E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
xerosis in children with atopic dermatitis |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
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 V0034CR01B cream on xerosis in children with atopic dermatitis. |
|
E.2.2 | Secondary objectives of the trial |
To document the impact of the absence and the reintroduction of emollient treatment.
To document the clinical (local and systemic) safety of the treatment over the study duration.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age between 2 and 6 years included,
- Presenting with atopic dermatitis according to the diagnostic criteria of the UK Working Party,
- With xerosis on the body and a xerosis score > 2 (SCORAD sub-score) on the anterior part of lower limbs,
- Whose objective SCORAD score is < 15 at inclusion,
- Associated signs such as hyperlinearity in the palms and/or scales on the lower limbs,
- Whose parent(s) or guardian(s) has given his/her (their) written consent for their child's
participation in the study,
- Whose parent(s) or guardian(s) is (are) cooperative with regard to compliance with study-related constraints,
- Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation).
|
|
E.4 | Principal exclusion criteria |
Criteria related to pathologies
- Acute phase of atopic dermatitis with moderate/severe erythema, mild/moderate/sever excoriation, crust, oozing or exudation,
- Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,
- Primary bacterial, viral, fungal or parasitic skin infection,
- Ulcerated lesions, acne or rosacea,
- Dermatological disease other than atopic dermatitis which could interfere with the assessment,
- History of hypersensitivity or intolerance to one of the components of the tested or associated products, or to cosmetics,
- Immunosuppression,
- History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.
Criteria related to treatments
- Use of oral corticosteroids or immunosuppressants during the last 14 days,
- Use of topical corticosteroids, systemic or local antibiotics on the lesions during the last 7 days,
- Use of non-steroid anti-inflammatory drugs or antihistamines during the last 7 days,
- Regular use of food supplements that could, in the opinion of the investigator, modify skin properties (e.g. synbiotics).
Criteria related to the population
- Child with a brother or sister already included in this study,
- Patient and/or parent(s) or guardian(s) linguistically or psychologically unable to understand the information given or give his/her(their) informed consent or who refuses(refuse) to give his/her(their) consent in writing,
- Parent(s) or guardian(s) 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,
- Participation to another clinical trial or being in the exclusion period of another clinical trial. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Xerosis score: mean evolution over the different time-points of double-blind period D1–D28 (D7, D14, D21 and D28). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Double-blind period:
- Xerosis score: evolution at the different time-points of double-blind period D1–D28 (D7, D14, D21 and D28).
- Xerosis VAS: evolution at D14 and D28.
- Xerosis measured by the corneometer: Hydration Index (HI) evolution at D14 and D28.
- Evolution of Objective SCORAD at D28.
- Number of responders to treatment (patients who decrease the grade in xerosis score and whose objective SCORAD is lower than their objective SCORAD at baseline) and non responders to treatment at D28.
Exploratory criteria
- Number of days of application of the moderately potent corticosteroid.
Open-label period:
- In patients treated with V0034CR01B: the evolution of xerosis score, xerosis VAS, HI, objective SCORAD and the number of responders to treatment (patients who decrease the grade in xerosis score and those objective SCORAD is lower then objective SCORAD at baseline) at D56 and D84.
- In non treated follow-up patients: the evolution of xerosis score, xerosis VAS, HI, objective SCORAD and the number of failures at D56 and D84.
Global evaluations:
- Overall assessment of treatment efficacy by the investigator on a 4 point scale at the end double-blind period D28 and at the end of open-label period at D84 (only for patients treated with V0034CR01B).
- Overall assessment of treatment efficacy by the parents on a 4 point scale at the end double-blind period D28 and at the end of open-label period at D84 (only for patients treated with V0034CR01B).
- Overall assessment of treatment use by the parents on a 4 point scale at the end double-blind period D28 and at the end of open-label period at D84 (only for patients treated with V0034CR01B).
Safety evaluations:
- Assessment of the local tolerability (examination of the skin) and the systemic safety (general clinical examination and reported adverse events). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
D7, D14, D21, D28 (double-blind)
D56, D84 (open-label) |
|
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 | No |
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 | No |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 38 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
The end of study is the date of the last visit of the last patient undergoing the trial. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |