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. 2016 Nov 16;2016(11):CD008320. doi: 10.1002/14651858.CD008320.pub3

Young 2009.

Methods RCT
Vehicle‐controlled
Parallel‐group design
Participants Pruritus: UP       
Description: participants with ESRD on haemodialysis
Number of participants randomised: 28
  • 1% pramoxine HCl lotion: 14

  • Cetapil lotion: 14


Number of participants evaluable: 27
  • 1% pramoxine HCl lotion: 13

  • Cetapil lotion: 14


Withdrawals/dropouts: 1
Reason for dropout: unrelated subject death
Age (range): 18‐70 years
Sex (male/female): 14/14
Underlying disease(s): ESRD
Participant pool: single‐centre
Setting: inpatient
Haemodialysis: at least 3 months
Baseline pruritus assessment: yes
Duration/severity of pruritus: symptoms of itch in a regular pattern over 6 months; at least 2 episodes of itch > 2 minutes within 2 weeks
Baseline parameters: (mean ± SD)
  • Pruritus relief (measured by VAS 10 cm): 5.5 (no SD)

  • Quality of life (measured by Investigator Global Assessment, 0‐6, higher values = worse): 4.11 ± 1.13

  • Burning/stinging (measured by scale 1‐3): 0.14 ± 0.45

Interventions
  • Intervention 1: pramoxine HCl (1%)

  • Intervention 2: mousterizing lotion (Cetaphil)


Additional medication: no information
Route of administration: topical to all affected areas of pruritus/2x daily
Duration of treatment: 4 weeks
Follow‐up: baseline ‐ week 1‐ week 4
Outcomes Pruritus assessment: VAS 10 cm
Adverse events
Additional outcomes:
  • Erythaema, xerosis, and lichenification (assessed by a 3‐point‐Likert scale with '0' indication no symptoms and with '3' representing severe)

  • Indidvidual pruritus history and assessment questionnaire

  • Investigator Global Assessment (IGA) of response to treatment

  • Skin hydration measurements using the MoistureMeter pico

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomised; method not stated
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind; unclear who was blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information provided
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk One participant lost because of unrelated subject death; not reported if intention‐to‐treat analysis
Selective reporting (reporting bias) Unclear risk Inclusion and exclusion criteria inadequately described; insufficient data on pruritus VAS (no confidence interval, only graphical illustration)
Size of study (possible biases confounded by small size) High risk Number of participants randomised: 28
Other bias Unclear risk Assessment of compliance not stated; possible carryover effect not mentioned