E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients presenting with ichthyosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10040785 |
E.1.2 | Term | Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
To document the maintenance of the efficacy after 12 weeks of treatment To evaluate the global judgement by the investigator To evaluate if the product is pleasant to use by the parents and/or the patient To document the clinical, local and systemic, safety over 12 weeks. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Double blind for the first 4 weeks - Open for the end |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |