None listed
Conditions
Brief summary
The purpose of this study is to determine if two cosmetic products, a cleanser and a moisturiser, containing ceramides can be of benefit for those with moderate eczema. It is hypothesised that daily use of such products will be of benefit as part of the maintenance regimen for those with moderate eczema.
Interventions
The will investigate the efficacy of two cosmetic products, a ceramide-dominant physiological lipid-based hydrating cleanser and moisturiser. The Cream will be applied liberally to the whole body twice a day, while the Cleanser will be used on the whole body once a day. Duration of use will be for 28 days. Compliance will be monitored by weighing the products at each study visit. Both products are regulated as cosmetics, and as such do not have 'active' ingredients. Both products contain ceram
The will investigate the efficacy of two cosmetic products, a ceramide-dominant physiological lipid-based hydrating cleanser and moisturiser. The Cream will be applied liberally to the whole body twice a day, while the Cleanser will be used on the whole body once a day. Duration of use will be for 28 days. Compliance will be monitored by weighing the products at each study visit. Both products are regulated as cosmetics, and as such do not have 'active' ingredients. Both products contain ceramides, cholesterol and physiological lipids in a 3:1:1 ratio.
Sponsors
Ego Pharmaceuticals Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed