DrugsVEREGEN(R)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Recessive nonbullous congenital ichthyosis
- Sponsor
- ice University Hospital
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Both male and female patients over 8 years of age and under 64 years of age,
- •\- Patients with diagnostic of lamellar ichthyosis,
- •\- Patients with roughness and desquamation skin scores with moderate or severe intensity (equal or over 2 on each side of the body),
- •\- Patients and/or parents /representatives of the parental authority able to understand and follow the proceedings of the study,
- •\- Patients and/or parents /representatives of the parental authority willing to sign the proper consent forms,
- •\- Patients covered by Social Security .
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •\- Patients under 8 years of age,
- •\- Pregnant or breastfeeding women (a qualitative urine pregnancy test will be given to all women of child\-bearing age),
- •\- Patients with a transaminase rate over twice the normal,
- •\- Patients with congenital ichthyosis other than lamellar ichthyosis,
- •\- Patients with an erythrodermic constituent,
- •\- Patients with light roughness and desquamation skin scores (under 2 on one side of the body at least ),
- •\- Patients with secondary infection caused by a lesion
- •\- Patients with an allergy in one of the component of the trial product
- •\- Patients treated with specific topics (vitamin A and D analogous for example),
- •\- Patients treated with keratolytic (urea for example) in the 7 day before the beginning of the clinical trial,
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
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