ECMT-154™ for the Topical Treatment of Eczema
Randomised Controlled Trial of ECMT-154™ vs Vehicle Control for the Topical Treatment of Eczema in Adults
Manuka Biosciences
118 participants
Jan 20, 2022
Interventional
Conditions
Summary
This study is a single blind, vehicle-controlled trial of 118 participants with moderate to severe eczema. Participants will be recruited from community pharmacies by pharmacy staff. 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 will be instructed to apply their treatment twice daily for six weeks. Participants will complete a weekly electronic diary for five weeks. The electronic diaries will capture symptom scores, treatment compliance, and adverse events. The participants 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, 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
Inclusion Criteria8
- Participant has the ability and willingness to sign a written informed consent using a digital signature or paper form if back up is required
- Participant is aged between 18 and 65 years of age, inclusive
- Participant reported, Physician diagnosis of eczema
- Participant has a POEM category score of ‘moderate or severe eczema’ (8 to 24)
- Participant is willing to stop all moisturisers and/or other skin barrier cream or emulsion treatments during the test period and replace with the investigational product assigned in this trial
- Participant is willing to replace their body wash and/or soaps with Aqueous cream as supplied at enrolment
- Participant is able and willing to attend the follow up visit during the visit window
- Participant is able and willing to complete the study and to comply with all study instructions
Exclusion Criteria8
- Current requirement for prescription of antibiotics or corticosteroids for the treatment of any condition (with the exception of inhaled corticosteroids)
- Use of antibiotics, corticosteroids, calceneurin inhibitors, or antihistamines within the last four weeks (with the exception of inhaled corticosteroids)
- Cutaneous mycotic or bacterial disease requiring a topical or systemic therapy
- Other skin condition which may affect the assessment of eczema severity
- History of allergy or hypersensitivity to the ingredients of the study treatments
- Participation in a clinical trial involving an investigational product during the last three months
- Participant is pregnant or planning to become pregnant during the study
- 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.
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Interventions
Manuka-oil based 1% ECMT-154 cream Applied topically, twice daily, for six weeks The amount applied will vary by eczema spread. Participants are recommended to apply the treatment liberally to the affected areas. A weekly participant diary will be used to monitor adherence.
Locations(1)
View Full Details on ANZCTR
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ACTRN12621001096842