xerosis in children with atopic dermatitis MedDRA version: 14.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: DEXERYL, cream
Product Name: DEXERYL
Product Code: V0034CR01B
Pharmaceutical Form: Cream
INN or Proposed INN: GLYCEROL
CAS Number: 56-81-5
Other descriptive name: GLYCEROL
Concentration un
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of V0034CR01B cream on xerosis in children with atopic dermatitis.;Secondary Objective: 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. ;Primary end point(s): Xerosis score: mean evolution over the different time-points of double-blind period D1–D28 (D7, D14, D21 and D28). ;Timepoint(s) of evaluation of this end point: D7, D14, D21 and D28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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).;Timepoint(s) of evaluation of this end point: D7, D14, D21, D28 (double-blind) D56, D84 (open-label) | — |
Countries
Estonia, France, Lithuania, Poland
Contacts
Public ContactCarine FABRE
PIERRE FABRE MEDICAMENT
Outcome results
None listed