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Trial registered on ANZCTR


Registration number
ACTRN12624000621516
Ethics application status
Approved
Date submitted
2/05/2024
Date registered
14/05/2024
Date last updated
25/08/2024
Date data sharing statement initially provided
14/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pivotal in vivo bioequivalence study comparing two formulations of betamethsone OV ointment applied to the skin in healthy male and female volunteers.
Scientific title
A pivotal in vivo bioequivalence study comparing two formulations of betamethsone OV 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] 311963 0
None
Universal Trial Number (UTN)
U1111-1298-4651
Trial acronym
Linked study record
This study is linked to ACTRN12623001181695 which determined the time points for this full pivotal bioequivalence study.

Health condition
Health condition(s) or problem(s) studied:
Diprosone OV ointment is indicated for the topical treatment of eczema and psoriasis in children and adults. 333564 0
Condition category
Condition code
Skin 330246 330246 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 betamethasone OV ointment (0.05% w/w) and 10 mg (5mg/cm2) per site of the innovator formulation of betamethasone OV ointment (0.05% w/w) . The composition of the test and innovator formulations will be the same except for the excipients of each formulation.

The intervention for this trial is the test formulation of 0.5 mg/g (0.05% w/w) betamethasone OV ointment.

Participants will be healthy participants who have shown a vasoconstriction response to a single dose of betamethasone OV ointment (0.05% w/w)

The test and reference ointment will be applied to pre-allocated sites at times determined from the pilot study results (ACTRN12623001181695) .
ED50 (optimal dose duration) - applied at approx 12.15pm
D1 (Shorter dose duration reference listed drug calibrator) - applied at approx 12.45pm
D2 (Longer dose duration reference listed drug calibrator) - applied at approx 11.30pm

All site applications will be performed by trained staff and the on site Supervisor will ensure adherence to the intervention.. 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 ointment and 2 sites will be untreated control sites).

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

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

Participants who meet the inclusion and exclusion criteria will be included in this study. Participants from the pilot study will be permitted to take part in this study as long as they meet all inclusion and exclusion criteria for this study including the requirement of a 30 day stand down period from previous participation. 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] 328420 0
Treatment: Drugs
Intervention code [2] 328421 0
Treatment: Other
Comparator / control treatment
Two sites per arm are untreated.
Control group
Active

Outcomes
Primary outcome [1] 337992 0
in vivo bioequivalence (as summarised by AUEC (Area Under the Effect Curve)) using vasoconstriction.
Timepoint [1] 337992 0
Ointment is applied at various times to 6 sites per arm and assessed at each evaluation time of 0, 2, 4, 6, 19 and 24 hours after ointment removal.
Secondary outcome [1] 434060 0
Safety
Timepoint [1] 434060 0
Assessed at each evaluation time of 0, 2, 4, 6, 19 and 24 hours after ointment removal.

Eligibility
Key inclusion criteria
Males or females
In good general health
Show a vasoconstriction response to a single dose of betamethasone OV 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 participant 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.

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 participant 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 participant number will be issued after acceptance into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a randomisation table created by computer software (i.e. computerised sequence generation).
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 participant has ointment applied at time points determined by the Pilot Study (ACTRN12623001181695) 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
16/05/2024
Actual
8/05/2024
Date of last participant enrolment
Anticipated
Actual
6/06/2024
Date of last data collection
Anticipated
Actual
13/06/2024
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 26247 0
New Zealand
State/province [1] 26247 0
Otago

Funding & Sponsors
Funding source category [1] 316302 0
Commercial sector/Industry
Name [1] 316302 0
Nova Chem Australasia Pty Ltd
Country [1] 316302 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
Country
New Zealand
Secondary sponsor category [1] 318490 0
None
Name [1] 318490 0
Address [1] 318490 0
Country [1] 318490 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315122 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 315122 0
Ethics committee country [1] 315122 0
New Zealand
Date submitted for ethics approval [1] 315122 0
26/10/2023
Approval date [1] 315122 0
24/11/2023
Ethics approval number [1] 315122 0
2023 FULL 18624

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

Contacts
Principal investigator
Name 133734 0
Dr Noelyn Hung
Address 133734 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 133734 0
New Zealand
Phone 133734 0
+64 21 482 148
Fax 133734 0
Email 133734 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 133735 0
Linda Folland
Address 133735 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 133735 0
New Zealand
Phone 133735 0
+64 3 477 9669
Fax 133735 0
Email 133735 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 133736 0
Dr Tak Hung
Address 133736 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 133736 0
New Zealand
Phone 133736 0
+64 3 477 9669
Fax 133736 0
Email 133736 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.