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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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2009-11-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm 1
Sinecort cream
Application over 29 days
Arm 2
Hydrocortison cream
Application over 29 days
Arm 3
Untreated skin
Interventions
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Sinecort cream
Application over 29 days
Hydrocortison cream
Application over 29 days
Untreated skin
Eligibility Criteria
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Inclusion Criteria
* Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25
* Skin type I - IV according to Fitzpatrick
* Acute AD symptoms on each assessment areas (local SCORAD \>/=3 and \<= 12)
* Acute symptom of pruritus at Baseline
Exclusion Criteria
* Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
* Regular intake of antiphlogistic drugs (for example, 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
65 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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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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2008-008136-82
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13932
Identifier Type: -
Identifier Source: org_study_id
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