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

Phase 1

• Conditions: Patients presenting with ichthyosis; MedDRA version: 14.1Level: PTClassification code 10021198Term: IchthyosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2006-003369-14-ES
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-11-01
• Study Start: 2012-03-29
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 265

Inclusion Criteria

Patient presenting with the following criteria may be included:
- 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 sup. or equal to 4 on both external face of the legs,
- with scaling sup. or equal to 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: 270
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

Patients presenting with any of the following criteria will not be included:

* 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