Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001802291
Ethics application status
Approved
Date submitted
30/10/2018
Date registered
5/11/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
5/11/2018
Date results information initially provided
12/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vehicle and Comparator-Controlled, Evaluator-blinded Trial
to Evaluate the Safety and Anti-Psoriatic Efficacy of Topical
Formulations of BTX 1308 in Subjects with Psoriasis Vulgaris
in a Psoriasis Plaque Test
Scientific title
Vehicle and Comparator-Controlled, Evaluator-blinded Trial
to Evaluate the Safety and Anti-Psoriatic Efficacy of Topical
Formulations of BTX 1308 in Subjects with Psoriasis Vulgaris
in a Psoriasis Plaque Test
Secondary ID [1] 296468 0
None
Universal Trial Number (UTN)
U1111-1222-9389
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis vulgaris 310254 0
Condition category
Condition code
Skin 308978 308978 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each subject will have four (4) treatments applied simultaneously by study personnel. Topical occlusive applications of approximately 150 µL per test field (1.1 cm2) will be done once daily during a 19-day study period, except on Days 7, 14, and 19, for a total of 16 treatments
Two formulations of BTX 1308 with the active ingredient cannabidiol (CBD) will be applied:
• BTX 1308-1 5%
• BTX 1308-3 20%
Intervention code [1] 312792 0
Treatment: Drugs
Comparator / control treatment
BTX 1308 Vehicle with no CBD
Betamethasone valerate (Betnovate® 0.1% Ointment)
Control group
Placebo

Outcomes
Primary outcome [1] 307945 0
Measurement of the thickness (µm) of the Echo Poor Band (EPB) of the psoriatic inflammatory infiltrate using 22-MHz sonography.
Timepoint [1] 307945 0
The primary endpoint is the change from Baseline to Day 19 in psoriatic infiltrate thickness.
Secondary outcome [1] 353432 0
Percent change from Baseline to Day 8, 12 and 19 in psoriatic infiltrate thickness, as measured by the Echo Poor Band (EPB) of the psoriatic inflammatory infiltrate using 22-MHz sonography
Timepoint [1] 353432 0
Percent change from Baseline to Day 8, 12 and 19 in psoriatic infiltrate thickness
Secondary outcome [2] 353539 0
Change from Baseline to Day 8 and 12 in psoriatic infiltrate thickness
Timepoint [2] 353539 0
Change from Baseline to Day 8 and 12
Secondary outcome [3] 353540 0
Change from Baseline to Day 8, 12 and 19 of the AUC (area under the curve) of psoriatic infiltrate thickness
Timepoint [3] 353540 0
Change from Baseline to Day 8, 12 and 19
Secondary outcome [4] 353541 0
Evaluation of the anti-psoriatic efficacy by clinical assessment
using a 5-point scale at Day 8, 12 and 19
Timepoint [4] 353541 0
Day 8, 12 and 19
Secondary outcome [5] 353542 0
Clinical assessment of erythema (abnormal redness of the skin; absolute score scale) using a 5-point scale at Day 8, 12 and 19. This is a safety and cutaneous tolerability assessment.
Timepoint [5] 353542 0
Day 8, 12 and 19

Eligibility
Key inclusion criteria
To be included in the study, subjects must meet the following inclusion criteria.
1. Subject (or legal guardian) has the ability and willingness to sign a written informed
consent.
2. Subject is of either gender and 18 years or older
3. Subject is in good general health without clinically significant haematological, cardiac,
respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as
determined by the investigator.
4. Subject has psoriasis vulgaris in a chronic stable phase and mild to moderate plaque(s) with
up to 3 comparable psoriatic plaque(s) sufficient for 4 treatment fields.
5. Subject has the treatment field lesion(s) located on the trunk or extremities (excluding
palms/soles); psoriatic lesions on the knees or elbows (joints) are not to be used as
treatment fields.
6. Identified treatment fields should have a comparable EPB thickness of the psoriatic
infiltrate of at least 200 µm. This will be measured on Day 1.
7. Subject´s physical examination of the skin must be without disease findings other than
psoriasis vulgaris unless the investigator considers an abnormality to be irrelevant to the
outcome of the clinical trial.
8. A negative urine pregnancy test (UPT) result for all women if childbearing potential (WOCBP) at the Screening Visit and Baseline Visit, if
applicable. A WOCBP is one who is not permanently sterilised or is not postmenopausal.
Postmenopausal is defined as 24 months with no menses without an alternative medical
cause.
9. Sexually active WOCBP must agree to use the following throughout the study and for 30
days after last study drug application:
a. One of these highly effective contraception methods
i. Intrauterine device (IUD); hormonal (injections, implants, transdermal
patch, vaginal ring; tubal ligation; partner vasectomy, OR
b. Oral contraceptives WITH a barrier method (listed below), OR
c. Two barrier forms of contraception (listed below)
i. Male or female condom; diaphragm; cervical cap.
10. Subject is able and willing to complete the study and to comply with all study instructions
and attend the necessary visits.
11. Male subjects and their partners must agree and commit to use a barrier method of
contraception during the study and for 90 days after last study drug application.
12. Male subjects must refrain from sperm donation during the study treatment period until 90
days after final study drug administration
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If a subject meets any of the following exclusion criteria, they may not participate in the study.
1. Subject has other skin disease noted on physical examination that is considered by the
investigator to be relevant to the outcome of the trial.
2. Subject has acute guttate psoriasis, erythrodermatic psoriasis or pustular psoriasis.
3. Subject has used any topical anti-psoriatics on plaques potentially to be treated in this trial
(including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol
and tar, except for salicylic acid and except for treatment on the face, ears and scalp) in the
4 weeks before the Baseline Visit.
4. Subject has used systemic treatment with anti-psoriatics e.g., corticosteroids, cytostatics,
or retinoids in the three months before the Baseline Visit.
5. Subject has used biologicals (e.g., ustekinumab, secukinumab, ixekizumab, guselkumab,
adalimumab, infliximab and etanercept) within six months before the Baseline Visit.
6. Subject has used UV-therapy within four weeks before the Baseline Visit.
7. Subject has had treatment with any concomitant medication that may affect and provoke
or aggravate psoriasis, e.g., antimalarial drugs, lithium, beta-blockers or ACE inhibitors
unless on a stable dose for 3 months before the Baseline Visit.
8. Subject has known allergic reactions, irritations or sensitivity to the active ingredients or
other components of the study drugs.
9. Subject has contraindications according to summary of product characteristics for
betamethasone valerate, the active comparator.
10. Subject is receiving treatment with anticoagulant drugs (biopsy group only), which in the
opinion of the investigator will be of concern for the biopsy procedure.
11. Subject has HIV or active virus hepatitis (only applicable for subjects consenting to biopsy
sampling).
12. Subject has positive pregnancy test or is nursing.
13. Subject has a history or symptoms of a clinically significant illness in the 4 weeks before
first treatment and during the trial that in the opinion of the investigator may place the
subject at risk by trial participation or influence the outcome of the trial.
14. Subject has blood pressure above 160 mm Hg (systolic) and/or 95 mm Hg (diastolic) at the
Screening Visit.
15. Subject is participating or has participated in the treatment phase of another clinical trial
within the last 4 weeks prior to the Baseline Visit.
16. Subject has a clinically relevant history or currently suffering from any disease or condition
that, in the opinion of the investigator, may affect the evaluation of the study product or
place the subject at undue risk. This may include respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, hematological,
lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary,
immunological, or connective tissue diseases or disorders.
17. Any other reason that would make the subject, in the opinion of the investigator or sponsor,
unsuitable for the 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/10/2018
Date of last participant enrolment
Anticipated
16/01/2019
Actual
6/02/2019
Date of last data collection
Anticipated
24/02/2019
Actual
24/02/2019
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 301062 0
Commercial sector/Industry
Name [1] 301062 0
Botanix Pharmaceuticals Limited
Country [1] 301062 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Botanix Pharmaceuticals Limited
Address
68 Aberdeen Street
Northbridge WA 6003
Australia
Country
Australia
Secondary sponsor category [1] 300672 0
None
Name [1] 300672 0
Address [1] 300672 0
Country [1] 300672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301816 0
Bellberry Human Research Ethics Committee E (EC00450)
Ethics committee address [1] 301816 0
129 Glen Osmond Road
Eastwood
South Australia 5063
Ethics committee country [1] 301816 0
Australia
Date submitted for ethics approval [1] 301816 0
Approval date [1] 301816 0
05/10/2018
Ethics approval number [1] 301816 0

Summary
Brief summary
BTX 1308 contains the active pharmaceutical ingredient, cannabidiol in a topical liquid formulation, and is being developed for the treatment of psoriasis vulgaris by Botanix Pharmaceuticals Limited. CBD is a member of a broader family of compounds known as cannabinoids, a class of compounds originally
derived from the cannabis sativa plant. CBD is chemically synthesized under Good Manufacture Practices (GMP) for use in this study.The objective of this study is to assess preliminary safety, tolerability, and activity of various formulations and concentrations of BTX 1308 in subjects with mild to moderate, stable, plaque-type psoriasis.
This will be a single-center, vehicle and comparator-controlled, evaluator-blinded study in volunteers aged 18 years and over.
Participants will receive 4 treatments, across up to 3 comparable psoriasis plaques.
BTX 1308 – 1 5%
BTX 1308 – 3 20%
BTX 1308 Vehicle
Approved psoriasis product – Betnovate® (betamethasone valerate) Ointment 0.1%

Safety and cutaneous tolerability will be assessed by the collection and review of AEs and application site review, laboratory parameters throughout the duration of the trial.
Efficacy assessments will include measurement of the thickness of the psoriatic inflammatory infiltrate using sonography.
Photography of the treated area will be conducted for all participants.
Participants will remain in follow up until 19 days following the first application of investigational product.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88210 0
Dr Catherine Reid
Address 88210 0
CMAX Clinical Research Pty Ltd
Level 5, 18a North Terrace
Adelaide SA 5000
Country 88210 0
Australia
Phone 88210 0
+61 8 7088 7900
Fax 88210 0
Email 88210 0
cmax@cmax.com.au
Contact person for public queries
Name 88211 0
Dr Michael Thurn
Address 88211 0
Botanix Pharmaceuticals Ltd
68 Aberdeen Street
Northbridge WA 6003
Australia
Country 88211 0
Australia
Phone 88211 0
+61 (0) 403 192 615
Fax 88211 0
Email 88211 0
mthurn@botanixpharma.com
Contact person for scientific queries
Name 88212 0
Dr Michael Thurn
Address 88212 0
Botanix Pharmaceuticals Ltd
68 Aberdeen Street
Northbridge WA 6003
Australia
Country 88212 0
Australia
Phone 88212 0
+61 (0) 403 192 615
Fax 88212 0
Email 88212 0
mthurn@botanixpharma.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary