Efficacy/Safety study to explore a new revised topical formulation in Atopic Dermatitis (Phoenix II)
The study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device.
- 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
- 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
Münster, Germany, 48155
E-mail: [email protected]
Phone: Not Available
An investigator-blinded, randomized, monocentre, 3-arm, pilot trial to compare the efficacy and safety of two topical medical devices in patients with mild to moderate atopic dermatitis in an intra-individual comparison with untreated skin