Diagnosis of atopic dermatitis graded as mild to moderate according to the Rajka and Langeland system. MedDRA version: 12.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis
Conditions
Interventions
Product Name: LEO 29102 0,03mg/g
Product Code: LEO 29102
Pharmaceutical Form: Cream
INN or Proposed INN: LEO 29102
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of atopic dermatitis defined according to Hanifin and Rajka. 2. IGA assessment scored as mild (2) to moderate (3) atopic dermatitis. 3. Treatment lesions located on the trunk and/or limbs. 4. Treatment lesions involving 3% to 10% of the total body surface area. 5. Patients of either gender between 18 years and 65 years of age. 6. Female patients on: - hormonal contraceptives (used as a pill, patch, ring and implant or as an injection) for at least one menstrual cycle prior to randomisation: * combined contraceptives containing both an estrogen and a progestin * progestogen-only contraceptives containing only progesterone or a synthetic analogue (progestin) - intra uterine devices which are combined with a hormone for at least one menstrual cycle prior to randomisation in Germany, contraceptive regimens must have been used for at least 12 weeks before Visit 1, and the patients must agree to continue their contraception during the trial and for 1 month after the last application of an investigational product in this trial. 7. Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any study related activity is carried out, including activities relating to the washout period. Are the trial subjects under 18? no Number of subjects for this age range: 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Systemic treatment with immunosuppressive drugs (e.g., methotrexate, cyclosporine, azathioprine) or corticosteroids within 6 weeks prior to randomisa- tion. (Inhaled or in-tranasal steroids corresponding to doses up to 1 mg prednisone may be used). 2. Topical treatment with immunomodulators (pimecrolimus, tacrolimus) within 2 weeks prior to randomisation. 3. Topical treatment with corticosteroids from WHO groups II, III or IV within 1 week prior to randomisation. 4. Use of topical or systemic antibiotics within 2 weeks prior to randomisation. 5. Other topical therapy on the treatment areas within 1 week prior to randomisation. Note: use of emollient is permitted on AD lesion during a washout period only and on body areas not to be treated with investigational product. Use of hydrocortisone cream 1% is permitted on AD lesions on the face, neck and hands. 6. Change in systemic anti-histamine therapy within two weeks prior to randomisation, i.e., the patients should not start anti-histamine treatment or change current dosage regimen within two weeks prior to randomisation. 7. PUVA or UVB therapy within 4 weeks prior to randomisation. 8. Clinical infection (viral, fungal or bacterial) on the treatment area. 9. Known or suspected severe renal insufficiency or severe hepatic disorders. 10. Patients with history of an immunocompromised disease (e.g., lymphoma, HIV, Wiskott-Aldrich Syndrome). 11. Patients with concomitant serious disease (e.g., cancer) which might affect the AD treatment in this trial. 12. Planned extensive sun exposure of treatment areas during trial participation (e.g., sun bathing, use of solarium, etc.). 13. Known or suspected hypersensitivity to component( s) of the investigational product or comparator (Elidel® cream (pimecrolimus) 10 mg/g). 14. Females who are pregnant or are breast feeding. 15. Females intending to temporarily or permanently stop their hormonal contraceptive regime during and up to one month post study termination Visit. 16. Current or within 4 weeks participation in any other interventional clinical trial. 17. Previously randomised in this study. 18. In the opinion of the Investigator unlikely to comply with the Clinical Study Protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to identify the optimal dose of 5 different strength of LEO 29102 in the treatment of patients with the clinical diagnosis of atopic dermatitis graded as mild to moderate according to the Rajka and Langeland system.;Secondary Objective: The secondary objectives are to compare and describe the efficacy of each of the 5 dose strengths of LEO 29102 cream, LEO cream vehicle and Elidel® 10 mg/g cream (pimecrolimus) with regards to: • EASI (Eczema Area and Severity Index) • Investigator Global Assessments (IGA) of disease severity • symptom free responders • pruritus • erythema • oedema/induration/papulation • excoriation • lichenification • time to permanent response • patient overall assessment of disease severity and to compare and to describe the safety and local tolerance profile.;Primary end point(s): End-points The primary end-point will be measuring treatment efficacy as defined as the change in EASI (Eczema Area and Severity Index) at end of treatment (Visit 5) as compared to baseline. EASI is a composite score based on the evaluation of 4 characteristic atopic dermatitis signs and symptom; erythema, induration/papulation, excoriation, lichenification together with the area involved. EASI is a well established and used scoring method in atopic dermatitis. As of today no objective assessment of AD exist and it is therefore of importance that all evaluation of the signs and symptoms are performed by trained dermatologists. | — |
Countries
Finland, Germany
Outcome results
None listed