Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous

Plain-language summary

This Phase 3 study evaluates VEREGEN 10% cream, made from green tea extract, compared with a moisturizing cream in patients with lamellar ichthyosis, an inherited skin disease; each patient received the drug on one side of the body and the moisturizer on the other. It included ichthyosis patients aged 8-65 with moderate-to-severe scaling and roughness. It was carried out in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Centre Hospitalier Universitaire de Nice

Intervention

apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side, apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side

Start date

10/1/2010

Estimated completion

3/25/2013

Countries

France

Related genes

Locations

• Nice, France
• Toulouse, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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