Dermatitis, Atopic
Conditions
Keywords
Phoenix, Mild atopic dermatitis, efficacy, safety
Brief summary
The study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device.
Interventions
DEVICEPhoenix II (BAY81-2996)
DEVICEPhoenix I (BAY81-2996)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male or female Caucasians aged between 18 and 60 years * Patients with mild to moderate AD (Atopic Dermatitis) presenting a scoring AD (SCORAD) rating below 50 * Skin type I - IV according to Fitzpatrick * Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and \</= 12) at Baseline * Acute symptom of pruritus at Baseline
Exclusion criteria
* Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator * Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment * Regular intake of antiphlogistic drugs (for example, nonsteroidal anti-inflammatory drug \[NSAIDs\]) * Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas) * UV-therapy or the use of solarium within 30 days before screening as well as during the trial * Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index | Up to 29 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events as a measure of safety and tolerability | Up to 10 weeks | — |
| Erythema by means of chromametry | Up to 29 days | — |
| Number of subjects with abnormal vital signs | Up to 10 weeks | Vital signs consist of blood pressure, heart rate, and body temperature |
| Skin hydration by means of corneometry | Up to 29 days | — |
| Intensity of pruritus by means of visual analogue scale (VAS) | Up to 29 days | — |
| Transepidermal water loss (TEWL) as a measure for skin barrier function | Up to 29 days | — |
Countries
Germany
Outcome results
None listed