A 6 week, multi centre study to evaluate the efficacy and safety of E45 complete emollient therapy and E45 itch relief cream in the treatment of mild to moderate atopic eczema compared to a patients normal emollient regime defined as the frequent use of emollient/s (not containing lauromacrogols) listed in the BNF. - Harbour Study

Phase 1

• Conditions: Atopic Eczema

• Registration Number: EUCTR2006-000877-30-GB
• Lead Sponsor: Reckitt Benckiser Healthcare International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

Only patients to whom all of the following conditions apply will be included:
1.Age: 2-16 years of age
2.Sex: male and female
3.Primary diagnosis: A diagnosis of atopic eczema as defined by the UK working party criteria and confirmed by a general practitioner
4.Patients who are using one of the top ten emollients (excluding lauromacrogols) listed in the BNF (see Appendix VI).
5.Status: patients at an enrolled site whose diagnosis of atopic eczema is defined as mild to moderate by the Rajka and Langeland criteria (1989) (a score of 3 - 7.5) and for whom their IGA does not >/ = 3
6.Patients who have a body surface area of at least 2% affected by atopic eczema.
7.Patients for whom the adult with parental responsibility has given written informed consent and for who have themselves given concurrent assent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients to whom any of the following conditions apply must be excluded:
1.Patients who are pregnant or breast feeding.
2.Patients who have used topical treatments other than emollients for the treatment of their atopic dermatitis in the last 3 days prior to consent (this includes but is not limited to all topical steroid preparations, Protopic, Elidel, antibioitics)
3.Patients who have used any light or systemic treatments (including anti histamines) for the treatment of their atopic dermatitis in the past 28 days prior to consent.
4.Patients who are using or have used in the past 28 days prior to consent systemic corticosteroids for the treatment of any disease.
5.Patients who currently have or are suspected of previously having any disease (dermatological or other) that may interfere with the study protocol.
6.Those previously randomised into the study.
7.Those who have participated in a clinical trial in the previous 12 weeks prior to consent.
8.Patients who are using, intend to use or have used in the preceding 4 weeks prior to consent any alternative, homeopathic treatments.
9.Any previous history of allergy or known intolerance to any of the drugs or formulation constituents
10.Those unable in the opinion of the Investigator to comply fully with the study requirements.

Study & Design

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