CompletedPhase 2ACTRN12622000684729

ECMT-154™ for the Topical Treatment of Eczema in Children

Randomised Controlled Trial of ECMT-154™ vs Vehicle Control for the Topical Treatment of Eczema in Children aged 2-12 YO

Sponsor

Manuka Biosciences

Enrollment

50 participants

Start Date

Aug 2, 2022

Study Type

Interventional

Conditions

Eczema

Summary

This study is a randomised vehicle-controlled trial of 50 pediatric participants with moderate to severe eczema. In this study investigators who obtain consent are not aware of the randomised treatment. Participants and their parent/guardian will be recruited from community pharmacies by pharmacy staff, social media advertising, or those referred from a local GP. Pharmacy staff will be trained as investigators by a MRINZ investigator. The baseline visit will consist of screening, consent, demographics, eczema scoring, photo capture of a representative eczema lesion, randomisation and supply of study medication. Participants' parent/guardian will be instructed to apply their treatment twice daily for six weeks. In this study central investigators are not aware of the randomised treatment. Participants and their parent/guardian will not be informed of their treatment allocation, however the odour of ECMT-154™ will not be an exact match to vehicle control. Participants and their parent/guardian are therefore considered unblinded. Pharmacy investigators will be blind to treatment allocation, with the IMP delivered in masked and non-descript dispensing systems labelled with details on the product type and with application instructions only. Participants' parent/guardian will complete a weekly electronic diary for six weeks. The electronic diaries will capture symptom scores, treatment compliance, and adverse events. The participants with their parent/guardian will return to the pharmacy at the end of week six for a final study visit. The final visit will consist of eczema scoring, photo capture of a representative eczema lesion, treatment acceptability, adverse event collection, and concomitant medication collection. A survey completed by the parent/guardian, two weeks after the final visit, will capture information about adverse events post intervention period. The primary outcome for this study is improvement in patient-reported symptoms at six weeks. Secondary outcomes include improvement in patient-reported clinical signs, improvement in patient reported quality of life, and inter-rater validity of SCORAD (intensity section) between a blinded dermatologist and pharmacy investigators.

Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 12 Yearss

Inclusion Criteria11

Willing and able to provide written informed consent (parent/guardian) and assent (for participants aged 5-12 years)
Participant is aged between 2 and 12 years of age, inclusive
Parent/guardian reported, doctor diagnosis of eczema
Patient has a representative eczema lesion, located below the clavicle that is in an area they are comfortable to have photographed.
Patient has a POEM score of ‘moderate to severe eczema’ (8 to 24)
Participant and parent/guardian are willing to stop all moisturisers and other skin barrier cream or emulsion used on participant during the treatment period and replace it with the investigational
product assigned in this trial. Usual facial regimens and application of sunscreen is permitted.
Participant and parent/guardian are willing to replace participants body wash/soap with aqueous cream as supplied at enrolment.
Participant and their parent/guardian are able to attend a follow up visit 6 weeks after they enroll in the study. This will take place at a participating pharmacy or via telephone call if required due to COVID restrictions or unanticipated inability to attend in person.
Participant and their parent/guardian are willing and able to complete the study and comply with all study instructions.
Parent/guardian must have internet access and ability to take a once weekly photograph of the representative eczema lesion for completing the online study diaries.

Exclusion Criteria11

Current requirement for prescription of antibiotics or corticosteroids for the treatment of any condition (with the exception of in and intranasal corticosteroids)
Use of antihistamines, antibiotics or corticosteroids within the last two weeks (with the exception of inhaled and intranasal corticosteroids)
Use of immunomodulatory medications taken for eczema within the last four weeks
Use of bleach baths within the past seven days.
Cutaneous mycotic or bacterial disease requiring a topical or systemic therapy
Other skin condition which may affect the assessment of eczema
History of allergy or hypersensitivity to study treatment ingredients
Participation in a clinical study involving an investigational product during the last three months.
Current cold/flu like symptoms, fever, or unexplained shortness of breath..
Any other condition which, at the investigators’ discretion, is believed may present a safety risk or impact upon the ability of the
participant to complete the study.

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Interventions

Manuka-oil based 2% ECMT-154™ cream is applied topically, twice daily (morning and night) for 6 weeks. The amount required will be dependent on the individual child's eczema spread, with the participants' parent/guardian recommended to apply the treatment liberally to their eczema areas. A weekly participant diary will used by the participants' parent/guardian to monitor adherence, adverse events and to capture photographs of the representative eczema lesion. Composition Ingredients: Propylene Glycol, Sodium lauryl sulfate, Stearyl alcohol, water, White soft paraffin, PEG 3350, PEG 300, 2% ECMT-154