A randomised, double blind, placebo controlled comparative trial of Ceramide Cream and Ceramide Cleanser in the management of moderate eczema in adults

Not Applicable

Completed

• Conditions: Eczema; Skin - Dermatological conditions

• Registration Number: ACTRN12615000782538
• Lead Sponsor: Ego Pharmaceuticals Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-28
• Study Completion: 2019-10-31
• Last Update Posted: 24 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or females over 18 years of age.
2. A confirmed diagnosis of eczema according to the criteria of Hanifin & Rajka for at least one year, with moderate severity (score of 10-20) as evaluated with the EASI.
3. Free of any dermatological or systemic disorder which could interfere with the results, at the discretion of the Investigator.
4. Free of any acute or chronic disease that may interfere with or increase the risk of study participation.
5. Completed a preliminary medical history form.
6. Have read, understood and signed an informed consent document relating to the specific type of study they are subscribing.
7. Able to cooperate with the Investigator and research staff, willing to have the test materials applied according to the protocol, and complete the full course of the study.

Exclusion Criteria

1. Individuals under 18 years of age.
2. History of allergies or adverse reactions to moisturisers or the components of the specific products being tested.
3. Use of other moisturising products or other topical eczema therapies in the week prior to participation in this trial.
4. Use of other moisturising products or other topical eczema therapies during the trial.
5. Individuals taking any medication (topical or systemic) that may mask or interfere with the test results, i.e. calcineurin inhibitors, oral corticosteroids.
6. A history of any acute or chronic disease that may interfere with or increase the risk of study participation.
7. Excessive hair on the test sites.
8. Individuals diagnosed with chronic skin allergies.
9. Pregnant or nursing females.

Study & Design

• Study Type: Interventional
• Study Design: Not specified