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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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001081808
Enrollment
192
Registered
2012-10-09
Start date
2012-11-06
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A Single Exposure Trial to Evaluate the Dose Duration Response of Mometasone Furoate Cream and Vasoconstrictive Activity of MK0887G Topically applied to the skin of Healthy Subjects MK0887G (fixed dose cream) is being developed for the treatment of infected dermatoses. However, this study is in healthy volunteers only.

Interventions

Part 1 Treatment: Mometasone Furoate Cream (0.1%) 20mg/application site (5mg/cm2), single dose topical All participants will receive the above treatment applied to a total of 16 sites (2x2cm2) on the inner aspect of their forearms (8 per arm). Four additional sites will be marked but will remain untreated to act as non-dosed control sites. Mometasone furoate cream will be applied to test sites at staggered timepoints followed by synchronized removal from all test sites to achieve treatment du

Part 1 Treatment: Mometasone Furoate Cream (0.1%) 20mg/application site (5mg/cm2), single dose topical All participants will receive the above treatment applied to a total of 16 sites (2x2cm2) on the inner aspect of their forearms (8 per arm). Four additional sites will be marked but will remain untreated to act as non-dosed control sites. Mometasone furoate cream will be applied to test sites at staggered timepoints followed by synchronized removal from all test sites to achieve treatment durations of 15, 30, 45, 60, 90, 120, 240 & 360 minutes. Part 2 Treatments: Reference Treatment: Mometasone Furoate Cream (0.1%), 20mg per application site (5mg/cm2), single dose topical Test Treatment: MK-0887G 20mg/application site (5mg/cm2), single dose, topical All subjects will receive the same treatments which includes both the reference and test treatments as well as untreated control sites across a total of 20 sites (2cm x 2cm) marked on the volar aspect of the forearms (10 sites per arm). The reference and test treatments will be applied to test sites at staggered time points followed by synchronized removal from all test sites to achieve treatment durations (3 different durations for mometasone furoate and a single duration for MK0887G). The durations for the treatments have not yet been identified but will be deduced from the results of part 1 of the study. The position of reference and test treatment sites will be determined by the randomization code. MK0887G (fixed dose cream) is being developed for the treatment of infected dermatoses. However, this study is in healthy volunteers only.

Sponsors

Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

-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

Exclusion criteria

-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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026