Recessive nonbullous congenital ichthyosis MedDRA version: 12.0 Level: HLT Classification code 10021197 Term: Ichthyoses
Conditions
Interventions
Trade Name: VEREGEN(R)
Product Name: VEREGEN(R)
Pharmaceutical Form: Ointment
Sponsors
Nice University Hospital
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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, - Patients and/or parents /representatives of the parental authority incapable of understanding (foreign language, intellectual deficiencies, motor cortex deficiencies...) and/or following the proceedings, - Withdrawal of patient consent - Persons already participating in another clinical trial or in the 3 monthes before the beginning of the trial. - Drinkers of tea during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of this trial is the evaluation of the topic Polyphenon E(R) efficacity in order to ameliorate the skin desquamation and the skin roughness in lamellar ichthysosis patients after 4 weeks of traitment.;Secondary Objective: The secondary objectives are the evaluation of - the remission time obtain after each traitment - the severity of the affected hands and feet - the perception by patient and/or his family of globar tolerance of the topic Polyphenon E(R).;Primary end point(s): The evaluation of the primary end points will be realized in blind by an investigator. It is about the rate of answering patients, leaning on the improvement of the clinical symptomatology. | — |
Countries
France
Outcome results
None listed