A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus

G B E Jemec; S Ullman; M Goodfield; A Bygum; A B Olesen; J Berth-Jones; F Nyberg; M Cramers; J Faergemann; P Andersen; A Kuhn; T Ruzicka

doi:10.1111/j.1365-2133.2009.09330.x

A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus

G B E Jemec, S Ullman, M Goodfield, A Bygum, A B Olesen, J Berth-Jones, F Nyberg, M Cramers, J Faergemann, P Andersen, A Kuhn, T Ruzicka

Department of Immunology and Microbiology

42 Citations (Scopus)

Abstract

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.

Original language	English
Journal	British Journal of Dermatology
Volume	161
Issue number	6
Pages (from-to)	1365-70
Number of pages	6
ISSN	0007-0963
DOIs	https://doi.org/10.1111/j.1365-2133.2009.09330.x
Publication status	Published - 2009

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Jemec, G. B. E., Ullman, S., Goodfield, M., Bygum, A., Olesen, A. B., Berth-Jones, J., Nyberg, F., Cramers, M., Faergemann, J., Andersen, P., Kuhn, A., & Ruzicka, T. (2009). A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus. British Journal of Dermatology, 161(6), 1365-70. https://doi.org/10.1111/j.1365-2133.2009.09330.x

@article{e51f8cd0747511df928f000ea68e967b,

title = "A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus",

abstract = "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.",

author = "Jemec, {G B E} and S Ullman and M Goodfield and A Bygum and Olesen, {A B} and J Berth-Jones and F Nyberg and M Cramers and J Faergemann and P Andersen and A Kuhn and T Ruzicka",

note = "Keywords: Administration, Topical; Adult; Aged; Albuterol; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Lupus Erythematosus, Discoid; Male; Middle Aged; Patient Satisfaction; Pruritus; Skin Absorption; Stereoisomerism; Treatment Outcome",

year = "2009",

doi = "10.1111/j.1365-2133.2009.09330.x",

language = "English",

volume = "161",

pages = "1365--70",

journal = "British Journal of Dermatology",

issn = "0007-0963",

publisher = "Wiley-Blackwell",

number = "6",

}

TY - JOUR

T1 - A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus

AU - Jemec, G B E

AU - Ullman, S

AU - Goodfield, M

AU - Bygum, A

AU - Olesen, A B

AU - Berth-Jones, J

AU - Nyberg, F

AU - Cramers, M

AU - Faergemann, J

AU - Andersen, P

AU - Kuhn, A

AU - Ruzicka, T

N1 - Keywords: Administration, Topical; Adult; Aged; Albuterol; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Lupus Erythematosus, Discoid; Male; Middle Aged; Patient Satisfaction; Pruritus; Skin Absorption; Stereoisomerism; Treatment Outcome

PY - 2009

Y1 - 2009

N2 - 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.

AB - 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.

U2 - 10.1111/j.1365-2133.2009.09330.x

DO - 10.1111/j.1365-2133.2009.09330.x

M3 - Journal article

C2 - 19681862

SN - 0007-0963

VL - 161

SP - 1365

EP - 1370

JO - British Journal of Dermatology

JF - British Journal of Dermatology

IS - 6

ER -

A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus

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