Atopic Dermatitis
Conditions
Brief summary
The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO 32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.
Interventions
DRUGLEO 32731 cream
Applied for 3 weeks
DRUGLEO 32731 cream vehicle
Applied for 3 weeks
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures being carried out * Subject with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1) * Two symmetrically located and comparable Entire Treatment Areas (ETAs) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete AD lesion or part of an AD lesion); Total Sign Score (TSS) of at least 5 on both ETAs; difference in TSS not greater than 2 between the two ETAs; sign score for erythema ≥ 2 on both ETAs; difference in Investigator´s Treatment Area assessment of disease severity not greater than 1 between the 2 ETAs
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total sign score at end of treatment on entire treatment area | 3 weeks | 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 area |
Secondary
| Measure | Time frame |
|---|---|
| Investigator's treatment area assessment of disease severity on entire treatment area during trial | 3 weeks |
| Subject's treatment area assessment of disease severity on entire treatment area during trial | 3 weeks |
| Total sign score on limited treatment area on entire treatment area during trial | 3 week |
| Transepidermal water loss during trial | 3 weeks |
| Individual signs score on entire treatment during trial | 3 weeks |
| Subject's assessment of itching on entire treatment area during trial | 3 weeks |
Countries
Germany
Outcome results
None listed