Status:
COMPLETED
Sinecort Pilot Efficacy Study
Lead Sponsor:
Bayer
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study shall prove whether treatment of atopic dermatitis is equally effective with Sinecort cream as compared to standard therapy (Hydrocortisone cream).
Eligibility Criteria
Inclusion
- Male or female Caucasians aged between 18 and 65 years
- 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
- 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, 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00980135
Start Date
November 1 2009
End Date
May 1 2010
Last Update
April 2 2014
Active Locations (1)
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1
Münster, North Rhine-Westphalia, Germany, 48155