A Single Exposure Clinical Trial to Evaluate the Dose Duration Response of Mometasone Furoate Cream and Vasoconstrictive Activity of MK0887G Topically applied to the skin of Healthy Subjects
- Conditions
- Infected DermatosesSkin - Dermatological conditions
- Registration Number
- ACTRN12612001081808
- Lead Sponsor
- Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 192
BMI between 18-32 kg/m2 inclusive
-Female of reproductive potential to have negative pregnancy test and agree to use double-barrier contraception
-Good health based on medical history, physical examination, vital sign measurements, ECG and laboratory assessments
-Non smoker
-Demonstrate an adequate vasoconstriction response to commercial mometasone furoate cream (visual score of 1 or greater)
-Be willing to abide by dietary/exercise restrictions
-Female who is pregnant or intending to become pregnant within 3 months, or currently breastfeeding
-History of clinically significant abnormalities or diseases
-History of cancer (malignancy)
-History of significant multiple and/or severe allergies or anaphylaxis
-Infectious disease within 4 weeks
-History of dermatitis, eczema or psoriasis
-Positive to Hepatitis B, C or HIV
-Positive drug screen
-Has had major surgery, donated or lost 1 unit of blood within 4 weeks
-Consumes excessive amounts of alcohol
-Active dermatitis, injuries or markings to the forearms
-Subjects who would require shaving of the forearms
-Obvious visual difference in skin color between arms
-Used concomitant medications within protocol specified intervals for different classes of drug
-Previous allergic or irritant reaction to topical corticosteroids or components of any topical formulation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method