Kunzea oil for the management of mild to moderate psoriasis (a common, chronic, relapsing, immune-mediated skin disease: a pilot randomised controlled trial.
- Conditions
- Psoriasis of the body and scalpSkin - Dermatological conditionsAlternative and Complementary Medicine - Other alternative and complementary medicineInflammatory and Immune System - Other inflammatory or immune system disorders
- Registration Number
- ACTRN12614001014640
- Lead Sponsor
- niversity of Tasmania
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Entry criteria required a clinical diagnosis of psoriasis involving greater than or equal to 10% of the body surface.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>Reference: Fredriksson T, Pettersson U. Severe psoriasis–oral therapy with a new retinoid. Dermatology 1978;157:238-244.<br>[Timepoint: At baseline and 8 weeks after randomisation]
- Secondary Outcome Measures
Name Time Method 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.<br><br><br>Reference<br>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.<br><br>[Timepoint:At baseline and 8 weeks after randomisation]