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Trial registered on ANZCTR


Registration number
ACTRN12615000815561
Ethics application status
Approved
Date submitted
10/07/2015
Date registered
7/08/2015
Date last updated
21/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pivotal in vivo bioequivalence study of comparing Eumovate cream to clobetasone butyrate cream applied to the skin in healthy male and female volunteers.
Scientific title
A pivotal in vivo bioequivalence study comparing Eumovate cream to Clobetasone butyrate cream, using the appropriate dose duration (ED50) for Eumovate cream calculated from the Pilot dose duration-response study, using healthy male and female volunteers who meet the responder and detector criteria.
Secondary ID [1] 287053 0
Nil
Universal Trial Number (UTN)
U1111-1170-4025
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
A pivotal in vivo bioequivalence study conducted in healthy volunteers with no health condition or problem studied.

This 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.
 295533 0
Condition category
Condition code
Skin 295810 295810 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multiple dose study design whereby each participant receives 10 mg (5mg/cm2) per site of the test formulation of clobetasone butyrate 0.5mg/g (0.05% w/w) cream and 10 mg (5mg/cm2) per site of the innovator formulation of clobetasone butyrate 0.5mg/g (0.05% w/w) cream. The intervention for this trial is the test formulation of 0.5mg/g (0.05%w/w) clobetasone butyrate cream.

Subjects will be healthy subjects who have shown a vasoconstriction response to a single dose of Eumovate cream.

The test and reference cream will be applied to pre-allocated sites at times determined from the pilot study results (ACTRN12615000723583) on the same day (no washout period). Based on the results of the pilot study the Reference cream will be applied to one site at 10.20am (D2), two sites at 11.40am (ED50) and one site at 12.20pm (D1) and the Test cream will be applied to two sites at 11.40 am (ED50), total of 6 treatment sites.

The cream is then removed from all sites at 1.00pm 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.

There will be 16 sites in total (8 on each arm whereby 6 sites will be treated with the test or reference cream and 2 sites will be untreated control sites).

All application times will be recorded and checked in individual subjects Case Report Forms.

Cream is applied by a trained staff member using pre-filled applicators.

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] 292279 0
Treatment: Other
Intervention code [2] 292364 0
Treatment: Drugs
Comparator / control treatment
Multiple dose study design whereby each participant receives 10 mg (5mg/cm2) per site of the test formulation of clobetasone butyrate 0.5mg/g (0.05% w/w) cream and the innovator formulation of Eumovate 0.5mg/g (0.05% w/w) cream at various dose durations applied to 6 sites on each arm. The comparator/control for this trial is the innovator formulation of clobetasone butyrate cream, Eumovate Cream.

Two sites per arm are untreated.


All application times will be recorded and checked in individual subjects Case Report Forms.

Cream is applied by a trained staff member using pre-filled applicators.
Control group
Active

Outcomes
Primary outcome [1] 295505 0
To compare the in vivo bioequivalence of clobetasone butyrate 0.05% w.w cream and Eumovate cream (as summarised by AUEC (Area Under the Effect Curve)) using vasoconstriction. Blanching will be evaluated objectively using a Minolta CR30 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] 295505 0
Cream is applied at various times to 6 sites per arm.

Evaluation Time is 0, 2, 4, 6, 19 and 24 hours after cream removal.
Secondary outcome [1] 315722 0
None
Timepoint [1] 315722 0
None

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)
All formulations will be labelled as Formulation A and B. The identification of each treatment will only be known to the Managing Director and the Section Head - Trials and Regulatory Affairs.
Randomisation will be performed using a randomisation table created by computer software (i.e. computerised sequence generation).
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 are randomly assigned to each subject number
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
This is a single period, two treatment study where each subject at time points determined by the Pilot Study receives 2 test and 4 reference doses on each arm as well as 2 blank sites per arm.
Phase
Phase 1
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/07/2015
Actual
29/07/2015
Date of last participant enrolment
Anticipated
1/09/2015
Actual
28/08/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 7028 0
New Zealand
State/province [1] 7028 0
Otago

Funding & Sponsors
Funding source category [1] 291626 0
Commercial sector/Industry
Name [1] 291626 0
Ego Pharmaceuticals Pty Ltd
Country [1] 291626 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] 290298 0
None
Name [1] 290298 0
Address [1] 290298 0
Country [1] 290298 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293157 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 293157 0
Ministry of Health
Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 293157 0
New Zealand
Date submitted for ethics approval [1] 293157 0
Approval date [1] 293157 0
30/06/2015
Ethics approval number [1] 293157 0
15/NTB/94

Summary
Brief summary
To determine the in vivo bioequivalence of clobetasone butyrate cream to Eumovate cream using the ED50, D1 (Shorter dose duration reference listed drug calibrator) and D2 (Longer dose duration reference lised drug calibrator) results calculated in the pilot dose duration-response study (ACTRN12615000723583) using Eumovate cream.
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 58650 0
Dr Noelyn Hung
Address 58650 0
Zenith Technology Corporation Ltd
PO Box 1777
Dunedin 9054
Country 58650 0
New Zealand
Phone 58650 0
+6434779669
Fax 58650 0
+6434779605
Email 58650 0
[email protected]
Contact person for public queries
Name 58651 0
Linda Folland
Address 58651 0
Zenith Technology Corporation Ltd
PO Box 1777
Dunedin 9054
Country 58651 0
New Zealand
Phone 58651 0
+6434779669
Fax 58651 0
+6434779605
Email 58651 0
[email protected]
Contact person for scientific queries
Name 58652 0
Cheung-Tak Hung
Address 58652 0
Zenith Technology Corporation Ltd
PO Box 1777
Dunedin 9054
Country 58652 0
New Zealand
Phone 58652 0
+6434779669
Fax 58652 0
+6434779605
Email 58652 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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