CompletedPhase 2ACTRN12614001014640

Kunzea oil for the management of mild to moderate psoriasis (a common, chronic, relapsing, immune-mediated skin disease: a pilot randomised controlled trial.

Safety and efficacy of kunzea oil-containing formulations for the management of psoriasis, a pilot, randomised, controlled trial.


Sponsor

University of Tasmania

Enrollment

30 participants

Start Date

Aug 13, 2007

Study Type

Interventional

Conditions

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).


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Entry criteria required a clinical diagnosis of psoriasis involving greater than or equal to 10% of the body surface.

Exclusion Criteria1

  • 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.

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Interventions

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. Th

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.


Locations(1)

TAS, Australia

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ACTRN12614001014640