None listed
Conditions
Brief summary
The prevalence of scabies is significant in Aboriginal and Torres Strait Islander children in Australia, affecting about 7 in 10 at any given time, more than six times the rate seen in the rest of the developed world. Existing scabies treatments have been associated with serious side effects and there is evidence of increasing resistance of scabies mites leading to treatment failures. These public health concerns clearly demonstrate the need for further clinical studies into alternative treatments. Tea tree oil (TTO) has shown promising results in preliminary studies and has been successfully used as an antimicrobial agent for several decades. Pre-clinical investigations have demonstrated that TTO out-performs widely used scabicidal agents (such as permethrin 5% cream and ivermectin) when tested against scabies mites in a laboratory setting. However, current data are insufficient to warrant a broad recommendation for its use for the management of scabies in a wider population because previous studies were small (interventional case studies focused on a small group of hospitalised patients) and limited to in vitro observations. The aim of this research is to examine the effectiveness and safety of a simple and low-cost TTO gel treatment as compared to permethrin cream in treating paediatric scabies infestation and preventing associated secondary bacterial infection in Aboriginal and Torres Strait Islander children living in remote Australia. The 200 participants will be aged 5-16 and randomised (1:1) into control treatment [permethrin 5% cream] and test treatment [5% TTO-gel] groups. The primary outcome investigated in this study will be the cure (i.e. complete resolution) or improvement of scabies skin lesion within 4 weeks after treatment. Other outcome measures determined will include relief of symptoms, scabies recurrence rate, patient compliance with treatment regimen, adverse effects and patient acceptability.
Interventions
Test group - treatment of scabies infestation with a topical 5% v/w Tea Tree Oil (TTO) gel, applied twice (day 1 and day 7)
The test medication (5% v/w TTO gel) will be applied on days 1 and 7 of the trial, and the treatment will be left on the body for 8 to 12 hours, after which children will shower with non-medicated soap and water.
The treatment formulations (for both the test and control group participants) will be applied chin down by the patient or carer wearing plastic gloves and gowns
Test group - treatment of scabies infestation with a topical 5% v/w Tea Tree Oil (TTO) gel, applied twice (day 1 and day 7) The test medication (5% v/w TTO gel) will be applied on days 1 and 7 of the trial, and the treatment will be left on the body for 8 to 12 hours, after which children will shower with non-medicated soap and water. The treatment formulations (for both the test and control group participants) will be applied chin down by the patient or carer wearing plastic gloves and gowns. Patients will be bathed (as usual) and bed linen changed before applying the treatment. The formulations will be applied to every square inch of skin, from the posterior ear folds down over the entire body. This includes intergluteal cleft, umbilicus, skin folds, palms and soles, and webs between fingers and toes. The area behind the ears will be given special attention while avoiding eyes and mouth. Fingernails and toenails will be clipped and the scabies formulations applied under nails. Clean clothing will be put on after applying the treatment. The study participants and carers will be given additional personal protective equipment such as disposable, long sleeve gowns and gloves for direct patient care to prevent reinfestation. Participants will be instructed to wash contaminated clothing and linens in the hot cycle of the washing machine and dry in the hot cycle of the dryer for 10-20 minutes or dried under hot sunlight. If trial medication is washed off during hand washing, toileting, or perineal care, it will be reapplied. The formulation will be applied at night after the evening bath (with a non-medicated soap). Treatment will be overseen by a group of senior GPs at the Wurli-Wurlinjang Health Service. In order to prevent and contain spread of scabies, all other family contacts will be offered standard first-line scabies treatment (Lyclear, permethrin 5% cream) with instructions for use at home. The permethrin cream will be provided in visually distinguishable containers with clear instructions using coloured labels to prevent medication errors. Crusted scabies-infested house contacts will be treated with a combination of standard oral and topical therapy by the physician. Participants will be advised not to use or mix any other scabies treatment with trial medications. Patients living in a house with crusted scabies-infested house mates will be given ACTELLIC 50 EC (pirimiphos methyl, insecticide), with labelled instructions for use to clean the house (e.g. floors and walls). Test formulations (5% v/w TTO gel in an aqueous base) will be prepared following WHO Good Manufacturing Practices (GM, IDT Australia, VIC) and all formulations will be supplied in appropriate child-safe medicine containers, labelled with the child’s identifiers and dosing (application) instructions. Compliance: Innovative strategies will be employed to motivate trial participants’ compliance to the treatment protocol. These include providing each trial participant with a tablet with pre-set alarms to remind them and pre-loaded engaging video tutorials in relevant Aboriginal languages to facilitate the correct and easy application of trial medications. Further, a limited supply of washing machines (n=30) will be provided to appropriate participating communities to better control the scabies infestation in the local communities and to facilitate the accomplishment of long-term treatment goals. Healthcare home visits by Indigenous health workers (every week during the course of study) will be organised to enhance patients’ adherence to the treatment protocol. Further, gift vouchers (e.g. prepaid telephone cards and grocery vouchers) will be given to participants to compensate for patient transport to the study centre for follow-up assessments. An experienced and appropriately qualified study nurse (employed at the trial site) will review each patient by phone to record any apparent adverse effects and to assess adherence to treatment protocol. During the treatment phase, the participant/parent/carer will also receive daily SMS alerts in the morning to remind them about the treatment application. Further, patient compliance to the treatment protocols will be assessed (subjectively) by weighing the tubes of medications prior to the supply and at the end of treatment. Parents/carers will be reminded by nursing staff to return the formulations and tablets at the end of week 1. As a bush medicine used in Aboriginal healing practices for centuries, TTO is likely to be accepted by study participants.
Sponsors
University of Canberra
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1) Presence of typical scabietic lesions, for example papules, nodules, or vesicles at classical sites (including but not limited to the following sites of predilection: face, head, palms, interdigit, sides of fingers, upper and lower extremities, wrists, elbows, axilla, nipple, umbilical area and/or lower abdomen, genitalia, inguinal, buttocks and back area); 2) Presence of classical burrows on clinical examination; 3) Nocturnal pruritus; 4) History of similar symptoms among family members or close contacts.
Exclusion criteria
1) Treatment with any topical scabicidal therapy in the month before entry into the study; 2) Use of any topical or systemic therapy in the week before entry; 3) Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection; 4) Presence of scabies with an atypical presentation, like crusted scabies or scabies incognito; 5) Presence of any other skin disease which could alter the picture of scabies; 6) Known history of allergy to any of the study medications (permethrin, tea tree oil or other essential oils); 7) Receipt of more than 2 weeks of immuno-suppressants or immune modifying drugs, (e.g. prednisolone >0.5 mg/kg/day).
Outcome results
None listed