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).


OBJECTIVE
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.
Jemec
G B E
GB
Department of Dermatology, Health Sciences Faculty, University of Copenhagen, Roskilde Hospital, Roskilde, Denmark. gbj@regionsjaelland.dk
Ullman
S
S
Goodfield
M
M
Bygum
A
A
Olesen
A B
AB
Berth-Jones
J
J
Nyberg
F
F
Cramers
M
M
Faergemann
J
J
Andersen
P
P
Kuhn
A
A
Ruzicka
T
T
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008179:Lupus Erythematosus, Discoid / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011537:Pruritus / Q000188:drug therapy* / Q000523:psychology; D012869:Skin Absorption; D013237:Stereoisomerism; D016896:Treatment Outcome
D000420:Albuterol