Status:
UNKNOWN
Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Lamellar Ichthyosis
Eligibility:
All Genders
8+ years
Phase:
PHASE3
Brief Summary
Lamellar ichthyosis (IL) is a rare autosomal recessive genodermatosis with a defect of keratinization of the skin which results in a severe generalized cutaneous xerosis with dark brown big scales, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01222000
Start Date
October 1 2010
End Date
June 1 2011
Last Update
October 18 2010
Active Locations (1)
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1
Toulouse University Hospital, Dermatology Department
Toulouse, France