@article{shortt_manuka_2024,
	title = {Mānuka oil based {ECMT}-154 versus vehicle control for the topical treatment of eczema: study protocol for a randomised controlled trial in community pharmacies in {Aotearoa} {New} {Zealand}},
	volume = {24},
	issn = {2662-7671},
	shorttitle = {Mānuka oil based {ECMT}-154 versus vehicle control for the topical treatment of eczema},
	url = {https://bmccomplementalternmed.biomedcentral.com/articles/10.1186/s12906-024-04358-9},
	doi = {10.1186/s12906-024-04358-9},
	abstract = {Abstract 
             
              Background 
              Eczema is a chronic, relapsing skin condition commonly managed by emollients and topical corticosteroids. Prevalence of use and demand for effective botanical therapies for eczema is high worldwide, however, clinical evidence of benefit is limited for many currently available botanical treatment options. Robustly-designed and adequately powered randomised controlled trials (RCTs) are essential to determine evidence of clinical benefit. This protocol describes an RCT that aims to investigate whether a mānuka oil based emollient cream, containing 2\% ECMT-154, is a safe and effective topical treatment for moderate to severe eczema. 
             
             
              Methods 
              This multicentre, single-blind, parallel-group, randomised controlled trial aims to recruit 118 participants from community pharmacies in Aotearoa New Zealand. Participants will be randomised 1:1 to receive topical cream with 2\% ECMT-154 or vehicle control, and will apply assigned treatment twice daily to affected areas for six weeks. The primary outcome is improvement in subjective symptoms, assessed by change in POEM score. Secondary outcomes include change in objective symptoms assessed by SCORAD (part B), PO-SCORAD, DLQI, and treatment acceptability assessed by TSQM II and NRS. 
             
             
              Discussion 
              Recruitment through community pharmacies commenced in January 2022 and follow up will be completed by mid-2023. This study aims to collect acceptability and efficacy data of mānuka oil based ECMT-154 for the treatment of eczema. If efficacy is demonstrated, this topical may provide an option for a novel emollient treatment. The community-based design of the trial is anticipated to provide a generalisable result. 
             
             
              Ethics and dissemination 
              Ethics approval was obtained from Central Health and Disability Ethics Committee (reference: 2021 EXP 11490). Findings of the study will be disseminated to study participants, published in peer-reviewed journal and presented at scientific conferences. 
             
             
              Trial registration 
               
                Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621001096842. Registered on August 18, 2021 ( 
                https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382412\&isReview=true 
                ). 
               
             
             
              Protocol version 
              2.1 (Dated 18/05/2022).},
	language = {en},
	number = {1},
	urldate = {2024-05-30},
	journal = {BMC Complementary Medicine and Therapies},
	author = {Shortt, Gabrielle and Shortt, Nicholas and Bird, Georgina and Kerse, Kyley and Lieffering, Nico and Martin, Alexander and Eathorne, Allie and Black, Bianca and Kim, Bob and Rademaker, Marius and Reiche, Louise and Paa, Selwyn Te and Harding, Suki and Armour, Mike and Semprini, Alex},
	month = jan,
	year = {2024},
	pages = {61},
}

{"_id":"ezhz4PaRXSdAJvqLZ","bibbaseid":"shortt-shortt-bird-kerse-lieffering-martin-eathorne-black-etal-mnukaoilbasedecmt154versusvehiclecontrolforthetopicaltreatmentofeczemastudyprotocolforarandomisedcontrolledtrialincommunitypharmaciesinaotearoanewzealand-2024","author_short":["Shortt, G.","Shortt, N.","Bird, G.","Kerse, K.","Lieffering, N.","Martin, A.","Eathorne, A.","Black, B.","Kim, B.","Rademaker, M.","Reiche, L.","Paa, S. T.","Harding, S.","Armour, M.","Semprini, A."],"bibdata":{"bibtype":"article","type":"article","title":"Mānuka oil based ECMT-154 versus vehicle control for the topical treatment of eczema: study protocol for a randomised controlled trial in community pharmacies in Aotearoa New Zealand","volume":"24","issn":"2662-7671","shorttitle":"Mānuka oil based ECMT-154 versus vehicle control for the topical treatment of eczema","url":"https://bmccomplementalternmed.biomedcentral.com/articles/10.1186/s12906-024-04358-9","doi":"10.1186/s12906-024-04358-9","abstract":"Abstract Background Eczema is a chronic, relapsing skin condition commonly managed by emollients and topical corticosteroids. Prevalence of use and demand for effective botanical therapies for eczema is high worldwide, however, clinical evidence of benefit is limited for many currently available botanical treatment options. Robustly-designed and adequately powered randomised controlled trials (RCTs) are essential to determine evidence of clinical benefit. This protocol describes an RCT that aims to investigate whether a mānuka oil based emollient cream, containing 2% ECMT-154, is a safe and effective topical treatment for moderate to severe eczema. Methods This multicentre, single-blind, parallel-group, randomised controlled trial aims to recruit 118 participants from community pharmacies in Aotearoa New Zealand. Participants will be randomised 1:1 to receive topical cream with 2% ECMT-154 or vehicle control, and will apply assigned treatment twice daily to affected areas for six weeks. The primary outcome is improvement in subjective symptoms, assessed by change in POEM score. Secondary outcomes include change in objective symptoms assessed by SCORAD (part B), PO-SCORAD, DLQI, and treatment acceptability assessed by TSQM II and NRS. Discussion Recruitment through community pharmacies commenced in January 2022 and follow up will be completed by mid-2023. This study aims to collect acceptability and efficacy data of mānuka oil based ECMT-154 for the treatment of eczema. If efficacy is demonstrated, this topical may provide an option for a novel emollient treatment. The community-based design of the trial is anticipated to provide a generalisable result. Ethics and dissemination Ethics approval was obtained from Central Health and Disability Ethics Committee (reference: 2021 EXP 11490). Findings of the study will be disseminated to study participants, published in peer-reviewed journal and presented at scientific conferences. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621001096842. Registered on August 18, 2021 ( https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382412&isReview=true ). Protocol version 2.1 (Dated 18/05/2022).","language":"en","number":"1","urldate":"2024-05-30","journal":"BMC Complementary Medicine and Therapies","author":[{"propositions":[],"lastnames":["Shortt"],"firstnames":["Gabrielle"],"suffixes":[]},{"propositions":[],"lastnames":["Shortt"],"firstnames":["Nicholas"],"suffixes":[]},{"propositions":[],"lastnames":["Bird"],"firstnames":["Georgina"],"suffixes":[]},{"propositions":[],"lastnames":["Kerse"],"firstnames":["Kyley"],"suffixes":[]},{"propositions":[],"lastnames":["Lieffering"],"firstnames":["Nico"],"suffixes":[]},{"propositions":[],"lastnames":["Martin"],"firstnames":["Alexander"],"suffixes":[]},{"propositions":[],"lastnames":["Eathorne"],"firstnames":["Allie"],"suffixes":[]},{"propositions":[],"lastnames":["Black"],"firstnames":["Bianca"],"suffixes":[]},{"propositions":[],"lastnames":["Kim"],"firstnames":["Bob"],"suffixes":[]},{"propositions":[],"lastnames":["Rademaker"],"firstnames":["Marius"],"suffixes":[]},{"propositions":[],"lastnames":["Reiche"],"firstnames":["Louise"],"suffixes":[]},{"propositions":[],"lastnames":["Paa"],"firstnames":["Selwyn","Te"],"suffixes":[]},{"propositions":[],"lastnames":["Harding"],"firstnames":["Suki"],"suffixes":[]},{"propositions":[],"lastnames":["Armour"],"firstnames":["Mike"],"suffixes":[]},{"propositions":[],"lastnames":["Semprini"],"firstnames":["Alex"],"suffixes":[]}],"month":"January","year":"2024","pages":"61","bibtex":"@article{shortt_manuka_2024,\n\ttitle = {Mānuka oil based {ECMT}-154 versus vehicle control for the topical treatment of eczema: study protocol for a randomised controlled trial in community pharmacies in {Aotearoa} {New} {Zealand}},\n\tvolume = {24},\n\tissn = {2662-7671},\n\tshorttitle = {Mānuka oil based {ECMT}-154 versus vehicle control for the topical treatment of eczema},\n\turl = {https://bmccomplementalternmed.biomedcentral.com/articles/10.1186/s12906-024-04358-9},\n\tdoi = {10.1186/s12906-024-04358-9},\n\tabstract = {Abstract \n \n Background \n Eczema is a chronic, relapsing skin condition commonly managed by emollients and topical corticosteroids. Prevalence of use and demand for effective botanical therapies for eczema is high worldwide, however, clinical evidence of benefit is limited for many currently available botanical treatment options. Robustly-designed and adequately powered randomised controlled trials (RCTs) are essential to determine evidence of clinical benefit. This protocol describes an RCT that aims to investigate whether a mānuka oil based emollient cream, containing 2\\% ECMT-154, is a safe and effective topical treatment for moderate to severe eczema. \n \n \n Methods \n This multicentre, single-blind, parallel-group, randomised controlled trial aims to recruit 118 participants from community pharmacies in Aotearoa New Zealand. Participants will be randomised 1:1 to receive topical cream with 2\\% ECMT-154 or vehicle control, and will apply assigned treatment twice daily to affected areas for six weeks. The primary outcome is improvement in subjective symptoms, assessed by change in POEM score. Secondary outcomes include change in objective symptoms assessed by SCORAD (part B), PO-SCORAD, DLQI, and treatment acceptability assessed by TSQM II and NRS. \n \n \n Discussion \n Recruitment through community pharmacies commenced in January 2022 and follow up will be completed by mid-2023. This study aims to collect acceptability and efficacy data of mānuka oil based ECMT-154 for the treatment of eczema. If efficacy is demonstrated, this topical may provide an option for a novel emollient treatment. The community-based design of the trial is anticipated to provide a generalisable result. \n \n \n Ethics and dissemination \n Ethics approval was obtained from Central Health and Disability Ethics Committee (reference: 2021 EXP 11490). Findings of the study will be disseminated to study participants, published in peer-reviewed journal and presented at scientific conferences. \n \n \n Trial registration \n \n Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621001096842. Registered on August 18, 2021 ( \n https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382412\\&isReview=true \n ). \n \n \n \n Protocol version \n 2.1 (Dated 18/05/2022).},\n\tlanguage = {en},\n\tnumber = {1},\n\turldate = {2024-05-30},\n\tjournal = {BMC Complementary Medicine and Therapies},\n\tauthor = {Shortt, Gabrielle and Shortt, Nicholas and Bird, Georgina and Kerse, Kyley and Lieffering, Nico and Martin, Alexander and Eathorne, Allie and Black, Bianca and Kim, Bob and Rademaker, Marius and Reiche, Louise and Paa, Selwyn Te and Harding, Suki and Armour, Mike and Semprini, Alex},\n\tmonth = jan,\n\tyear = {2024},\n\tpages = {61},\n}\n\n","author_short":["Shortt, G.","Shortt, N.","Bird, G.","Kerse, K.","Lieffering, N.","Martin, A.","Eathorne, A.","Black, B.","Kim, B.","Rademaker, M.","Reiche, L.","Paa, S. 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