Dermatitis, Atopic
Conditions
Keywords
Phoenix, Hydrocortison, mild atopic dermatitis, efficacy, safety
Brief summary
The study shall explore whether treatment of atopic dermatitis is equally effective with Phoenix medical device as compared to standard therapy (Hydrocortisone cream).
Interventions
DEVICEPhoenix (BAY81-2996)
Topical formulation applied to the skin
DRUG1% Hydrocortison cream
1% Hydrocortison cream applied to the skin
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 atopic dermatitis (AD) 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 with the clinical assessment in the opinion of the investigator * Moles, tattoos, strong pigmentation, or scars at the test area that would interfere with the clinical assessment * Regular intake of antiphlogistic drugs (for example nonsteroidal anti-inflammatory drugs \[NSAIDs\]) * 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
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with abnormal vital signs | Up to 10 weeks | Vital signs consist of blood pressure, heart rate and body temperature. |
| Number of participants with adverse events as a measure of safety and tolerability | Up to 10 weeks | — |
Other
| Measure | Time frame |
|---|---|
| Skin hydration by means of corneometry | Up to 29 days |
| Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index | Up to 29 days |
| Intensity of pruritus by means of visual analogue scale (VAS) | Up to 29 days |
| Erythema by means of chromametry | 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