Status:
COMPLETED
Comparative Safety Study of New Sinecort Formulation Versus Positive Control
Lead Sponsor:
Bayer
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study is focused to prove a favorable safety profile of the new formulation.
Eligibility Criteria
Inclusion
- Age of at least 18 years
- Skin type I, II, or III according to Fitzpatrick
- Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
Exclusion
- Clinical history suggestive of intolerance, allergies or idiosyncrasies to one of the products or the ingredients of the products including the patch.
- Known skin allergies.
- Dermatologic diseases that might interfere with the evaluation of test site reaction.
- Other(s), considered as important by the investigator (e.g. multiple birth marks in the test area, important hair growth in the test area, pigmented or extremely suntanned skin impairing visual assessment, tattoos in the test area.
- Topical use of any cosmetic preparation on the test areas within 5 days prior to Day 1 (Start of Treatment) or during the trial
- Within 3 weeks prior to Day 1 and during the entire trial. Any systemic or topical medication likely to interfere with the trial purposes: e.g. immune-modulating therapy (e.g. corticosteroids, cytotoxics or immunosuppressants) and any dermatological medication (drug or medical device.
- Within 1 week prior to Day 1 and during the entire trial any medication with common effects on the perfusion of skin vessels (e.g. vasodilators or vasoconstrictors, ß-receptor blocking drugs, antihistamines) should not be used.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00885937
Start Date
April 1 2009
End Date
May 1 2009
Last Update
June 23 2014
Active Locations (1)
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1
Münster, North Rhine-Westphalia, Germany, 48155