NCT01691209
Withdrawn
Not Applicable
An Investigator-blinded, Randomized, Monocentre, 3-arm, Active Controlled Pilot Trial to Explore the Efficacy and Safety of a Topical Medical Device in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With a Standard Therapy (1% Hydrocortisone Cream) and Untreated Skin
ConditionsDermatitis, Atopic
Overview
- Phase
- Not Applicable
- Intervention
- Phoenix (BAY81-2996)
- Conditions
- Dermatitis, Atopic
- Sponsor
- Bayer
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Phoenix
Application over 29 days twice daily
Intervention: Phoenix (BAY81-2996)
Hydrocortison
Application over 29 days twice daily
Intervention: 1% Hydrocortison cream
Outcomes
Primary Outcomes
Not specified
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