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Week 4
Clear
Almost
clear
15 (25%)
0 (0%)
18 (30%)
0 (0%)
32 (53%)
2 (3%)
31 (52%)
1 (2%)
Scalp psoriasis (Moderate to Severe)
FDA Labeled Indication
a) Overview
FDA Approval: Adult, yes (foam, scalp solution, shampoo);
Pediatric, yes (age 12 years or older (scalp solution, Olux(R) foam))
Efficacy: Adult, Evidence favors efficacy
Recommendation: Adult, Class IIb
Strength of Evidence: Adult, Category B
See Drug Consult reference:
RECOMMENDATION AND EVIDENCE RATINGS
b) Summary:
Clobetasol propionate shampoo is indicated for the treatment of
moderate to severe forms of scalp psoriasis in patients 18 years of
age and older
[44]
c) Adult:
1) Safety and efficacy of clobetasol shampoo was demonstrated in 2
separate clinical trials involving a total of 290 patients with moderate
to severe scalp psoriasis . In both trials, patients were treated with
clobetasol propionate shampoo 0.05% or a corresponding vehicle
once daily for 15 minutes over a period of 4 weeks. Success rates,
defined as the proportion of patients with a 0 (clear) or 1 (minimal)
on a 0 to 5 point physician's Global Severity Scale for scalp
psoriasis, were 42% and 28% in the groups using clobetasol
compared to 2% and 10% in the groups using shampoo vehicle.
The percentage of patients with 0 (clear) on a 0 to 3-point scalp
psoriasis parameter scale for parameters of erythema, scaling, and
plaque thickening at the end of both studies were:
PARAMETER
Erythema
Scaling
Plaque Thickening
CLOBETASOL SHAMPOO
18% and 12%
22% and 15%
37% and 34%
PLACEBO
6% and 2%
0% and 4%
11% and 10%