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. 2013 Mar 28;2013(3):CD005028. doi: 10.1002/14651858.CD005028.pub3

Cook‐Bolden 2010.

Methods DESIGN 
 Between‐patient
 Participant delivery
 ALLOCATION 
 Random
 Method of randomisation: unclear
 Concealment: unclear
 BLINDING 
 Double‐blind (participant/investigator)
 WITHDRAWAL/DROPOUT 
 Described
Participants N: 81
 Treatment duration: 4 wks; FU: 4 wks
 LF: 3 (4%)
 BC: yes
 Age: 43.7 (14.69SD)
 Ethnicity (% white): 78%
 Gender (per cent men): 39.5%
 Duration (yrs): 11.1 (10.5SD)
Severity: GSS = 3 (moderate) (67.9%); GSS = 4 (severe) (32.1%)
INCLUSION CRITERIA

  • People aged 18 or over with moderate to severe plaque psoriasis of the scalp (GSS = 3 or GSS = 4)


EXCLUSION CRITERIA

  • Use of chemical hair process, steroid medication, ultraviolet B (UVB) treatment, or both; calcipotriene; other vitamin D analogues; anthralin/tar; all other anti‐psoriasis medications (previous 2 wks)

  • Use of PUVA or other non‐biological systemic treatments (previous 4 wks)

  • Use of biological therapies (previous 12 wks)

  • Pregnancy or risk thereof

  • Lactation
Interventions

  • Clobetasol propionate spray 0.05% BD (CP)

  • Placebo (vehicle) spray BD (P)


Max usage/wk: 50 g
Participants achieving GSS = 0 at 2 wks completed ("withdrew" from) the study.
Outcomes

  1. Global Severity Score (GSS) (6‐pt: 0 = none to 5 = very severe), dichotomised as success (clear/almost clear) and failure

  2. Scalp psoriasis sign scores: erythema, scaling, elevation (0 to 4, where 0 = none)

  3. Pruritus (4‐pt: 0 = no itching to 3 = intense itching that disrupts sleep)

  4. Atrophy (0 to 3, where 0 = none)

  5. Telangiectasias (0 to 3, where 0 = none)

  6. Stinging/burning (0 to 3, where 0 = none)

  7. Patient satisfaction with applicator

  8. Scalpdex, a scalp dermatitis‐specific quality of life instrument; 23 questions, each scored 0 (never) to 100 (all the time)

  9. Compliance: yes if participant achieved 80% to 120% of expected applications
Notes Galderma Laboratories, LP, sponsored the trial.
Galderma supplied safety data for this study.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk The trial reported insufficient details.
Blinding (performance bias and detection bias) 
 All outcomes Low risk The trial was double‐blind (participant/investigator).
Randomisation method reported Unclear risk The trial did not report this.
Loss to follow up Low risk 4%
Baseline assessments Low risk These were made.
Baseline comparability demonstrated Low risk The trial demonstrated demographic and clinical comparability.