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Trial registered on ANZCTR


Registration number
ACTRN12612001081808
Ethics application status
Approved
Date submitted
9/10/2012
Date registered
9/10/2012
Date last updated
10/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 281355 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infected Dermatoses 287576 0
Condition category
Condition code
Skin 287901 287901 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 285818 0
Treatment: Drugs
Comparator / control treatment
Part 1: No treatment (Non-active control)

Part 2:
-Mometasone furoate Cream (0.1%) (Active control)
-No treatment (Non-active control)
Control group
Active

Outcomes
Primary outcome [1] 288121 0
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
Timepoint [1] 288121 0
Time points: predose, 1, 2, 4, 6, 8, 10, 12, 20, 22, 24 & 30hrs post dose.
Primary outcome [2] 288122 0
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
Timepoint [2] 288122 0
Time points: predose, 1, 2, 4, 6, 8, 10, 12, 20, 22, 24 & 30hrs post dose.
Secondary outcome [1] 299457 0
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
Timepoint [1] 299457 0
Time points (laboratory safety tests, urinalysis, physical examination, ECG, vital signs): pre-dose & Day 2

Time points (Adverse events): pre-dose, Day 1, Day 2 and Day 15 (recorded in an ongoing fashion but at minimum elucidated at these timepoints)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects randomised and given a 'randomisation/allocation number' in the order in which they qualify. Subjects allocated treatment based on an allocation schedule. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
6/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286120 0
Commercial sector/Industry
Name [1] 286120 0
Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
Country [1] 286120 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp and Dohme Corp, a subsidiary of Merck & Co., Inc.
Address
One Merck Drive
Whitehouse Station, NJ, 08889-010
Country
United States of America
Secondary sponsor category [1] 284933 0
None
Name [1] 284933 0
Address [1] 284933 0
Country [1] 284933 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288167 0
Ethics committee address [1] 288167 0
Ethics committee country [1] 288167 0
Date submitted for ethics approval [1] 288167 0
29/08/2012
Approval date [1] 288167 0
Ethics approval number [1] 288167 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34796 0
Dr Sepehr Shakib
Address 34796 0
CMAX- A division of IDT Australia
Royal Adelaide Hospital
Level 5 East Wing
Nth Terrace, Adelaide
SA 5000
Country 34796 0
Australia
Phone 34796 0
+61882223935
Fax 34796 0
Email 34796 0
[email protected]
Contact person for public queries
Name 18043 0
Louise Pirc
Address 18043 0
CMAX – A division of IDT Australia
Royal Adelaide Hospital
Level 5 East Wing
North Terrace
Adelaide, SA, 5000
Country 18043 0
Australia
Phone 18043 0
+61882223935
Fax 18043 0
Email 18043 0
[email protected]
Contact person for scientific queries
Name 8971 0
Sepehr Shakib
Address 8971 0
CMAX – A division of IDT Australia
Royal Adelaide Hospital
Level 5 East Wing
North Terrace
Adelaide, SA, 5000
Country 8971 0
Australia
Phone 8971 0
+61882223935
Fax 8971 0
Email 8971 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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