Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous

• ClinicalTrials.gov Identifier: NCT01222000
• Recruitment Status: Unknown
• First Posted: October 18, 2010
• Last Update Posted: October 18, 2010
• Sponsor: Centre Hospitalier Universitaire de Nice
• Information provided by: Centre Hospitalier Universitaire de Nice

Tracking Information

• First Submitted Date: October 12, 2010
• First Posted Date: October 18, 2010
• Last Update Posted Date: October 18, 2010
• Study Start Date: October 2010
• Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 15, 2010)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 15, 2010)

• severity of the palmar and plantar involvement [ Time Frame: J28 ]
• level of pruritus [ Time Frame: until J28 ]
• global tolerance and acceptability by the patient of the Polyphénon E ® ointment [ Time Frame: J28 ]
• Relapse [ Time Frame: J84 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
• Official Title: TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS

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 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 %

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lamellar Ichthyosis

Intervention

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.

Study Arms

• Experimental: right controlled against moisturizing cream
  Intervention: Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
• Experimental: left controlled against moisturizing cream
  Intervention: Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 15, 2010): 8
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2011
• Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01222000
• Other Study ID Numbers: 09-PP-02
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Centre Hospitalier Universitaire de Nice
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Universitaire de Nice
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Chiaverini Christine, Dr; CHU de Nice - Service de dermatologie

• PRS Account: Centre Hospitalier Universitaire de Nice
• Verification Date: October 2010