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

Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: 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. CONDITION: Infected Dermatoses PRIMARY OUTCOME: Part 1 ; ; Objective: To evaluate the dose‐duration response relationship for single doses of mometasone furoate cream and estimate its ED50 (duration at which chromameter readings are half maximal) ; ; Measured by: quantification of skin blanching via chromameter readings Part 2 ; Objective: To assess the relative vasoconstrictive potency of MK‐0887G in comparison to the marketed Mometasone Furoate Cream. ; ; Measured by: quantification of skin blanching via chromameter readings SECONDARY OUTCOME: Part 2: ; Objective: To assess the safety and tolerability of single doses of MK‐0887G ; ; Measured by: Laboratory safety tests (haematology, chemistry), urinalysis, physical examination, Electrocardiogram (ECG), Vital signs (heart rate, blood pressure, respiratory rate, oral/tympanic temperature) and assessment of adverse events 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
Epistemonikos ID: 082764a6d77ed0edb163df5d087193339a20e76e
First added on: Aug 25, 2024