Atopic Dermatitis
Conditions
Brief summary
The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.
Interventions
DRUGLEO 39652 cream
Applied for 21 days
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) * Two symmetrical and comparable Entire Treatment Areas, on the same body region (left and right part) * Subjects must be in good health * Female subjects of childbearing potential and male subjects must be willing to consent to using high effective methods of contraception
Exclusion criteria
* Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than atopic dermatitis), sunburn, hyper-or hypopigmentation, scars * Dark-skinned persons (i.e. skin type IV to VI according to Fitzpatrick classification system) whose skin colour prevents reliable clinical assessments * Any permanent (or transient within 28 days prior to dosing) disease (in particular cardiac disease such as heart failure or history of myocardial infarction) that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments * Subjects with congenital or acquired immunodeficiencies or in subjects on therapy that causes immunosuppression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total sign score at end of treatment | 22 days | Total Sign Score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores(erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness)for each assessed area. |
Secondary
| Measure | Time frame |
|---|---|
| Total sign score on limited treatment area | 22 days |
| Investigator's treatment area assessment of disease severity | 22 days |
| Subject´s treatment area assessment of disease severity | 22 days |
| Subject´s assessment of itching | 22 days |
| Transepidermal Water Loss | 22 days |
Countries
Germany
Outcome results
None listed