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document
A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus . BACKGROUND In a recent open pilot trial , R-salbutamol sulphate , a well-known molecule with anti-inflammatory effects , was tested successfully on patients with therapy-resistant discoid lupus erythematosus ( DLE ) . OBJECTIVES To compare the efficacy and safety of R-salbutamol cream 0.5 % vs. placebo on DLE lesions in a multicentre , double-blinded , randomized , placebo-controlled phase II trial . METHODS Thirty-seven patients with at least one newly developed DLE lesion were randomized - 19 to the R-salbutamol cream 0.5 % and 18 to placebo - and treated twice daily for 8 weeks . Efficacy was evaluated through scores of erythema , scaling/hypertrophy and induration as well as pain and itching ; general improvement scored by the investigator and global improvement scored by patients ' assessment were also evaluated . RESULTS The mean area under the curve of improvement for scaling/hypertrophy , pain , itching and global patient assessment was significantly better for the actively treated patients as compared with placebo ( scaling/hypertrophy , P = 0.0262 ; pain , P = 0.0238 ; itching , P = 0.0135 ; global patient assessment , P = 0.045 ) . Moreover , the percentage of patients without induration was significantly higher in the active group compared with the placebo group ( P = 0.013 ) , and a statistically significantly greater decrease in the size of the lesional area was also seen in the overall analysis of the R-salbutamol-treated patients ( P = 0.0197 ) . No serious adverse events were reported . CONCLUSIONS Application of R-salbutamol cream 0.5 % was safe and well tolerated . Statistically significant effects were seen on scaling/hypertrophy , induration , pain and itching as well as patient global assessment , suggesting that R-salbutamol could be a promising new topical therapy alternative for DLE .
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Intervention_Pharmacological
R-salbutamol
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Intervention_Pharmacological
R-salbutamol sulphate
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Intervention_Pharmacological
R-salbutamol cream
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Intervention_Control
placebo
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Intervention_Pharmacological
19 to the R-salbutamol cream 0.5 %
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Intervention_Control
placebo
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Intervention_Control
placebo
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Outcome_Other
Efficacy
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Outcome_Physical
scores of erythema
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Outcome_Physical
scaling/hypertrophy and induration
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Outcome_Pain
pain and
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Outcome_Physical
itching
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Outcome_Other
general improvement
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Outcome_Physical
scored by the investigator and global improvement scored by patients ' assessment were also evaluated
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Outcome_Physical
scaling/hypertrophy
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Outcome_Pain
pain
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Outcome_Physical
global patient assessment
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Outcome_Physical
induration
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Outcome_Physical
size of the lesional area
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Outcome_Adverse-effects
serious adverse events
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Participant_Condition
discoid lupus erythematosus .