Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000498392
Ethics application status
Approved
Date submitted
29/03/2017
Date registered
6/04/2017
Date last updated
18/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Single-Centre Open-label Pharmacology Study of Topically Applied MTC896 Gel in Healthy Volunteers.
Scientific title
A Single-Centre Open-label Pharmacology Study of Topically Applied MTC896 Gel in Healthy Volunteers
Secondary ID [1] 291562 0
MCL16001
Universal Trial Number (UTN)
U1111-1194-8117
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne 302656 0
Condition category
Condition code
Skin 302175 302175 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participants will self-administer study drug (MTC896 gel - 1.5% w/w active ingredient) twice daily for 28 days. The study drug will be applied topically to the skin of the postauricular region from a single use tube containing 0.5 mL MCL896 gel in the morning and evening.. Participants will be required to complete a diary recording details of study drug administration.
Intervention code [1] 297623 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301594 0
To evaluate the pharmacology of MTC896 Gel in otherwise healthy participants with oily skin through the comparison of sebaceous gland size after 28 days of treatment, compared with baseline.
Timepoint [1] 301594 0
Skin biopsy collected at baseline and following 28 days of study drug administration.
Primary outcome [2] 301672 0
To evaluate the pharmacology of MTC896 Gel in otherwise healthy participants with oily skin through the comparison of the number of sebaceous glands after 28 days of treatment, compared with baseline.
Timepoint [2] 301672 0
Skin biopsy collected at baseline and following 28 days of study drug administration.
Primary outcome [3] 301673 0
To evaluate the pharmacology of MTC896 Gel in otherwise healthy participants with oily skin through the comparison of sebaceous gland cross sectional area after 28 days of treatment, compared with baseline.
Timepoint [3] 301673 0
Skin biopsy collected at baseline and following 28 days of study drug administration.
Secondary outcome [1] 333240 0
To evaluate the tolerability of topical MTC896 gel.
Timepoint [1] 333240 0
Assessment of local skin reactions based on Extended Bergman and Bowman Scale at baseline and after 14 and 28 days of study drug administration.
Secondary outcome [2] 333241 0
To evaluate the safety of topical MTC896 gel
Timepoint [2] 333241 0
Review of adverse event data at baseline and after 14 and 28 days of study drug administration based on collection of solicited and unsolicited reports from the participant, as collected at each visit. e.g. participant report of discomfort at application site..

Eligibility
Key inclusion criteria
* Generally healthy, non-pregnant females
* Has oily skin, as measured by a Sebumeter at screening (> or = to 150 ug/cm2/h) in the periauricular region).
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnancy
* Skin conditions that would interfere with assessments (e.g. rosacea, acne, dermatitis).
* Recent use of oral retinoids of Vitamin A supplements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is an open-label study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Two analysis populations will be defined:
* Per-Protocol (PP) Population will include all participants who are enrolled and received study medication, completed the study, were at least 80% compliant with study medication, and showed no other serious deviations from the study protocol.
* Safety population will include all participants who are enrolled and received at least one confirmed dose of study medication.
For categorical parameters, the number and percentage of participants in each category will be presented. The denominator for percentage will be based on the number of participants appropriate or the purpose of analysis.
For continuous parameters, descriptive statistics will include n (number of participants), mean, standard deviation (SD), median, minimum, and maximum.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/04/2017
Actual
3/05/2017
Date of last participant enrolment
Anticipated
3/05/2017
Actual
17/05/2017
Date of last data collection
Anticipated
31/05/2017
Actual
12/07/2017
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7745 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 15662 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 296050 0
Commercial sector/Industry
Name [1] 296050 0
Mimetica Pty Ltd
Country [1] 296050 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Mimetica Pty Ltd
Address
Level 19,
HWT Tower
40 City Road
Southbank VIC 3006
Country
Australia
Secondary sponsor category [1] 294941 0
None
Name [1] 294941 0
Address [1] 294941 0
Country [1] 294941 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297307 0
Bellberry Ltd
Ethics committee address [1] 297307 0
129 Glen Osmond Road
Eastwood
South Australia 3063
Ethics committee country [1] 297307 0
Australia
Date submitted for ethics approval [1] 297307 0
01/03/2017
Approval date [1] 297307 0
05/04/2017
Ethics approval number [1] 297307 0

Summary
Brief summary
This study is designed to investigate the pharmacology of MTC896 Gel in otherwise healthy female participants with oily skin. In this study, MTC896 Gel will be applied at 1 concentration, twice daily (bid) for 4 weeks to the postauricular region (behind the ear) a region known to be rich in sebaceous glands. Participants will be required to administer study drug at home, other than when applications coincide with study outpatient visits.

All participants will be required to attend a screening visit, at which skin oilyness will be measured with a Sebumeter (a non-invasive skin probe), If participants are deemed eligible for the study, a small biopsy will be collected from the post auricular region. Study participants will be shown how to administer study drug, and will be discharged with study medication for home dosing. Participants will be asked to record their doses and any symptoms in a diary during the 28 day follow up period.

Participants will be asked to return for an outpatient visit after 14 days, then a final follow up visit at 28 days. At the final follow up visit a second biopsy sample will be collected from the post-auricular region, and sebum (oil) levels will be evaluated with a sebumeter.

It is hoped that the results of this study will provide evidence that MCL16001 is able to reduce skin oiliness, and may therefore be useful in the prevention and treatment of acne.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73654 0
Dr Catherine Reid
Address 73654 0
CMAX Clinical Research Pty Ltd,
Level 5
18a North Terrace
Adelaide SA 5000
Country 73654 0
Australia
Phone 73654 0
+61 8 7088 7900
Fax 73654 0
+61 8 7088 7999
Email 73654 0
cmax@cmax.com.au
Contact person for public queries
Name 73655 0
Michael Thurn
Address 73655 0
Mimetica Pty Ltd
Level 19, HWT Tower
40 City Road
Southbank Victoria 3006
Australia
Country 73655 0
Australia
Phone 73655 0
+61 2 6362 7663
Fax 73655 0
Email 73655 0
m.thurn@mimetica.com.au
Contact person for scientific queries
Name 73656 0
Michael Thurn
Address 73656 0
Mimetica Pty Ltd
Level 19, HWT Tower
40 City Road
Southbank Victoria 3006
Australia
Country 73656 0
Australia
Phone 73656 0
+61 2 6362 7663
Fax 73656 0
Email 73656 0
m.thurn@mimetica.com.au

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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