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NCT Number: NCT01222000

Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous

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 ectropion, an eclabion, an alopecia and a palmo-plantar keratodermia. They are due to mutations of the gene TGM1 coding for the transglutaminase keratinocyte 1 (TG1) in 1/3 of the cases. Other genes were recently identified, ABCA12 coding for the triphosphate-binding adenosine cassette A12 and FLJ39501 which codes for a protein of the cytochrome p450 ( CYP4F2).

No etiological treatment is available. Symptomatic treatment consists on twice application of emollients and keratolytic ointments which decrease the dryness of the skin and reduce scales. Oral isotretinoin is usually partially effective but is only suspensive and has numerous side effects.

Recent studies showed that the epigallocatechin-3-gallate (POLYPHENON E®), extracted from green tea increases the differentiation of the normal human keratinocytes, as showedb by the increase of the involucrine, TG1 and caspase-14 genes expression.

The main objective of this pilot study is to estimate the action and the tolerance of a daily application of topical Polyphénon E 10% ® to improve the desquamation and the cutaneous roughness of patients with lamellar ichthyosis, after 4 weeks of treatment.

The secondary objectives

* To estimate the duration of remission obtained after the treatment * To estimate the action of cutaneous Veregen® to improve the palmar and plantar involvement. * To estimate the action of cutaneous Veregen on the pruritus * And to estimate the global level of acceptability by the patient of the Veregen 10 %

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Key information

Conditions

Lamellar Ichthyosis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Ichthyosiform Erythroderma, Congenital Ichthyosis Ichthyosis, Lamellar Infant, Newborn, Diseases Keratosis Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service de dermatologie CHU de Nice, Nice, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

After inclusion, the localization of test area will be decided and the side to treat with VEREGEN 10% will be randomized. Patient will be seen every week for 4 weeks for clinical evaluation of assessment criteria by an independent assessor. According to the randomisation he will apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side. If there is an improvement of at least a test zone he will enter in the follow-up period for 8 weeks.

Primary outcomes

  1. action and the tolerance of a daily application of topical Polyphénon E 10% ®

    Time frame: 4 weeks

    The main objective of this pilot study is to estimate the action and the tolerance of a daily application of topical Polyphénon E 10% ® to improve the desquamation and the cutaneous roughness of patients with lamellar ichthyosis, after 4 weeks of treatment.

Secondary outcomes

  1. severity of the palmar and plantar involvement

    Time frame: J28

  2. level of pruritus

    Time frame: until J28

  3. global tolerance and acceptability by the patient of the Polyphénon E ® ointment

    Time frame: J28

  4. Relapse

    Time frame: J84

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Oct 18, 2010
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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