title: Effective symptomatic treatment for severe and intractable pruritus associated with severe burn-induced hypertrophic scars: A prospective, multicenter, controlled trial.
abstract: BACKGROUND
  Burn-induced hypertrophic scars are disfiguring and can be associated with severe and intractable pruritus. No effective treatment modalities are currently available for symptomatic control of pruritus for most patients. We assessed the effect of the Antipruritic Hydrogel (CQ-01) in the symptomatic treatment of severe and intractable pruritus associated with burn-induced hypertrophic scars in a prospective, multicenter, controlled trial.
  
  
  METHODS
  A pilot study was conducted in healthy adult volunteers to identify the most appropriate hydrogel formulation. A selected preparation called Chongqing No. 1 (CQ-01; a guar gum-based hydrogel impregnated with peppermint oil, menthol, and methyl salicylate by a nanoemulsion), showed an excellent symptomatic relief in an exploratory study in 2 patients with intractable pruritus. A statistically powered, prospective, multicenter, controlled study was then conducted in 74 patients to evaluate the efficacy and safety of a 24-h application of CQ-01 compared to a gel control and a negative control on three separate areas in each patient. Symptom assessment was based on our visual analog JW scale (ranging from 0 to 100) at baseline and various time points up to 7 days after application. Follow-up studies were conducted to determine the reproducibility of CQ-01 in repeated applications.
  
  
  RESULTS
  Of the 74 enrolled subjects, the only observed adverse event was skin irritation reported in 6 patients (8%) and resolved shortly after gel removal. Compared to the baseline, the gauze negative control had a mean JW score reduction of 7; while the gel control and CQ-01 had a drop of 18 (p<0.001) and 36 (p<0.001), respectively. The CQ-01 clinical effect was significant for up to 3 days and waned slowly from 3 to 7 days. There was no statistical correlation between the treatment response and any of the demographic, patient or burn-related factors. Further studies showed a trend that repeated applications might be more effective, suggesting the absence of tachyphylaxis.
  
  
  CONCLUSIONS
  This prospective, multicenter, controlled study showed that this novel hydrogel CQ-01 is safe and provides significant symptomatic relief for severe and intractable pruritus associated with hypertrophic scars, an unmet medical need for these patients. This effect is independent of the etiology of the burn trauma, extent of the scarring, and duration of the scar formation.
authors.affiliation: Institute of Burn Research, State Key Laboratory of Trauma, Burns and Combined Injuries, Chongqing Key Laboratory for Disease Proteomics, Southwest Hospital, Third Military Medical University, Chongqing 400038, China. Electronic address: jun.wu@burnstrauma.com.
authors.forename: Jun
authors.initials: J
authors.lastname: Wu
authors.affiliation: Institute of Burn Research, State Key Laboratory of Trauma, Burns and Combined Injuries, Chongqing Key Laboratory for Disease Proteomics, Southwest Hospital, Third Military Medical University, Chongqing 400038, China.
authors.forename: Rui
authors.initials: R
authors.lastname: Xu
authors.affiliation: Institute of Burn Research, State Key Laboratory of Trauma, Burns and Combined Injuries, Chongqing Key Laboratory for Disease Proteomics, Southwest Hospital, Third Military Medical University, Chongqing 400038, China.
authors.forename: Rixing
authors.initials: R
authors.lastname: Zhan
authors.affiliation: Institute of Burn Research, State Key Laboratory of Trauma, Burns and Combined Injuries, Chongqing Key Laboratory for Disease Proteomics, Southwest Hospital, Third Military Medical University, Chongqing 400038, China.
authors.forename: Gaoxing
authors.initials: G
authors.lastname: Luo
authors.affiliation: Department of Burn, Zhengzhou First People's Hospital, Zhengzhou 450000, China.
authors.forename: Xihua
authors.initials: X
authors.lastname: Niu
authors.affiliation: Lanzhou General Hospital, Lanzhou Command of China People's Liberation Army, Lanzhou, Gansu 730050, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Liu
authors.affiliation: MJ Medical Gel Systems Ltd., No. 6 Science Park West Avenue, Hong Kong Science Park, Shatin, Hong Kong SAR, China; PolyGum Technologies Ltd., Hong Kong Science Park, Shatin, Hong Kong SAR, China.
authors.forename: Benjamin Tak-Kwong
authors.initials: BT
authors.lastname: Lee
authors.affiliation: PolyGum Technologies Ltd., Hong Kong Science Park, Shatin, Hong Kong SAR, China.
authors.forename: Meinrad
authors.initials: M
authors.lastname: Flury
authors.affiliation: MJ Medical Gel Systems Ltd., No. 6 Science Park West Avenue, Hong Kong Science Park, Shatin, Hong Kong SAR, China; PolyGum Technologies Ltd., Hong Kong Science Park, Shatin, Hong Kong SAR, China.
authors.forename: Chun-Ho
authors.initials: CH
authors.lastname: Wong
authors.affiliation: MJ Medical Gel Systems Ltd., No. 6 Science Park West Avenue, Hong Kong Science Park, Shatin, Hong Kong SAR, China; Faculty of Health Sciences, Macau University of Science and Technology, Avenida Wai Long, Cotai, Macau SAR, China.
authors.forename: Manson
authors.initials: M
authors.lastname: Fok
authors.affiliation: Institute of Burn Research, State Key Laboratory of Trauma, Burns and Combined Injuries, Chongqing Key Laboratory for Disease Proteomics, Southwest Hospital, Third Military Medical University, Chongqing 400038, China; MJ Medical Gel Systems Ltd., No. 6 Science Park West Avenue, Hong Kong Science Park, Shatin, Hong Kong SAR, China; Department of Applied Biology and Chemical Technology, Hong Kong Polytechnic University, Hung Hom, Hong Kong SAR, China.
authors.forename: Johnson Yiu-Nam
authors.initials: JY
authors.lastname: Lau
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000982:Antipruritics / Q000009:adverse effects / Q000627:therapeutic use*; D002056:Burns / Q000150:complications*; D017439:Cicatrix, Hypertrophic / Q000150:complications*; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D020100:Hydrogels / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D011537:Pruritus / Q000209:etiology / Q000628:therapy*; D015203:Reproducibility of Results; D055815:Young Adult
chemical_list: D000982:Antipruritics; D004365:Drugs, Chinese Herbal; D020100:Hydrogels; D010936:Plant Extracts
keywords: Burn; Hydrogel; Hypertrophic scars; ITT; PP; Pruritus