Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001744145
Ethics application status
Approved
Date submitted
2/12/2019
Date registered
9/12/2019
Date last updated
22/11/2022
Date data sharing statement initially provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
3% Kanuka Oil Serum for the Topical Treatment of Acne
Scientific title
Feasibility Study of 3% Kanuka Oil Serum vs Vehicle Control for the Topical Treatment of Facial Acne Vulgaris
Secondary ID [1] 299975 0
None
Universal Trial Number (UTN)
U1111-1215-3276
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne Vulgaris 315433 0
Condition category
Condition code
Skin 313735 313735 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3% Kanuka Oil Serum
Applied topically, twice daily, for 12 weeks.
Participants are recommended to apply the treatment liberally to the affected areas.
A weekly participant diary will be used to monitor adherence.
Intervention code [1] 316235 0
Treatment: Drugs
Comparator / control treatment
Vehicle Control
The same serum as the active intervention without the kanuka oil.
Water, Prunus amygdalus dulcis (almond) oil, Glycerine, Cetearyl alcohol, Cetearyl glucoside, Sorbitan olivate, Xanthan gum, Benzyl alcohol, Dehydroacteic acid

Applied topically, twice daily, for 12 weeks.
Participants are recommended to apply the treatment liberally to the affected areas.
A weekly participant diary will be used to monitor adherence.
Control group
Placebo

Outcomes
Primary outcome [1] 322151 0
Difference in DLQI scores
Timepoint [1] 322151 0
Week 12 post baseline
Secondary outcome [1] 377503 0
Difference in CADI scores
Timepoint [1] 377503 0
Week 12 post baseline
Secondary outcome [2] 377504 0
Mean total lesion count

Total facial lesions will be counted during a clinical examination, occurring at each visit.
Timepoint [2] 377504 0
Week Six post baseline and Week 12 post baseline
Secondary outcome [3] 377505 0
Mean inflammatory lesion count

Inflammatory facial lesions will be counted during a clinical examination, occurring at each visit.
Timepoint [3] 377505 0
Week Six post baseline and Week 12 post baseline
Secondary outcome [4] 377506 0
Mean IGA score
Timepoint [4] 377506 0
Week Six post baseline and Week 12 post baseline
Secondary outcome [5] 377507 0
Proportion of participants with an IGA score of 0 ("clear") or 1 ("almost clear")
Timepoint [5] 377507 0
Week 12 post baseline
Secondary outcome [6] 377508 0
Proportion of participants with a greater than or equal to 2 IGA grade reduction
Timepoint [6] 377508 0
Week 12 post baseline
Secondary outcome [7] 377509 0
Proportions of withdrawals for worsening acne between groups.

(At the point of withdrawal participants will be asked if a reason they are withdrawing is worsening of their acne The proportions of participants that respond in the affirmative will be compared between groups)
Timepoint [7] 377509 0
Week 12 post baseline
Secondary outcome [8] 377510 0
Patient acceptability of treatment as assessed by TSQM-2. Acceptability will be broken down as effectiveness, side effects, convenience and global satisfaction.
Timepoint [8] 377510 0
Week 12 post baseline
Secondary outcome [9] 377511 0
Proportions of related and probably related cutaneous and systemic adverse events between treatment groups. eg worsening acne, local inflammation, or allergic cutaneous reactions. (Adverse events will be assessed for relation to the study treatment by they study doctor. All adverse events deemed related or probably related will be included in the proportions.)
Timepoint [9] 377511 0
Week 12 post baseline
Secondary outcome [10] 377512 0
Comparison of blinded, objective face to face pharmacist IGA score and remote dermatologist IGA score
Timepoint [10] 377512 0
Week 12 post baseline
Secondary outcome [11] 377513 0
Comparison of blinded, objective face to face pharmacist lesion counts and remote dermatologist lesion counts
Timepoint [11] 377513 0
Week 12 post baseline
Secondary outcome [12] 397494 0
Proportions of treatment escalation between groups as assessed by participant reported concomitant medication use.
Timepoint [12] 397494 0
Week 12 post baseline

Eligibility
Key inclusion criteria
• Participant has the ability and willingness to sign a written informed consent using a digital signature or paper form if back up is required.
• Participant is aged between 18 and 50 years of age, inclusive.
• Participant reported, Physician diagnosis of acne vulgaris.
• A minimum of 10 inflammatory/non-inflammatory acne lesions on the face.
• A minimum CADI score of greater than or equal to 1.
• A minimum IGA score of greater than or equal to 2.
• Participant is willing to stop current acne treatments.
• Participant is willing to replace their facewash/cleanser with a facial cleanser (Cetaphil) as supplied at enrolment.
• Participant is able and willing to attend the follow up visits during the visit windows.
• Participant is able and willing to complete the study and to comply with all study instructions.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severity of acne requiring any systemic therapy including isotretinoin, systemic antibiotics, or hormonal therapies.
- Use of the following anti acne treatments: topical acne medication in the last two weeks; systemic antibiotics in the last four weeks; systemic retinoids in the last 12 weeks.
- Participant has a current requirement for hormonal therapy, unless they have been on a stable dose for eight weeks or longer.
- Participant has any inflammatory skin condition of the face other than acne vulgaris.
- Participant has an active skin or systemic infection
- Participant with history of known or suspected allergy or intolerance to Kunzea Robusta (Kanuka) Oil, Glycerine, Simmondsia Chinensis (Jojoba) Oil, Sclerotium Gum, Benzyl alcohol or Dehydroacetic Acid.
- Participant has facial hair that would interfere with acne assessment.
- Participant wears cosmetics that would interfere with acne assessment.
- Participant is pregnant or planning to become pregnant during the study.
- Participation in a clinical trial involving an investigational product during the last three months.
- Any other condition which, at the investigators’ discretion, it is believed may present a safety risk or impact upon the ability of the participant to complete 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)
Randomisation will be done in the study database using the inbuilt randomisation module. Investigators will not have access to the randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician generated block randomisation schedule, using a block size of six
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
No power calculation for sample size is required for this proof of concept, feasibility study, however 15 participants per arm will provide sufficient estimation of SDs to inform a potential full RCT.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2021
Actual
3/03/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
15/03/2022
Date of last data collection
Anticipated
31/03/2022
Actual
21/06/2022
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 22158 0
New Zealand
State/province [1] 22158 0

Funding & Sponsors
Funding source category [1] 304433 0
Other
Name [1] 304433 0
Hikurangi Bioactives Limited Partnership
Country [1] 304433 0
New Zealand
Primary sponsor type
Other
Name
Hikurangi Bioactives Limited Partnership
Address
6434 Waiapu Road, RD 1, Ruatoria 4081
Country
New Zealand
Secondary sponsor category [1] 304692 0
None
Name [1] 304692 0
Address [1] 304692 0
Country [1] 304692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304868 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 304868 0
Ethics committee country [1] 304868 0
New Zealand
Date submitted for ethics approval [1] 304868 0
13/06/2019
Approval date [1] 304868 0
29/10/2019
Ethics approval number [1] 304868 0
19/CEN/103

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

Contacts
Principal investigator
Name 98466 0
Dr Alex Semprini
Address 98466 0
Medical Research Institute of New Zealand (MRINZ)
Level 7, CSB Building Wellington Hospital Riddiford St, Newtown Wellington 6021 New Zealand
Country 98466 0
New Zealand
Phone 98466 0
+64 4 805 0260
Fax 98466 0
Email 98466 0
[email protected]
Contact person for public queries
Name 98467 0
Nick Shortt
Address 98467 0
Medical Research Institute of New Zealand (MRINZ)
Level 7, CSB Building Wellington Hospital Riddiford St, Newtown Wellington 6021 New Zealand
Country 98467 0
New Zealand
Phone 98467 0
+64 4 805 0236
Fax 98467 0
Email 98467 0
[email protected]
Contact person for scientific queries
Name 98468 0
Nick Shortt
Address 98468 0
Medical Research Institute of New Zealand (MRINZ)
Level 7, CSB Building Wellington Hospital Riddiford St, Newtown Wellington 6021 New Zealand
Country 98468 0
New Zealand
Phone 98468 0
+64 4 805 0236
Fax 98468 0
Email 98468 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
This has yet to be decided


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.