Atopic dermatitis MedDRA version: 8.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis
Conditions
Interventions
Product Code: LEO19123
Pharmaceutical Form: Cream
INN or Proposed INN: Calcipotriol Hydrate
CAS Number: 147657-22-5
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentrat
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Signed informed consent has been obtained following verbal and written information about the trial 2. Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka (see Appendix III) 3. The score of each of the five clinical signs in Total Severity Score on the arms should be =2 (moderate) at Visit 1 4. Treatment area amenable to topical treatment 5. Male gender 6. Age between 18-50 years 7. Attending a hospital outpatient clinic or the private practice of a dermatologist 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 4 weeks prior to randomisation. (Inhaled or in-tranasal steroids for asthma or rhinitis may be used) 2. PUVA or UVB therapy within 4 weeks prior to randomisation 3. Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or cortico- steroids from WHO groups III or IV within 2 weeks prior to randomisation 4. Other topical therapy on the treatment area (except for the use of emollient on the entire body and hydrocortisone cream 1% on head and neck lesions) within 1 week prior to randomisation 5. Use of any other kind of treatment for AD (drug , non-drug) during the study except for the use of: - investigational product on trunk and limbs lesions only during the treatment phase - hydrocortisone cream 1% on head and neck lesions - emollient on the entire body 6. Use of anti-histamines during the study 7. Current diagnosis of exfoliative erythrodermia 8. Clinical infection (impetiginised atopic dermatitis) on the treatment area 9. Planned exposure to amount of sun or ultraviolet light during the study that may affect atopic dermatitis 10. Known or suspected hypersensitivity to component(s) of the investigational product 11. Known or suspected severe renal insufficiency or severe hepatic disorders 12. Patients with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia 13. Patients with history of cancer including skin cancer 14. Patients with history of an immunocompromised disease (e.g. lymphoma, HIV, Wiskott-Aldrich Syndrome) 15. Current participation in any other interventional clinical trial 16. Patients who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registra-tion) within 4 weeks prior to randomisation 17. Previously randomised in this study 18. Patient known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the clinical efficacy of LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with atopic dermatitis after once daily treatment for three weeks.;Secondary Objective: To compare the safety LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with atopic dermatitis after once daily treatment for three weeks. ;Primary end point(s): The absolute change in Total Severity Score on the target area (the arms) from baseline to end of treatment. | — |
Countries
Denmark, Finland, United Kingdom
Outcome results
None listed