EO19123 Cream in the Treatment of Atopic DermatitisA Phase II, proof of concept study, testing once daily use of two dose-combinations of LEO19123 cream (calcipotriol and LEO80122) in the treatment of atopic dermatitis - LEO19123 Cream in the Treatment of Atopic Dermatitis

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 75

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 erythema, induration/papulation, excoriation and lichenification, four of the five clinical signs in Total Severity Score should at least correspond to moderate, i.e. severity =2 at Visit 1
4. Treatment area amenable to topical treatment
5. Patients should be males between 18-50 years
6. 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

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>;Primary end point(s): The absolute change in Total Severity Score on the target area (the arms) from baseline to end of treatment.

Secondary Outcome Measures

Name	Time	Method

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