Atopic Eczema
Conditions
Interventions
Trade Name: E45 Cream
Pharmaceutical Form: Cream
INN or Proposed INN: Anhydrous Lanolin
CAS Number: 8006-54-0
Other descriptive name: Wo
Sponsors
Reckitt Benckiser Healthcare International
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of E45 complete emollient therapy against an unchanged emollient regime along with the role of E45 anti itch cream in controlling itch. This will be evaluated through validated quality of life questionnaires, investigators global assessment and diary cards.;Secondary Objective: The secondary objective is to compare the tolerability of an E45 regime and the itch cream against an unchanged emollient regime. This will be evaluated through the collection of adverse events and a patient satisfaction questionnaire.; Primary end point(s): The study will look at two primary efficacy endpoints. The first, to assess the overall efficacy of the E45 emollient therapy regime, is the change in validated quality of life score (children’s dermatology life quality index (CDLQI)) from baseline to week 6, comparing treatment groups A and C. The second, to assess the efficacy of the E45 itch relief cream, is the cumulative change in the itch-severity visual analogue scale over the course of the study, comparing treatment groups A and B. Secondary efficacy endpoints include: · changes in the quality of life score at weeks 1 and 3 · changes in the itch visual analogue scale by week · changes in the dermatitis family impact questionnaire · changes in the IGA · changes in the itch 4-point grading scale · changes in the subjective global assessment (SGA) · the number of eczema flares recorded (defined as an IGA > or = 3) Safety endpoints will include the incidence of all adverse events, serious adverse events, and treatment-related adverse events. | — |
Countries
United Kingdom
Outcome results
None listed