Condition category
Not Applicable
Date applied
24/01/2008
Date assigned
14/02/2008
Last edited
14/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Caroline Miklaszewski

ORCID ID

Contact details

4 Rue Marie Curie
BP22132
Ramonville St Agne
31521
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R00002 CR 2 01 (ORF)

Study information

Scientific title

Acronym

Study hypothesis

The short term efficacy and safety of the tazarotene cream at two different dosages need to be assessed and compared in (lamellar ichthyosis) LI patients, using an intra-individual design (left/right comparison of tazarotene 0.1% versus tazarotene 0.05% versus vehicle), as a pre-requisite of the phase III pivotal study.

As of 14/08/2009, this record has been updated to include an extended anticipated end date; the initial anticipated end date was 31/12/2008.

Ethics approval

France:
1. Ethics committee for protection of biomedical research subjects (Comite de Protection des Personnes), Ile de France II (for all four centres), approved on 11 December 2007

Germany:
Approval obtained from the following ethics committees on 22 November 2007:
1. Ethics committee of the Ludwig-Maximilians University (LMU) Munich, Faculty of Medicine
2. Ethics committee of the Hamburg Clinic
3. Ethics committee of the Westfalen-Lippe Clinic and the Faculty of Medicine, University of Münster (WWU Münster)
4. Ethics Committee of the Georg-August University Goettingen, Faculty of Medicine
5. Berlin State Health and Social Ethics Committee (Landesamt Für Gesundheit Und Soziales, Geschäftsstelle Der Ethik-Kommission Des Landes Berlin)
6. Ethics Committee of the Heinreich-Heine University Düsseldorf, Faculty of Medicine

Study design

Period I (4 weeks): Randomised double-blind vehicle-controlled right/left comparison
Period II (8 weeks): Double-blind comparative treatment-free follow-up

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Non Erythrodermic Autosomic Recessive Lamellar Ichthyosis (NEARLI)

Intervention

Study treatments:
Tazarotene cream 0.1% or 0.05% and vehicle.

Dose:
Period I (4 weeks): Patients will apply one of the two active test products and the vehicle on the lesions (except on face, scalp, neck and genital areas), on two randomly allocated sides (left side and right side of the body) once daily for 4 weeks (e.g., every evening). This will be associated with the daily application of a standard moisturiser (e.g., in the morning; including face and neck). An adjusted dosage to local tolerance of test products will be performed (no test product application on irritated areas on days when they are observed).

Period II (8 weeks): No application of the test products for 8 weeks; application of the standard moisturiser only.

Mode of administration:
Topical

Intervention type

Drug

Phase

Not Specified

Drug names

Tazarotene

Primary outcome measures

Assessment of scaling and roughness by the investigator at each of the 10 visits (at screening, baseline, then on days 7, 14, 21, 28 [end of treatment, Period I], 42, 56, 70 and 84 [end of treatment-free follow-up, Period II]).

Secondary outcome measures

1. Assessment of the relapse/rebound by the investigator during Period II
2. Time-course severity of each sign (scaling and roughness) during Periods I and II
3. Separate assessment of the overall clinical severity of the lesions on palms and soles for each test side of the body at baseline and end of Period I
4. Assessment of the severity of scaling at baseline and end of Period I
5. Instrumental assessment of scaling on the two forearms using the D-squame technique, at baseline and end of Period I
6. Global local tolerance at end of Period I
7. Overall acceptability by the patients at end of Period I
8. Routine blood laboratory tests (hematology, chemistry) at baseline and at end of Period I
9. Plasma monitoring of tazarotenic acid at baseline and at end of Period I
10. Compliance
11. Physical examination
12. Adverse events

Overall trial start date

01/09/2007

Overall trial end date

20/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients of both sexes of at least 8 years of age
2. Patients with a documented diagnosis of LI based on clinical signs and, if possible, pedigree analysis
3. Patients with both scaling and roughness of moderate to severe intensity on each side of the body
4. Patients or patient's parents/guardians able to understand and follow the study procedures
5. Written informed consent from the patients or parents/guardians
6. Patients or patients' parents/guardians affiliated to a healthcare security system

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Added 14/08/2009: 30 participants (initial target: 32)

Participant exclusion criteria

1. Patients under 8 years of age
2. Pregnant women, lactating mothers or women of childbearing potential with no reliable medical contraception (combined oral contraceptive, intra-uterine contraceptive device) and unwilling to use condoms, up to 8 weeks after the last test product application
3. Women of childbearing potential with a positive systemic pregnancy test at baseline
4. Patients with congenital ichthyoses other than LI
5. Patients with an erythrodermic component of LI (EARLI)
6. Patients with LI of mild severity on at least one side of the body
7. Patients with lesional superinfection
8. Patients with skin or systemic disease likely to interfere with the study or the evaluation parameters
9. Patients with a known contact allergy to one of the ingredients contained in the test products
10. Patients with sunburn, or excessive pruritus, burning, skin redness or peeling, not fully recovered
11. Patients treated with topicals (e.g., vitamin A analogues, vitamin D analogues) within 14 days prior to baseline
12. Patients treated with keratolytics (e.g., urea, hydroxy-acids) or moisturizers other than the standard moisturizer within 7 days prior to baseline
13. Patients treated with concomitant dermatological medications and cosmetics that have a strong drying effect within 7 days prior to baseline
14. Patients treated with oral retinoids during the preceding 28 days, or with oral vitamin A supplementation (more than 3000 IU per day) during the preceding 7 days of baseline
15. Patients treated with drugs known to be photosensitizers (e.g., thiazides, tetracyclines, quinolones, phenothiazines, sulfonamides, hydrochlorates, chlorpromazine, psoralen, amiodarone, tar) within 2 weeks prior to baseline
16. Patients treated with UV therapy or patients medically exposed to UV within 4 weeks prior to baseline
17. Patients having significant sun exposure due to their occupation
18. Patients with inherent sensitivity to sunlight
19. Patients who participated in a study within the 3 months prior to study entry
20. Patients living with a family member who is currently under test treatment, i.e. Period I of the study (from baseline to day 28)
21. Patients or patients' parents/guardians who are unable to understand and/or to follow the study procedures and patient instructions
22. Patients or patients' parents/guardians who are unwilling to give written informed consent

Recruitment start date

01/09/2007

Recruitment end date

20/04/2009

Locations

Countries of recruitment

France, Germany

Trial participating centre

4 Rue Marie Curie
Ramonville St Agne
31521
France

Sponsor information

Organisation

Orfagen (France)

Sponsor details

4 Rue Marie Curie BP22132
Ramonville St Agne
31521
France

Sponsor type

Industry

Website

http://www.orfagen.com

Funders

Funder type

Industry

Funder name

Orfagen (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes