PMID- 33463052 OWN - NLM STAT- MEDLINE DCOM- 20211203 LR - 20211214 IS - 2001-1326 (Print) IS - 2001-1326 (Electronic) IS - 2001-1326 (Linking) VI - 11 IP - 1 DP - 2021 Jan TI - Add-on effect of PSORI-CM01 to topical calcipotriol for moderate psoriasis vulgaris: A multi-center, randomized, double-blind pilot study. PG - e286 LID - 10.1002/ctm2.286 [doi] LID - e286 AB - BACKGROUND: Mild-moderate psoriasis vulgaris is a common dermatological autoimmune condition with limited conventional therapeutic options. Safe and effective adjunct therapies to topical non-steroidal antipsoriatic therapy are needed. The oral Chinese herbal medicine (CHM) formula PSORI-CM01 has been evidenced potential antipsoriatic pharmacological activity. This article reports a pilot study which was designed as a double-blinded, placebo-controlled randomized controlled trial (RCT) evaluating the effects of PSORI-CM01 when added to topical calcipotriol cream. METHODS: People with moderate psoriasis vulgaris were randomized to receive oral PSORI-CM01 or placebo administered for 12 weeks in combination with calcipotriol. The primary clinical outcome was the change of psoriasis area severity index (PASI) score at week 12 and week 24. Secondary clinical outcomes were PASI75, PASI50, relapse rate, change in body surface area, dermatology life quality index and Skindex29, and adverse events (AEs). Participants' satisfaction and willingness to repeat were also assessed. RESULTS: The pilot study was conducted in Australia and China, 29 participants were randomized with 26 completed the treatment and follow-up. Participants' baseline basic characteristics were comparable. No between-group statistical significance was found on pre-defined clinical outcome measures, although there seemed a trend of treatment effects favoring the combination of PSORI-CM01 with calcipotriol. Frequency and severity of AEs were similar between two groups, with no severe AEs reported. CONCLUSIONS: The design and duration of the study appears feasible. A proper powered RCT with slight adjustments in the methods is needed to reveal the add-on effects of oral CHM PSORI-CM01. The experience and results from this pilot study will contribute to the refine of objectives and design of a future study, and assist the sample size calculation for the full-scale RCT. CI - (c) 2021 The Authors. Clinical and Translational Medicine published by John Wiley & Sons Australia, Ltd on behalf of Shanghai Institute of Clinical Bioinformatics. FAU - Parker, Shefton AU - Parker S AD - China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia. FAU - Zhang, Anthony Lin AU - Zhang AL AD - China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia. FAU - Zhang, Claire Shuiqing AU - Zhang CS AUID- ORCID: 0000-0003-3866-602X AD - China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia. FAU - Goodman, Greg AU - Goodman G AD - The Dermatological Institute of Victoria, South Yarra, Victoria, Australia. FAU - Wen, Zehuai AU - Wen Z AD - China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia. AD - Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. AD - Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China. FAU - Yan, Yuhong AU - Yan Y AD - Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. AD - Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China. FAU - Yao, Danni AU - Yao D AD - Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. AD - Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China. FAU - Wu, Huimei AU - Wu H AD - Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. AD - Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China. FAU - Deng, Hao AU - Deng H AD - Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. AD - Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China. FAU - Lu, Chuanjian AU - Lu C AD - China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia. AD - Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. AD - Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China. AD - The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China. FAU - Xue, Charlie Changli AU - Xue CC AD - China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia. AD - Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. AD - Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China. AD - The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China. LA - eng SI - ANZCTR/ACTRN12614000493640 PT - Letter PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Clin Transl Med JT - Clinical and translational medicine JID - 101597971 RN - 0 (Dermatologic Agents) RN - 0 (Drugs, Chinese Herbal) RN - 0 (PSORI-CM01) RN - 143NQ3779B (calcipotriene) RN - FXC9231JVH (Calcitriol) MH - Administration, Topical MH - Adult MH - Calcitriol/administration & dosage/*analogs & derivatives/pharmacology MH - Dermatologic Agents/*pharmacology MH - Double-Blind Method MH - Drug Therapy, Combination/methods MH - Drugs, Chinese Herbal/*pharmacology MH - Female MH - Humans MH - Male MH - Pilot Projects MH - Psoriasis/*drug therapy MH - Treatment Outcome PMC - PMC7809599 OTO - NOTNLM OT - Chinese herbal medicine OT - calcipotriol OT - clinical trial OT - pilot OT - placebo OT - psoriasis COIS- The authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported. EDAT- 2021/01/20 06:00 MHDA- 2021/01/20 06:01 PMCR- 2021/01/15 CRDT- 2021/01/19 06:05 PHST- 2020/10/31 00:00 [received] PHST- 2020/12/26 00:00 [revised] PHST- 2020/12/29 00:00 [accepted] PHST- 2021/01/19 06:05 [entrez] PHST- 2021/01/20 06:00 [pubmed] PHST- 2021/01/20 06:01 [medline] PHST- 2021/01/15 00:00 [pmc-release] AID - CTM2286 [pii] AID - 10.1002/ctm2.286 [doi] PST - ppublish SO - Clin Transl Med. 2021 Jan;11(1):e286. doi: 10.1002/ctm2.286.