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Trial registered on ANZCTR


Trial ID
ACTRN12614001014640
Ethics application status
Approved
Date submitted
11/09/2014
Date registered
22/09/2014
Date last updated
22/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kunzea oil for the management of mild to moderate psoriasis (a common, chronic, relapsing, immune-mediated skin disease: a pilot randomised controlled trial.
Scientific title
Safety and efficacy of kunzea oil-containing formulations for the management of psoriasis, a pilot, randomised, controlled trial.
Secondary ID [1] 285320 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis of the body and scalp 293035 0
Condition category
Condition code
Skin 293305 293305 0 0
Dermatological conditions
Alternative and Complementary Medicine 293306 293306 0 0
Other alternative and complementary medicine
Inflammatory and Immune System 293307 293307 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A [test] received topical test treatment with kunzea oil (20% in an ointment base or scalp lotion, twice daily), and group B [control] applied control medication (twice daily) for 8 weeks.

The control formulation contained the test formulation without the kunzea oil component. Both trialled medications contained 3% salicylic acid (keratolytic agent), which is recommended as a scale lifter, along with liquor carbonis detergens (5% LCD; used instead of crude coal tar which has an unpleasant odour and stains), for the management of psoriasis.

kunzea oil (strength20% in an emollient ointment base or scalp lotion; steam distilled and commercially produced in Tasmania from the bush plant Kunzea ambigua). The type of intervention administered to the study cohort was based on the nature of psoriasis (e.g. scalp psoriasis versus generalised body psoriasis, and if a recruited patient had both forms of psoriasis, both types of trial medications were administered).

Patients were instructed to apply the medication twice daily, once in the morning and once at night, to all psoriatic lesional areas without occlusion for 8 weeks or until cleared. Subjects were advised not to use the medications just before having a bath, a shower or going swimming. Subjects were to apply the study medications (sparingly) by massaging gently on to the affected areas. The maximum application rate was 100 g of ointment and/or 100 ml of scalp lotion per week.

Compliance: Compliance to the treatment protocol was encouraged the use of patient diary. Furthermore, the research assistant reminded the subjects the importance of adhering to the treatment protocol at each of their follow-up visits to the clinical investigator’s office.
Intervention code [1] 290233 0
Treatment: Drugs
Comparator / control treatment
Control medications contained 3% salicylic acid (keratolytic agent), which is recommended as a scale lifter, along with liquor carbonis detergens (5%, LCD; used instead of crude coal tar which has an unpleasant odour and stains), for the management of psoriasis. Patients were given instructions to apply the medication/s twice daily for 8 weeks or until cleared.
Control group
Active

Outcomes
Primary outcome [1] 293144 0
The severity of the disease was measured using the Psoriasis Area and Severity Index (PASI), reported previously. Treatment efficacy was evaluated by assessing the PASI score before and after 8 weeks of treatment. The mean change in score (delta PASI) was the primary outcome measure of the trial.

Reference: Fredriksson T, Pettersson U. Severe psoriasis–oral therapy with a new retinoid. Dermatology 1978;157:238-244.
Timepoint [1] 293144 0
Timepoint: At baseline and 8 weeks after randomisation
Secondary outcome [1] 310442 0
The secondary outcome (pruritus) was evaluated at each visit using a visual analogue scale (VAS) score on a 0–4 point scale, with 0 as the absence and 4 as the maximum degree of pruritus. The sum of the score based on the four body regions (head, upper limbs, trunk, and lower limbs) constituted a total between 0 and 16.


Reference
Kanzler M, Gorsulowsky D. Efficacy of topical 5% liquor carbonis detergens vs. its emollient base in the treatment of psoriasis. British Journal of Dermatology 1993;129:310-314.

Timepoint [1] 310442 0
Timepoint:At baseline and 8 weeks after randomisation

Eligibility
Key inclusion criteria
Entry criteria required a clinical diagnosis of psoriasis involving greater than or equal to 10% of the body surface.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The main exclusion criteria were current diagnosis of unstable psoriasis, atopic dermatitis and other skin conditions (e.g. seborrhoeic dermatitis, contact dermatitis, cutaneous mycosis, presence of pigmentation, extensive scarring, pigmented lesion) confounding psoriasis assessment, pregnancy, breast-feeding, and use of medications that are known to exacerbate the course of psoriasis (lithium, beta adrenergic blocking agents, antimalarial drugs).
Subjects with flexural and pustular psoriasis were not considered because of their rarity and potential treatment difficulties with the trial medications. All patients had a 6-week washout period for systemic therapy (including phototherapy) and 2 weeks for topical psoriatic treatment before receiving the study drugs.

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)
Patients were allocated into the test or control group, using a computer-generated randomisation schedule.
Trial formulations were prepared in the compounding pharmaceutical laboratory in the School of Pharmacy, University of Tasmania, under the supervision of a registered pharmacist. Pharmaceutical grade (USP) excipient vanillin (Sigma-Aldrich, Australia; 1% w/w or w/v) was added into both formulations to mask the characteristic odour of kunzea oil, to ensure effective blinding of subjects to both control and test formulations (ointment and/or scalp lotion). All trial medications had a 28-day expiry period. Medications were packed in identical containers with the code kept secure by a staff member who was not part of the research team. When patients entered into the trial (after eligibility assessment and wash-out period), the clinical investigator’s office contacted the university staff to send the medications (via express registered post) directly to the patients. The same method was followed for the additional supply of medications to study subjects. This enabled the clinical investigator (performing assessments) and other study personnel to be blinded throughout the study period.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once informed written consent had been obtained, the
inclusion/exclusion criteria and baseline assessments have been satisfied /completed, the participants were randomly allocated into one of two groups (test or control) using a computer-generated randomisation schedule.

Randomisation was provided by the study Sponsor, using an
independent statistician.
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
Randomised, controlled
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample Size: The study used a randomised, active-controlled, double-blind design. Power calculations were based on relevant, related published articles. Sample size was estimated using a power index of 7.9 (P=0.05, beta=0.20). A difference of 1 standard deviation between test and control Delta PASI, would have resulted in a statistically significant finding (P < 0.05). Therefore, fifteen patients were needed in each group.

Statistical analysis: All statistical analyses were performed blinded to group allocation using StatView 5.0 (SAS Institute Inc., Cary, NC, USA). All efficacy end points at weeks 0, 2, 4 and 8 were compared between the two treatment regimens. Continuous variables were presented as mean+/-SD (standard deviation) and discrete variables presented as numbers and percentages. We used one-way analysis of variance for repeated measures (ANOVA), followed by Fisher’s protected least significant difference (PLSD) post hoc test to assess differences between therapeutic regimens. Wilcoxon rank test was used to test the significance of difference in any place where the normality of distribution was in question. A paired student t-test established the differences between the pre-treatment and post-treatment values in both the test and control groups. All data analysis were based on an ‘intention to treat’ (ITT) approach, including all patients randomised, whether treated or not, and including all patients who withdrew prematurely. All statistical tests were two sided and performed at an alpha level of 0.05. All the data were reported as median (and range) or mean (+/- SD) for non-parametric and parametric distributions, respectively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 289943 0
Other
Name [1] 289943 0
Mr Bob Armstrong/University of Canberra
Address [1] 289943 0
2 Guy Street
Kings Meadows
Tasmania
7249
Country [1] 289943 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Avenue Rd
Sandy Bay
Hobart
Tasmania 7005
Country
Australia
Secondary sponsor category [1] 288633 0
None
Name [1] 288633 0
Address [1] 288633 0
Country [1] 288633 0
Other collaborator category [1] 278155 0
Other
Name [1] 278155 0
Dr Susan Basson
Address [1] 278155 0
Dr. Sue Basson’s Clinic
98 Talbot Road, Kings Meadows, Launceston, Tasmania, Australia
Postcode: 7249
Country [1] 278155 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291657 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 291657 0
Private Bag 01, Hobart, Tasmania 7001, Australia
Ethics committee country [1] 291657 0
Australia
Date submitted for ethics approval [1] 291657 0
13/05/2006
Approval date [1] 291657 0
12/09/2006
Ethics approval number [1] 291657 0
H0008454

Summary
Brief summary
Psoriasis is a common, non-infectious inflammatory disease characterised by distinctive erythematous scaling plaques of varying sizes usually on the scalp, elbows, knees and other surfaces of the skin. There is no satisfactory or effective cure for psoriasis. Both oral and topical treatment modalities are only partially effective and can induce irritation and/or serious side-effects. Current treatment options are only effective in reducing psoriasis symptoms temporarily. About 70% of subjects are said to prefer topical therapy to manage psoriasis. Myrtaceous essential oils have been found to provide anti-inflammatory effects on human skin. A safe, relatively inexpensive, alternative topical treatment is required to minimise treatment failures and relapses associated with psoriasis. The present study compared the efficacy and safety of topical kunzea oil (twice daily) with 5% Liquor Carbonis Detergens (LCD) and 3% salicylic acid containing formulations (twice daily) for the management mild to moderate psoriasis (study duration 8 weeks). The study recruited patients from single site (GP surgery, Talbot Rd, Launceston).
Trial website
NIL
Trial related presentations / publications
Thomas J, Narkowicz, CK, Peterson, GM, Jacobson, GA & Basson S, ‘An evaluation of the clinical efficacy of kunzea oil formulations in the therapeutic management of psoriasis in adults’, Proceedings of the APSA Annual Conference, Hobart, (2009)
Public notes
NIL

Contacts
Principal investigator
Name 51378 0
Dr Jackson Thomas
Address 51378 0
University of Canberra Faculty of Health, University of Canberra, Kirrinari Street, ACT 2601
Country 51378 0
Australia
Phone 51378 0
+61 (0)2 62068928
Fax 51378 0
+61 (0)2 6201 5727
Email 51378 0
Jackson.Thomas@canberra.edu.au
Contact person for public queries
Name 51379 0
Dr Jackson Thomas
Address 51379 0
University of Canberra Faculty of Health, University of Canberra, Kirrinari Street, ACT 2601
Country 51379 0
Australia
Phone 51379 0
+61 (0)2 62068928
Fax 51379 0
+61 (0)2 6201 5727
Email 51379 0
Jackson.Thomas@canberra.edu.au
Contact person for scientific queries
Name 51380 0
Dr Jackson Thomas
Address 51380 0
University of Canberra Faculty of Health, University of Canberra, Kirrinari Street, ACT 2601
Country 51380 0
Australia
Phone 51380 0
+61 (0)2 62068928
Fax 51380 0
+61 (0)2 6201 5727
Email 51380 0
Jackson.Thomas@canberra.edu.au