PMID- 31419323
OWN - NLM
STAT- MEDLINE
DCOM- 20200616
LR  - 20200616
IS  - 1365-2230 (Electronic)
IS  - 0307-6938 (Print)
IS  - 0307-6938 (Linking)
VI  - 45
IP  - 3
DP  - 2020 Apr
TI  - Efficacy and safety of HAT1 compared with calcipotriol in the treatment of 
      patients with mild to moderate chronic plaque psoriasis: results from an 
      open-label randomized comparative pilot clinical study.
PG  - 318-322
LID - 10.1111/ced.14074 [doi]
AB  - Psoriasis is commonly treated with topical corticosteroids, oral cytotoxic drugs 
      and biologic agents, which can be associated with significant adverse effects 
      (AEs), high cost and response attenuation. Additionally, patients often use 
      alternative therapies ad hoc, which can be challenging to integrate into a 
      treatment regimen, owing to a lack of adequately powered controlled trials 
      assessing efficacy and safety. We developed a novel topical botanical complex, 
      herbal anti-inflammatory treatment (HAT1), through extensive preclinical in vitro 
      and in vivo modelling to define key mechanisms of action and clinical potential. 
      To assess the efficacy and safety of HAT1 in psoriasis, we performed a 10-week, 
      open-label, pilot clinical trial comparing topical treatment of HAT1 with 
      calcipotriol 0.005% in adult patients with mild to moderate psoriasis. Primary 
      and secondary endpoints included the percentage of patients obtaining improvement 
      of >/= 75% in Psoriasis Area and Severity Index (PASI 75), Physician's Global 
      Assessment (PGA) response, and evaluation of tolerability and safety of HAT1. In 
      the HAT1 arm, 85.7% of study patients reached PASI 75 compared with 21.4% in the 
      calcipotriol comparator group. Additionally, 78.6% of patients in the HAT1 arm 
      achieved a 'clear' or 'minimal' PGA response. HAT1 was well tolerated, with no 
      AEs observed throughout the trial. These results suggest that HAT1 reduces 
      psoriasis disease activity in a clinically relevant manner. Ongoing studies, 
      including well-powered, double-blind, randomized controlled trials will be 
      required to assess the potential of HAT1 in psoriasis.
CI  - (c) 2019 Haus Bioceuticals. Clinical and Experimental Dermatology published by John 
      Wiley & Sons Ltd on behalf of British Association of Dermatology.
FAU - Alex, P
AU  - Alex P
AD  - Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.
FAU - Williams, S
AU  - Williams S
AD  - Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.
FAU - Sutton, L
AU  - Sutton L
AD  - Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.
FAU - Yesudas, T
AU  - Yesudas T
AD  - Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.
FAU - Sutton, C
AU  - Sutton C
AD  - Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.
FAU - Thomas, S
AU  - Thomas S
AD  - Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.
FAU - Centola, M
AU  - Centola M
AD  - Haus Clinical Research Program, Haus Bioceuticals, Oklahoma City, OK, USA.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20190926
PL  - England
TA  - Clin Exp Dermatol
JT  - Clinical and experimental dermatology
JID - 7606847
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Dermatologic Agents)
RN  - 0 (Plant Extracts)
RN  - 143NQ3779B (calcipotriene)
RN  - FXC9231JVH (Calcitriol)
SB  - IM
MH  - Administration, Topical
MH  - Adolescent
MH  - Adult
MH  - Anti-Inflammatory Agents/adverse effects/*therapeutic use
MH  - Calcitriol/adverse effects/*analogs & derivatives/therapeutic use
MH  - Child
MH  - Chronic Disease
MH  - Dermatologic Agents/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Plant Extracts/adverse effects/*therapeutic use
MH  - Psoriasis/*drug therapy
MH  - Young Adult
PMC - PMC7154690
EDAT- 2019/08/17 06:00
MHDA- 2020/06/17 06:00
PMCR- 2020/04/14
CRDT- 2019/08/17 06:00
PHST- 2018/01/15 00:00 [received]
PHST- 2019/07/25 00:00 [revised]
PHST- 2019/08/13 00:00 [accepted]
PHST- 2019/08/17 06:00 [pubmed]
PHST- 2020/06/17 06:00 [medline]
PHST- 2019/08/17 06:00 [entrez]
PHST- 2020/04/14 00:00 [pmc-release]
AID - CED14074 [pii]
AID - 10.1111/ced.14074 [doi]
PST - ppublish
SO  - Clin Exp Dermatol. 2020 Apr;45(3):318-322. doi: 10.1111/ced.14074. Epub 2019 Sep 
      26.