None listed
Conditions
Brief summary
This study aims to investigate whether it is possible to recruit children for an impetigo study by utilising local pharmacies nationwide. This feasibility study primarily aims to assess whether the community pharmacy setting is an effective clinical setting in recruiting and randomising uncomplicated impetigo in 50 children aged two to 14 years. Participants will be recruited from community pharmacies by pharmacy staff. Pharmacy staff will be trained as investigators by a MRINZ investigator. Participants will be randomised to receive the investigational product (Tripalma™) or active antiseptic control (1% H2O2) to apply topically to impetigo lesion for seven days. The randomised treatment will be applied twice daily, following simple wound cleansing procedures. Participants will complete an online diary twice daily to record treatment adherence, impetigo symptoms, adverse events and capture a photograph of the lesion for remote SIRS scoring by a study investigator. Primary outcome is the study feasibility to recruit in the pharmacy setting, measured by the proportion of screened participants that were randomised. Secondary outcomes will collect signals of efficacy previously used in pivotal studies of impetigo, safety, tolerability and acceptability of randomised treatments.
Interventions
Participants will be randomised to receive either 1% H2O2 (Crystaderm) or a formulation containing 2% Palmarosa oil and 2% Manuka oil ß-triketones (Tripalma).
The topical treatment will be applied twice a day for 7 days. Each application will be preceded by a simple wound care process. Using surgical gloves, the impetigo lesion will be cleansed using saline and sterile gauze, softening the scab and removing where possible. A sufficient quantity of topical study treatment will be applied to pro
Participants will be randomised to receive either 1% H2O2 (Crystaderm) or a formulation containing 2% Palmarosa oil and 2% Manuka oil ß-triketones (Tripalma). The topical treatment will be applied twice a day for 7 days. Each application will be preceded by a simple wound care process. Using surgical gloves, the impetigo lesion will be cleansed using saline and sterile gauze, softening the scab and removing where possible. A sufficient quantity of topical study treatment will be applied to provide a thin covering of the entire lesion and two millimeters of surrounding skin. This will be followed by the application of an occlusive dressing where practical. At visit one wound care and treatment application will be done by the pharmacist. During the rest of the intervention period, the parent/guardian will apply the topical treatment to the participant. The parent/guardian will complete a twice-daily online diary to capture a photograph of the impetigo lesion, monitor adherence, and adverse events. This diary is anticipated to take 5-10 minutes to complete and will be completed during treatment application to guide the parent/guardian through the process.
Sponsors
Manuka Biosciences
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
- Willing to provide written informed consent (parent(s)/guardian(s)) - Willing to provide written informed assent (participants aged 7-14, assent is not required for participants younger than 7.) - Participant is aged between 2 and 14 years of age, inclusive - Doctor, Nurse or Pharmacist confirmed episode of impetigo - Three or fewer impetigo lesions at day 1 with one in area participants and caregivers are comfortable to photograph. Presence of impetigo at one distinct anatomical location will be classified as one lesion (e.g. mouth, nose, right arm) - Onset of disease within 48 hours of visit one - Current impetigo lesion remains untreated with any topical or systemic therapy, simple wound cleansing permitted - Skin Infection Rating Scale (SIRS) score of 3 or more, with a score of 1 or more in the pus/exudate domain. - Participant and parent/caregiver is willing to stop all moisturisers, soap products and/or other skin barrier cream or emulsion treatments from being applied to the affected areas of skin during the study period. Immersion in bath water or a shower is permitted - Participant and parent/caregiver are able to be contacted by telephone for a follow up visit 21 days after they enrol in the study - Participant and parent/caregiver must have internet access on a smartphone for completing the online study diaries and the ability to take a photo of the infected area on their phone twice a day.
Exclusion criteria
- Cellulitis in area of lesion or any other location - Tympanic temperature > 38°C - Current requirement or use of antibiotics for the treatment of any condition - Use of any topical antibiotic within the last two weeks - Use of any systemic antibiotic within the last four weeks - Any use of topical steroid within 10cm of the active lesion under assessment - Any use of topical antihistamine within 10cm of the active lesion under assessment - Any use of oral antihistamine that is not established and regular within three weeks of enrolment - Other skin condition which may affect the assessment of impetigo severity - History of allergy or hypersensitivity to study treatment ingredients and wound dressing. - Participation in a clinical trial involving an investigational product during the last one month - Meets any High Index of Suspicion criteria for COVID-19 as per current Ministry of Health guidance - Cold/flu-like symptoms, fever, or unexplained shortness of breath in the past 14 days. - 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.
Outcome results
None listed