Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000723583
Ethics application status
Approved
Date submitted
9/06/2015
Date registered
14/07/2015
Date last updated
21/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study of Eumovate cream applied to the skin in Healthy male and female volunteers.
Scientific title
A pilot dose duration-response study using Eumovate cream only to determine the appropriate dose duration (ED50) in healthy male and female subjects for use in the pivotal in vivo bioequivalence study.
Secondary ID [1] 286876 0
None
Universal Trial Number (UTN)
U1111-1170-3669
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pilot dose duration-response study conducted in healthy volunteers with no health condition or problem studied.

This pilot study is being conducted in healthy volunteers who are not being treated for the conditions that Eumovate cream is indicated for.

Eumovate cream is indicated for the short term (up to 7 days) treatment of the milder form of eczema, dermatitis and other steroid responsive skin conditions which do not require the use of a more active topical corticosteroid in children and adults.
 295278 0
Condition category
Condition code
Skin 295527 295527 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multiple dose study where each participant attends a single treatment session and receives Eumovate cream (clobetasone butyrate 0.5 mg/g (0.05% w/w)) at various dose durations. The intervention for this trial is the Reference Listed Drug (RLD) of Eumovate Cream (clobetasone butyrate 0.5 mg/g (0.05% w/w)).

Subjects will be healthy subjects who have shown a vasoconstriction response to a single dose of Eumovate cream. There will be 12 sites in total (6 on each arm) where 4 sites will be treated with the cream and 2 will be untreated control sites. The 8 treated sites (4 on each arm) will have 10 mg of cream applied at various dose-durations at 6, 4, 2, 1.5, 1, 0.75, 0.5 and 0.25 hours prior to cream removal. The cream is then removed from all sites and the Chromameter measurements for the pharmacodynamic responses of the topical corticosteroid will be carried out at 0, 2, 4, 6, 19 and 24 hours following removal.

Subjects who meet the inclusion and exclusion criteria will be included in this study. Pre and post study laboratory tests will be performed along with an ECG and medical evaluation. A follow up visit will also be completed to assess for safety.
Intervention code [1] 292056 0
Treatment: Other
Intervention code [2] 292109 0
Treatment: Drugs
Comparator / control treatment
No Treatment on two untreated sites
Control group
Active

Outcomes
Primary outcome [1] 295266 0
To determine the ED50 parameter of Eumovate cream (clobetasone butyrate 0.05%w/w) using the Minolta Chromameter. The values will be used to measure the degree of colour change of each treatment site using a formulation that will be calculated and plotted against time.
Timepoint [1] 295266 0
Cream Applications: 6, 4, 2, 1.5, 1, 0.75, 0.5 and 0.25 hours

Skin evaluations: Time 0, 2, 4, 6, 19 and 24 hours following cream removal
Primary outcome [2] 295324 0
To determine the D1 parameter of Eumovate cream (clobetasone butyrate 0.05%w/w) using the Minolta Chromameter. The values will be used to measure the degree of colour change of each treatment site using a formulation that will be calculated and plotted against time.
Timepoint [2] 295324 0
Cream Applications: 6, 4, 2, 1.5, 1, 0.75, 0.5 and 0.25 hours

Skin evaluations: Time 0, 2, 4, 6, 19 and 24 hours following cream removal
Primary outcome [3] 295325 0
To determine the D2 parameter of Eumovate cream (clobetasone butyrate 0.05%w/w) using the Minolta Chromameter. The values will be used to measure the degree of colour change of each treatment site using a formulation that will be calculated and plotted against time.
Timepoint [3] 295325 0
Cream Applications: 6, 4, 2, 1.5, 1, 0.75, 0.5 and 0.25 hours

Skin evaluations: Time 0, 2, 4, 6, 19 and 24 hours following cream removal
Secondary outcome [1] 315210 0
Not Applicable for this study
Timepoint [1] 315210 0
Not Applicable for this study

Eligibility
Key inclusion criteria
Males or females
In good general health
Aged between 18-55 years of age inclusive
BMI between 18 and 33 inclusive
Laboratory tests within normal ranges or assessed not significant by the Clinical Investigator
Normal ECG
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinically significant hypertension or circulatory disease and any clinically significant illness during the last four weeks prior to the entry into this study.
Caffeine intake greater than 500 mg per day prior to this study.
Who have been on a special diet, especially a low salt and/or fluid diet, during the 2 weeks prior to the first study day.
Use of topical Dermatologic drug therapy on ventral forearms.
Adverse reactions to topical or systemic corticosteroids.
Who require shaving of the ventral forearms.
Use of any vasoactive medication, prescription or over the counter that could modulate blood flow.
Use of any prescription medication within 2 weeks preceding entry into the study
Any obvious difference in skin colour between arms or any scarring on the forearms.
Females who are pregnant or lactating
Significant medical condition that could in the Investigator's opinion interfere with the study, or put the subject at significant risk
Participation in any drug or medical device study within 30 days of entering this study

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)
Treatment duration will be randomly allocated for each site and each subject.

No blinding of the Eumovate cream as there is only one formulation used for this study.

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will be identified by a 3 digit screening number which is determined by the order in which the participants give consent, ie the 1st participant to give consent is allocated 001. and a 2 digit subject number which is determined by simple randomisation using a computer generated true random number generator at www.random.org. The screening number will be issued once the participant has given written consent to participate in the study and the two digit subject number will be issued after acceptance into the study.

The Randomization Scheme is computer generated by Zenith and as such, treatment sequences were randomly assigned to each subject number
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study is 1 period, 1 formulation applied at multiple timepoints on 8 randomly allocated sites with 4 untreated sites (total of 12 sites over both arms). A total of 6 sites per arm i.e. 4 treatment sites per arm and 2 untreated site per arm.
Phase
Phase 1
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/06/2015
Actual
19/06/2015
Date of last participant enrolment
Anticipated
30/06/2015
Actual
19/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 6964 0
New Zealand
State/province [1] 6964 0
Otago

Funding & Sponsors
Funding source category [1] 291437 0
Commercial sector/Industry
Name [1] 291437 0
Ego Pharmaceuticals Pty Ltd
Country [1] 291437 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 290112 0
None
Name [1] 290112 0
Address [1] 290112 0
Country [1] 290112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292987 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 292987 0
Ministry of Health
Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 292987 0
New Zealand
Date submitted for ethics approval [1] 292987 0
Approval date [1] 292987 0
04/06/2015
Ethics approval number [1] 292987 0
15/STH/80

Summary
Brief summary
To determine the dose duration-response using Eumovate cream in healthy volunteers.
Trial website
Trial related presentations / publications
No presentations or citations available. Final CSR provided to Sponsor Company for Registration Purposes
Public notes

Contacts
Principal investigator
Name 57918 0
Dr Noelyn Hung
Address 57918 0
Zenith Technology Corporation Limited 156 Frederick Street Dunedin 9016
Country 57918 0
New Zealand
Phone 57918 0
+6434779669
Fax 57918 0
+6434779605
Email 57918 0
[email protected]
Contact person for public queries
Name 57919 0
Mrs Linda Folland
Address 57919 0
Zenith Technology Corporation Limited 156 Frederick Street Dunedin 9016
Country 57919 0
New Zealand
Phone 57919 0
+6434779669
Fax 57919 0
+6434779605
Email 57919 0
[email protected]
Contact person for scientific queries
Name 57920 0
Dr Cheung-Tak Hung
Address 57920 0
Zenith Technology Corporation Limited 156 Frederick Street Dunedin 9016
Country 57920 0
New Zealand
Phone 57920 0
+6434779669
Fax 57920 0
+6434779605
Email 57920 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.