LONG-TERM MANAGEMENT OF ATOPIC DERMATITIS WITH THE EMOLLIENT V0034 CR. A RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUPS, DOUBLE-BLIND STUDY IN INFANTS AND CHILDREN - Not applicable

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003396-21-EE

Enrollment

300

Registered

2005-09-20

Start date

2005-11-03

Completion date

Unknown

Last updated

2012-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients presenting with an atopic dermatitis, out of flare at the inclusion. MedDRA version: 8.0 Level: LLT Classification code 10040785

Interventions

Trade Name: DEXERYL crème Product Name: DEXERYL crème Product Code: V0034 CR 01B Pharmaceutical Form: Cream INN or Proposed INN: Glycerol CAS Number: 56-81-5 Concentration unit: % percent Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients, male or female, presenting with the following criteria may be included: - age between 3 months and 7 years included - presenting with an atopic dermatitis according to the diagnostic criteria of the UK Working party - whose IGA score is =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients presenting with any of the following criteria will not be included: * Criteria related to pathologies· - Acute phase of atopic dermatitis with moderate/severe erythema, excoriation, crust, oozing, exsudation, - Severe evolutive form of atopic dermatitis requiring systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation, - Dermatological disease other than atopic dermatitis liable to interfere with the assessment, - History of serious disease considered by the investigator hazardous for the patient or incompatible with the study, - Immunosupression, - History of allergy or intolerance to cosmetics. * Criteria related to treatments· - Use of oral corticosteroids or immunosuppressants since less than 1 month, - Use of antibiotics, topical corticosteroids since less than 15 days,· - Use of non-steroid anti-inflammatory drugs or antihistamines since less than 1 week.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the overall benefit of a regular treatment by the emollient V0034CR in the management of atopic dermatitis: reduction of corticosteroids consumption, reduction of flares;Secondary Objective: To evaluate the Quality of Life over the study duration To evaluate the product effect on the skin dryness and pruritus To document the clinical, local and systemic, safety over the study duration;Primary end point(s): Number of days of application of a moderately potent corticosteroid	—

Measure

Time frame

Main Objective: To evaluate the overall benefit of a regular treatment by the emollient V0034CR in the management of atopic dermatitis: reduction of corticosteroids consumption, reduction of flares;Secondary Objective: To evaluate the Quality of Life over the study duration To evaluate the product effect on the skin dryness and pruritus To document the clinical, local and systemic, safety over the study duration;Primary end point(s): Number of days of application of a moderately potent corticosteroid

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Countries

Estonia, Finland, Germany, Latvia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026