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Trial registered on ANZCTR


Registration number
ACTRN12620000160932
Ethics application status
Approved
Date submitted
7/02/2020
Date registered
14/02/2020
Date last updated
1/07/2021
Date data sharing statement initially provided
14/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pivotal in vivo bioequivalence study comparing two formulations of methylprednisolone aceponate fatty ointment applied to the skin in healthy male and female volunteers.
Scientific title
A pivotal in vivo bioequivalence study comparing two formualtions of methylprednisolone aceponate fatty ointment, using the appropriate dose duration (ED50) calculated from the Pilot dose duration-response study, using healthy male and female volunteers who meet the responder and detector criteria.
Secondary ID [1] 292350 0
Nil
Universal Trial Number (UTN)
U1111-1225-6829
Trial acronym
Linked study record
ACTRN12619000510145 is the pilot study of this study.

Health condition
Health condition(s) or problem(s) studied:
Methylprednisolone aceponate fatty ointment 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. 316023 0
Condition category
Condition code
Skin 314299 314299 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 methylprednisolone aceponate fatty ointment (0.1% w/w) and 10 mg (5mg/cm2) per site of the innovator formulation of methylprednisolone aceponate fatty ointment (0.1% w/w). The intervention for this trial is the test formulation of 1 mg/g (0.1% w/w) methylprednisolone aceponate fatty ointment

Subjects will be healthy subjects who have shown a vasoconstriction response to a single dose of Advantan Ointment

The test and reference ointment will be applied to pre-allocated sites at times determined from the pilot study results (ACTRN12619000510145).

The ointment is then removed from all sites 5 hours after the first application 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.

Ointment 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] 316681 0
Treatment: Other
Intervention code [2] 316682 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 1 mg/g (0.1% w/w) methylprednisolone aceponate fatty ointment and the innovator formulation of 1 mg/g (0.1% w/w) methylprednisolone aceponate fatty ointment at various dose durations applied to 6 sites on each arm. The comparator/control for this trial is the innovator formulation of methylprednisolone aceponate fatty ointment.

Two sites per arm are untreated.


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

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

Outcomes
Primary outcome [1] 322688 0
To compare the in vivo bioequivalence of two formulations of methylprednisolone aceponate fatty ointment (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] 322688 0
Ointment 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] 379299 0
Safety of the two formulations will be assessed.
Timepoint [1] 379299 0
Assessed throughout the study days by observing the skin and asking participants if they are experiencing any side effects.

Eligibility
Key inclusion criteria
Males or females
In good general health
Show a vasoconstriction response to a single dose of Advantan Ointment
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 has ointment applied at time points determined by the Pilot Study e.g. 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
17/02/2020
Actual
11/02/2020
Date of last participant enrolment
Anticipated
Actual
10/03/2020
Date of last data collection
Anticipated
Actual
15/03/2020
Sample size
Target
90
Accrual to date
Final
95
Recruitment outside Australia
Country [1] 22282 0
New Zealand
State/province [1] 22282 0
Otago

Funding & Sponsors
Funding source category [1] 296907 0
Commercial sector/Industry
Name [1] 296907 0
Aspen Australia
Country [1] 296907 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 295909 0
None
Name [1] 295909 0
Address [1] 295909 0
Country [1] 295909 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298117 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 298117 0
Ethics committee country [1] 298117 0
New Zealand
Date submitted for ethics approval [1] 298117 0
19/12/2018
Approval date [1] 298117 0
10/04/2019
Ethics approval number [1] 298117 0
19/STH/5

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

Contacts
Principal investigator
Name 76050 0
Dr Noelyn Hung
Address 76050 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin 9016
Country 76050 0
New Zealand
Phone 76050 0
+64 3 477 9669
Fax 76050 0
+6434779605
Email 76050 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 76051 0
Linda Folland
Address 76051 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin 9016
Country 76051 0
New Zealand
Phone 76051 0
+64 3 477 9669
Fax 76051 0
+6434779605
Email 76051 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 76052 0
Tak Hung
Address 76052 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin 9016
Country 76052 0
New Zealand
Phone 76052 0
+64 3 477 9669
Fax 76052 0
+6434779605
Email 76052 0
tak.hung@zenithtechnology.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be compiled into a final report that is the property of the sponsor company. All participant data will be provided in summary format and result of the study only will be reported.


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.