A Comparison study of moisturizing creams in prevention of relapse of atopic dermatitis. A randomised, double blind study with Canoderm containing moisturiser as active substance in comparison with the reference cream without active substance.

• Conditions: Atopic dermatitis; MedDRA version: 14.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-001068-23-NO
• Lead Sponsor: ACO Hud Nordic AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1) Willing and able to provide informed consent
2) Male or female and aged 18 years or above
3) Diagnosis of AD according to UK working party 1994 (27), i.e.:
a) Any itching skin condition
and
b) Three or more of the following:
i) History of flexural involvement, e.g. front of elbows, behind the knees, front of ankles, around the neck
ii) Personal history of other atopic disease, e.g. asthma or hay fever
iii) History of a generally dry skin in the last 12 months
iv) Visible flexural dermatitis, e.g. front of elbows, behind the knees, front of ankles, around the neck
v) Onset below age 2
4) Visible atopic eczema of body surface area corresponding to a total area of at least the size of one palm of the patient’s hand
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Eczema exclusively on the hands
2) Hypersensitivity or allergy to the test product (Canoderm), to the reference product (base cream), to the products used in the stabilisation phase (Miniderm, hydrocortisone cream 1%,
mometasone furoate cream 0.1%), or to chemically related products
3) Any serious current medical condition which, in the opinion of the Investigator, may interfere with the evaluation of the results or may be contraindicated by the use of the test medications
4) Use of any concomitant medication that may interfere with the study related activities or
assessment of efficacy, as judged by the Investigator
5) Female patient who, according to the patient, is pregnant or breast-feeding, or plans to become pregnant during the course of the study
6) Any patient-related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse), as judged by the Investigator
7) Enrolment in any investigational study or use of an investigational drug within 3 months prior
to the screening visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to show that a barrier strengthening moisturiser is superior to a base cream in preventing eczema relapse in patients with AD.;Secondary Objective: The secondary objective is to study the QoL during different stages of AD.;Primary end point(s): The primary endpoint of the study is to examine the time between randomisation and a subsequent event of relapse, measured as a hazard ratio. The hazard ratio is an expression of the hazard of events occurring in the base cream group as ratio of the hazard of events<br>occurring in the Canoderm group.;Timepoint(s) of evaluation of this end point: Time between randomisation and a subsequent event of relapse.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary efficacy endpoints are:<br> Clinical<br>-Time to relapse of atopic eczema (days)<br>- Proportion of patients still eczema free after 3 months maintenance treatment<br>- Proportion of patients still eczema free after 6 months maintenance treatment<br>- Absolute and relative risk reduction<br>- The relapse rate ratio, i.e. the number of relapses divided by the total number of person time at risk<br>- Cream consumption of maintenance treatment<br>QoL<br>- EQ-5D™<br>Safety endpoint is rate of AEs.;Timepoint(s) of evaluation of this end point: - Time to relapse<br>- At 3 months maintenance treatment<br>- At 6 months maintenance treatment<br>- <br>- Cream consumption will be based on the weight of the reference and test creams before (Visit 2/2b) and after use (Visit 4).<br>-EQ-5D™ will be completed by the patients at Visits 1-4.<br>- AEs will be recorded from Visit 2 to the completion of Visit 4.