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Trial registered on ANZCTR


Registration number
ACTRN12620000184976
Ethics application status
Approved
Date submitted
15/01/2020
Date registered
18/02/2020
Date last updated
17/05/2021
Date data sharing statement initially provided
18/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised, Double-Blind, Vehicle-Controlled Study of the Safety and Tolerability of Two Dosage Forms of BTX 1702 in Patients with Papulopustular Rosacea
Scientific title
A Randomised, Double-Blind, Vehicle-Controlled Study of the Safety and Tolerability of Two Dosage Forms of BTX 1702 in Patients with Papulopustular Rosacea
Secondary ID [1] 300135 0
BTX.1702.110
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Papulopustular Rosacea 315667 0
Condition category
Condition code
Skin 313958 313958 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BTX 1702 5% (w/w) Solution or BTX 1702 5% (w/w) Gel.
Applied twice per day for 42 days. 3 mL of study drug applied to the entire face using a applicator swab. Treatment is assigned via randomization code.
All patients will be required to maintain a diary documenting each application of study drug. Patients will return the study drug bottles and swabs (used and unused) at each visit so that the clinical site staff can ensure patient compliance with dosing.
Intervention code [1] 316410 0
Treatment: Drugs
Comparator / control treatment
BTX 1702 Vehicle Solution or BTX 1702 Vehicle Gel
Control group
Placebo

Outcomes
Primary outcome [1] 322359 0
The safety and tolerability of BTX 1702 5% (w/w) Solution, BTX 1702 5% (w/w) Gel, BTX 1702 Vehicle Solution or BTX 1702 Vehicle Gel following 42 days of twice daily applications in patients with papulopustular rosacea.
The safety outcome measures to be assessed are:
• Reported adverse events (AEs) including treatment-emergent adverse events (TEAE);
• Changes in clinical labs including complete blood count (CBC), chemistry, and urinalysis;
• Cutaneous tolerability (erythema, scaling, dryness, pruritis, and burning/stinging);
• Patient diary reports of burning/stinging and pruritis;
• Urine pregnancy testing for women of child-bearing potential (WOCBP); and,
• Blood samples to assess the plasma levels of study drug taken pre-dose.
Timepoint [1] 322359 0
• Reported adverse events from Screening to Day 43;
• Changes in clinical labs between Baseline and Day 43;
• Cutaneous tolerability at Baseline and Days 8, 22 and 43;
• Burning/stinging and pruritis at Baseline and Days 8, 22 and 43;
• Pregnancy at Screening, Baseline and Day 43; and,
• Plasma levels of study drug at Baseline and Days 8, 22 and 43.
Secondary outcome [1] 378210 0
Absolute change in inflammatory lesion counts.
Timepoint [1] 378210 0
Baseline to Days 8, 22 and 43.
Secondary outcome [2] 378211 0
Percent change in inflammatory lesion counts.
Timepoint [2] 378211 0
Baseline to Days 8, 22 and 43.
Secondary outcome [3] 379398 0
Proportion of patients with treatment success defined as clear or almost clear active inflammatory papules / pustules assessed by Investigator’s Global Assessment.
Timepoint [3] 379398 0
Baseline to Days 22 and 43.
Secondary outcome [4] 379399 0
Proportion of patients with an improvement (greater than or equal to 2 grades) of active inflammatory papules / pustules assessed by Investigator’s Global Assessment.
Timepoint [4] 379399 0
Baseline to Days 22 and 43.
Secondary outcome [5] 379400 0
Changes in erythema severity using Clinician’s Erythema Assessment (CEA) scale.
Timepoint [5] 379400 0
Baseline to Days 8, 22 and 43.
Secondary outcome [6] 379401 0
Imaging changes using photography.
Timepoint [6] 379401 0
Baseline to Day 8, Day 22 and Day 43.
Secondary outcome [7] 379402 0
Rosacea symptoms summarised using Patient Reported Outcome (PRO) questionnaire.
Timepoint [7] 379402 0
Baseline to Day 43.

Eligibility
Key inclusion criteria
1. Patient has a diagnosis at Screening and Baseline of papulopustular rosacea of the face defined as:
a. 15 to 75 (inclusive) inflammatory lesions (papules/pustules) on the face;
b. An Investigator’s Global Assessment (IGA) score for rosacea severity of 3 or 4 (moderate or severe), assessed on the face.
c. Clinician’s Erythema Assessment (CEA) score of 3 or 4 (moderate or severe) assessed on the face.
d. Absence of comedones.
e. Independent reviewer confirmation of rosacea patients with erythema and papules/pustules of the face.
2. Patient has <2 nodular lesions (>5 mm in diameter).
3. Absence or presence of telangiectasia.
4. Patient agrees to not use marijuana or cannabidiol (CBD) products throughout the study.
5. A negative urine pregnancy test result for all women of child-bearing potential at the Screening Visit and Baseline Visit.
6. Sexually active women must agree to use contraception throughout the study and for 30 days after last study drug application.
7. Male patients must refrain from sperm donation during the course of the study and until 90 days post study drug administration.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient with a history of known or suspected intolerance to the drug product excipients (hexamethyldisiloxane, dimethicone, polypropylene glycol (PPG) 15 stearyl ether) and Silicone Gum 1515.
2. Patient has used any marijuana products, via any route, within 4 weeks prior to the Screening Visit. A positive urine drug screen for tetrahydrocannabinol (THC) will exclude the patient.
3. Patient has any significant active infection.
4. Patient has known human immunodeficiency viruses (HIV) infection or hepatitis B or C.
5. Patient has initiated a hormonal method contraception within 3 months of Baseline or plans to discontinue during the course of the study, or changed product within 3 months of Baseline or plans to change during the course of the study.
6. Patient has used topical acne or rosacea treatments within 4 weeks of Baseline.
7. Patient has used systemic retinoids within 90 days of Baseline.
8. Patient has used topical or systemic antibiotics within 4 weeks of Baseline.
9. Patient is using or plans to use a clinically significant concomitant/prohibited drug therapy, treatment or procedure..
10. Patient has used (>14 days) topical or systemic anti-inflammatories in the 4 weeks prior to Baseline.
11. Patient has used topical or systemic corticosteroids 4 weeks prior to Baseline.
12. Patient has used vasodilating agents (eg. anti-hypertensives, erectile dysfunction drugs, nitroglycerin) 6 weeks prior to Baseline.
13. Patient has used alpha-adrenergic receptor-blocking agents 6 weeks or alpha-adrenergic agonists 4 weeks prior to Baseline.
14. Patient has ocular rosacea and/or blepharitis/meibomianitis and require treatment by an ophthalmologist during the course of the study.
15. Patient has sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality that would result in the inability to perform study assessments.
16. Patient has an active or potentially recurring skin conditions(s) other than rosacea that will interfere with the assessment of rosacea.
17. Patient has clinically significant or severe allergies that in the investigator’s opinion would interfere with participation in the study.
18. Patient has used systemic or other immunosuppressive medications within 4 weeks of the Baseline Visit (inhaled corticosteroid less than or equal to 1000 µg daily dose is acceptable).
19. Patient has used phototherapy 14 days prior to Baseline or has had excessive sun exposure with intent to sunbathe or tan or use artificial tanning agents.
20. Patient has other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, acne or atopic dermatitis.

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (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
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The selected sample size is based on having appropriate sensitivity to observe a safety signal. The sample size of approximately 120 Patients (60 active: 60 vehicle) with papulopustular rosacea is adequate to determine a preliminary assessment of safety.
All safety summaries will be conducted on patients who receive at least one application of study drug based on the study drug they received, regardless of the treatment to which they were randomised.
Exploratory analysis of BTX 1702 5% (w/w) Solution’s or Gel’s effect on rosacea will be conducted on all data acquired. Analysis will be based on the group to which the patient was randomised, regardless of the treatment they received

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study was not commenced.
Date of first participant enrolment
Anticipated
1/07/2020
Actual
Date of last participant enrolment
Anticipated
30/10/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment outside Australia
Country [1] 22198 0
New Zealand
State/province [1] 22198 0

Funding & Sponsors
Funding source category [1] 304572 0
Commercial sector/Industry
Name [1] 304572 0
Botanix Pharmaceuticals Ltd
Country [1] 304572 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Botanix Pharmaceuticals Ltd
Address
Level 1, 50 Angove Street, North Perth, Western Australia 6005
Country
Australia
Secondary sponsor category [1] 304868 0
None
Name [1] 304868 0
Address [1] 304868 0
Country [1] 304868 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304999 0
Bellberry HREC
Ethics committee address [1] 304999 0
Ethics committee country [1] 304999 0
Australia
Date submitted for ethics approval [1] 304999 0
16/12/2019
Approval date [1] 304999 0
24/12/2019
Ethics approval number [1] 304999 0
2019-09-829
Ethics committee name [2] 305106 0
Central HDEC
Ethics committee address [2] 305106 0
Ethics committee country [2] 305106 0
New Zealand
Date submitted for ethics approval [2] 305106 0
10/02/2020
Approval date [2] 305106 0
Ethics approval number [2] 305106 0

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

Contacts
Principal investigator
Name 98914 0
Dr Michael Benson
Address 98914 0
Captain Stirling Medical Centre,
92 Stirling Highway,
Nedlands,
WA 6009
Country 98914 0
Australia
Phone 98914 0
+61 8 9386 1858
Fax 98914 0
Email 98914 0
[email protected]
Contact person for public queries
Name 98915 0
Michael Thurn
Address 98915 0
Botanix Pharmaceuticals Ltd,
Level 1, 50 Angove Street,
North Perth,
WA 6005
Country 98915 0
Australia
Phone 98915 0
+61 403 192 615
Fax 98915 0
Email 98915 0
[email protected]
Contact person for scientific queries
Name 98916 0
Michael Thurn
Address 98916 0
Botanix Pharmaceuticals Ltd,
Level 1, 50 Angove Street,
North Perth,
WA 6005
Country 98916 0
Australia
Phone 98916 0
+61 403 192 615
Fax 98916 0
Email 98916 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


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.