Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01222000
First received: October 12, 2010
Last updated: October 15, 2010
Last verified: October 2010
  Purpose

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 %

Condition Intervention Phase
Lamellar Ichthyosis
Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • action and the tolerance of a daily application of topical Polyphénon E 10% ® [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • severity of the palmar and plantar involvement [ Time Frame: J28 ] [ Designated as safety issue: No ]
  • level of pruritus [ Time Frame: until J28 ] [ Designated as safety issue: No ]
  • global tolerance and acceptability by the patient of the Polyphénon E ® ointment [ Time Frame: J28 ] [ Designated as safety issue: No ]
  • Relapse [ Time Frame: J84 ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: October 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: right controlled against moisturizing cream Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
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.
Experimental: left controlled against moisturizing cream Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
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.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222000

Contacts
Contact: chiaverini christine, Dr chiaverini.c@chu-nice.fr

Locations
France
Toulouse University Hospital, Dermatology Department
Toulouse, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Chiaverini Christine, Dr CHU de Nice - Service de dermatologie
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01222000     History of Changes
Other Study ID Numbers: 09-PP-02
Study First Received: October 12, 2010
Last Updated: October 15, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Infant, Newborn, Diseases
Ichthyosis
Ichthyosis, Lamellar
Congenital Abnormalities
Genetic Diseases, Inborn
Ichthyosiform Erythroderma, Congenital
Keratosis
Skin Abnormalities
Skin Diseases
Skin Diseases, Genetic
Emollients
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014