Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000887673
Ethics application status
Approved
Date submitted
8/08/2023
Date registered
18/08/2023
Date last updated
10/12/2023
Date data sharing statement initially provided
18/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of a branded (marketed) formulation betamethasone dipropionate called Diprosone® cream applied to the skin in healthy male and female volunteers to determine the appropriate dose duration (ED50) for use in a pivotal in vivo bioequivalence study.
Scientific title
A pilot dose duration-response study using a branded (marketed) formulation betamethasone dipropionate called Diprosone® cream to determine the appropriate dose duration (ED50) for use in a pivotal in vivo bioequivalence study and using participants who demonstrate adequate vasoconstriction to topical steroids.
Secondary ID [1] 310328 0
None
Universal Trial Number (UTN)
U1111-1295-0739
Trial acronym
.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diprosone cream is indicated for the topical treatment of eczema and psoriasis in children and adults. 331058 0
Condition category
Condition code
Skin 327849 327849 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 Diprosone cream (Betamethasone dipropionate 0.5 mg/g (0.05% w/w)) at various dose durations. The intervention for this trial is the Reference Listed Drug (RLD) of Diprosone cream (Betamethasone dipropionate 0.5 mg/g (0.05% w/w)).

Subjects will be healthy subjects who have shown a vasoconstriction response to a single dose of Diprosone cream. All applications, measurements and assessments will be carried out at the Zenith Clinical Site where all participants will be confined and monitored for the duration of the study i.e. a 2 day period.

There will be 12 sites in total (6 on each arm) where 4 sites will be treated with the Diprosone cream and 2 will be untreated control sites. The 8 treated sites (4 on each arm) will have 10 mg of Diprosone cream applied at various dose-durations at 6, 4, 2, 1.5, 1, 0.75, 0.5 and 0.25 hours prior to Diprosone cream removal. The Diprosone 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] 326729 0
Treatment: Other
Intervention code [2] 326730 0
Treatment: Drugs
Comparator / control treatment
No treatment on two untreated sites
Control group
Active

Outcomes
Primary outcome [1] 335693 0
To determine the ED50 parameter of Diprosone cream (Betamethasone dipropionate 0.5 mg/g (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] 335693 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 ointment removal
Primary outcome [2] 335694 0
To determine the D1 parameter of Diprosone cream (Betamethasone dipropionate 0.5 mg/g (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] 335694 0
Fatty Ointment 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 ointment removal
Secondary outcome [1] 425219 0
To determine the D2 parameter of Diprosone cream (Betamethasone dipropionate 0.5 mg/g (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] 425219 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 ointment removal

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
Demonstrates adequate vasoconstriction to the RLD at Screening for Response
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)
Each participant will be identified by a 3 digit screening number and a 2 digit subject number. The screening number will be issued once the participant has given written consent to participate in the study and the two digit study number (randomisation number) after acceptance into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed using a randomisation table created by computer software (i.e. computerized sequence generation).

Treatment sites will be randomly allocated for each participant.
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 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/08/2023
Actual
31/08/2023
Date of last participant enrolment
Anticipated
Actual
31/08/2023
Date of last data collection
Anticipated
Actual
1/09/2023
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 25696 0
New Zealand
State/province [1] 25696 0
Otago

Funding & Sponsors
Funding source category [1] 314533 0
Commercial sector/Industry
Name [1] 314533 0
Nova Chem Australasia Pty Ltd
Country [1] 314533 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] 316486 0
None
Name [1] 316486 0
Address [1] 316486 0
Country [1] 316486 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313575 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 313575 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 313575 0
New Zealand
Date submitted for ethics approval [1] 313575 0
11/07/2023
Approval date [1] 313575 0
16/08/2023
Ethics approval number [1] 313575 0
2023 EXP 18329

Summary
Brief summary
To determine the dose duration-response using Diprosone cream in healthy volunteers who demonstrate adequate vasoconstriction to topical steroids.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128606 0
Dr Noelyn Hung
Address 128606 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin 9016
Country 128606 0
New Zealand
Phone 128606 0
+64 21 482 148
Fax 128606 0
+64 3 477 9605
Email 128606 0
[email protected]
Contact person for public queries
Name 128607 0
Linda Folland
Address 128607 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin 9016
Country 128607 0
New Zealand
Phone 128607 0
+64 3 477 9669
Fax 128607 0
+64 3 477 9605
Email 128607 0
[email protected]
Contact person for scientific queries
Name 128608 0
Tak Hung
Address 128608 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin 9016
Country 128608 0
New Zealand
Phone 128608 0
+64 3 477 9669
Fax 128608 0
+64 3 477 9605
Email 128608 0
[email protected]

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.