Efficacy and tolerance of the emollient cream V0034 CR in the symptomatic treatment of the ichthyosis in children. International, multicentric, randomised, controlled, double blind study, in parallel groups V0034 CR versus vehicle. - V00034 CR 309 1B

• Conditions: patients presenting with an ichthyosis; MedDRA version: 9.1Level: HLTClassification code 10021197Term: Ichthyoses

• Registration Number: EUCTR2006-003369-14-IT
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-12
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

- under 18 year-old male or female ambulatory patient,

- suffering from an ichthyosis, excepted bullous forms of the disease, with symmetric lesions,

- having a SRRC score  4 on both external face of the legs,

- with scaling  2 (on the SRRC score) on both external face of the legs,

- willing and able to understand and sign an approved Informed Consent Form, and/or whose parent(s) or guardian(s) has(have) given his/her(their) written consent for their child's participation in the study,

- able to understand the protocol and to attend the control visits, and/or whose parent(s) or guardian(s) is(are) cooperative with regard to compliance with study-related constraints.

- if required by national regulations, registered with a social security or health insurance system.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* Criteria related to pathologies

?Severe forms of ichthyosis requiring an hospitalisation,

?Dermatological disease other than ichthyosis liable to interfere with the assessment,

?History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.

* Criteria related to treatments

?History of allergy or intolerance to the study drug or its excipients, or to cosmetics,

?Treatment by systemic retinoids started or modified during the last 2 months,

?Homeopathic treatment during the last 2 months,

?Treatment by local retinoids, topical or systemic corticosteroids (injectable, oral), tazarotene, calcipotriol during the last month,

?Treatment by keratinolytics such as urea, propylene glycol, polyethylene glycol, salicylic acid, alphahydroxy acids, N-acetylcysteine during the last week,

?Treatment by UV-B therapy during the last week,

?Treatment by UV-A therapy.

* Criteria related to the way of life

?Use of food supplements able to modify skin (vitamin A ?) during the study duration,

?Practice of swimming pool, sauna, hammam, spa, UV during the study,

?Immoderate use of alcohol or tobacco.

* Criteria related to the population

?Parent(s) or guardian(s) linguistically or psychologically unable to understand the information given or to give his/her(their) informed consent or who refuses(refuse) to give his/her(their) consent in writing, or patient linguistically or psychologically unable to understand the information given or formulate his/her informed consent or who refuses to give his/her consent in writing,

?Parent(s) or guardian(s) subject to an administrative or court order or subject to guardianship or wardship or patient subject to an administrative or court order or subject to guardianship or wardship,

?Parent(s) or guardian(s) who cannot be contacted by telephone in an emergency, or patient who cannot be contacted by telephone in an emergency,

?Participation to another clinical trial in the previous month or during the study.

For girls:

- known pregnancy or breast feeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the efficacy of a 4 weeks treatment by the emollient V0034CR in reducing the disease severity assessed by a specified symptom sum score (SRRC) system on both legs.;Secondary Objective: To document the maintenance of the efficacy after 12 weeks of treatment<br><br>To evaluate the global judgement by the investigator<br><br>To evaluate if the product is pleasant to use by the parents and/or the patient<br><br>To document the clinical, local and systemic, safety over 12 weeks.;Primary end point(s): ?Percentage of patients having a 50% reduction of the SRRC score (Scaling, Roughness, Redness, Cracks fissures) between D1 and D28 on the external face of the legs (mean of the 2 legs).