Lamellar IchthyosisPhase 3NCT01222000
Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
A Phase 3 study testing apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side in people with Lamellar Ichthyosis, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Lamellar Ichthyosis
- What is being tested?
- apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2010to 25 Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de dermatologie CHU de Nice
Nice
Toulouse University Hospital, Dermatology Department
Toulouse
About this study
Official title: 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.
Read more
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 %
- Conditions
- Lamellar Ichthyosis
- Being tested
- apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
- Medical subject headings
- Ichthyosis, Lamellar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other sideDrug
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.
apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other sideDrug
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 group | Role | What they receive |
|---|---|---|
| right controlled against moisturizing cream | Experimental | Not described Receives: Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side |
| left controlled against moisturizing cream | Experimental | Not described Receives: Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side |
What is being measured
The primary outcome is the main question the study is designed to answer.
action and the tolerance of a daily application of topical Polyphénon E 10% ®
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.
Measured: 4 weeks
Secondary outcomes (4)
severity of the palmar and plantar involvement
Measured: J28
level of pruritus
Measured: until J28
global tolerance and acceptability by the patient of the Polyphénon E ® ointment
Measured: J28
Relapse
Measured: J84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startOct 2010
- Primary completion25 Mar 2012
- Study completion25 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lamellar IchthyosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiaverini Christine, Dr, Principal investigator, CHU de Nice - Service de dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222000
- Sponsor's protocol ID
- 09-PP-02
- Status last verified
- Jun 2026
- First submitted
- 12 Oct 2010
- Last updated
- 17 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS
- ClinicalTrials.gov ID
- NCT01222000
- Acronym / sponsor ID
- 09-PP-02
- Conditions
- Lamellar Ichthyosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- 25 Mar 2012 (actual)
- Study completion
- 25 Mar 2013 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 %
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| right controlled against moisturizing cream | Experimental | Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side |
| left controlled against moisturizing cream | Experimental | Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other sideAfter 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. | Drug | right controlled against moisturizing cream |
| apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other sideAfter 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. | Drug | left controlled against moisturizing cream |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
Related trials for Lamellar Ichthyosis
Not yet recruitingObservational study
Lymphocyte Phenotype of Autosomal Recessive Congenital Ichthyoses Mutated NIPAL4 (Nipal4-nEDD)
Sezary Syndrome, Ichthyosis, Lamellar
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiaverini Christine, Dr principal investigator
CHU de Nice - Service de dermatologie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side in people with Lamellar Ichthyosis, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
action and the tolerance of a daily application of topical Polyphénon E 10% ® (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.