Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis
NCT ID: NCT01691209
Last Updated: 2013-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-10-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Phoenix
Application over 29 days twice daily
Phoenix (BAY81-2996)
Topical formulation applied to the skin
Hydrocortison
Application over 29 days twice daily
1% Hydrocortison cream
1% Hydrocortison cream applied to the skin
Untreated skin
Participants will be observed over 29 days without study treatment
No interventions assigned to this group
Interventions
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Phoenix (BAY81-2996)
Topical formulation applied to the skin
1% Hydrocortison cream
1% Hydrocortison cream applied to the skin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer HealthCare AG, Consumer Care
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Münster, North Rhine-Westphalia, Germany
Countries
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Other Identifiers
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2012-001504-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16200
Identifier Type: -
Identifier Source: org_study_id