Efficacy of topical progesterone versus topical clobetasol propionate in patients with vulvar Lichen sclerosus - A double-blind randomized phase II pilot study.

Günthert, Andreas R; Limacher, Andreas; Beltraminelli, Helmut; Krause, Elke; Mueller, Michael D; Trelle, Sven; Bobos, Pavlos; Jüni, Peter (2022). Efficacy of topical progesterone versus topical clobetasol propionate in patients with vulvar Lichen sclerosus - A double-blind randomized phase II pilot study. European journal of obstetrics & gynecology and reproductive biology, 272, pp. 88-95. Elsevier 10.1016/j.ejogrb.2022.03.020

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BACKGROUND

Lichen sclerosus (LS) is a chronic inflammatory skin disease that mostly affects the anogenital region of women and lowers patients' quality of life. Current standard treatment of LS is topical steroids.

OBJECTIVE

To evaluate the efficacy of topical progesterone 8% ointment and compare to standard therapy with topical clobetasol propionate 0.05% in premenopausal women presenting with previously untreated early onset LS.

STUDY DESIGN

Randomized, double-blind, 2-arm, single center superiority trial in premenopausal women with histologically confirmed vulvar LS who were randomized in a 1:1 ratio to receive clobetasol propionate 0.05% ointment or progesterone 8% ointment. The primary outcome was the clinical severity LS score after 12 weeks, which consists of six clinical features assessed by the physician. Secondary outcomes were the symptom severity LS score, which consists of three symptoms rated by the patient, the Short Form SF-12 physical and mental health scores, and adverse events. Response to medication was assessed by biopsy at the end of the treatment to evaluate inflammatory parameters.

RESULTS

Overall, 105 women were screened, 102 underwent vulvar biopsy and 37 received a histologically confirmed diagnosis of LS and were randomized: 17 to progesterone and 20 to clobetasol propionate. At 12 weeks, the mean clinical LS scores improved from 4.6 (SD 2.0) to 4.5 (SD 1.7) in the progesterone arm, and from 4.6 (SD 2.8) to 2.9 (SD 2.2) in the clobetasol propionate arm (difference in favor of clobetasol 1.61; 95% CI 0.44 to 2.77, p = 0.009), and the mean symptom severity LS scores improved from 4.5 (SD 3.8) to 3.1 (SD 3.0) in the progesterone arm, and from 4.7 (SD 2.8) to 1.9 (SD 1.8) in the clobetasol propionate arm (difference in favor of clobetasol 1.32; 95% CI -0.25 to 2.89, p = 0.095). LS was in complete remission in 6 out of 10 patients (60%) with available biopsy in the progesterone arm, and in 13 out of 16 patients (81.3%) in the clobetasol propionate arm (odds ratio in favor of clobetasol 0.35; 95% CI 0.06 to 2.06, p = 0.234). No drug-related serious adverse event occurred during the trial.

CONCLUSIONS

Topical progesterone 8% ointment is inferior to standard therapy with topical clobetasol propionate 0.05% in previously untreated premenopausal women with vulvar LS after 12 weeks treatment.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Gynaecology
04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Dermatology
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern

UniBE Contributor:

Günthert, Andreas Reinhold; Limacher, Andreas; Beltraminelli, Helmut; Krause, Elke; Mueller, Michael and Trelle, Sven

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0301-2115

Publisher:

Elsevier

Funders:

[4] Swiss National Science Foundation

Language:

English

Submitter:

Pubmed Import

Date Deposited:

16 Mar 2022 12:26

Last Modified:

08 Aug 2022 14:43

Publisher DOI:

10.1016/j.ejogrb.2022.03.020

PubMed ID:

35290878

Additional Information:

Günthert and Limacher contributed equally to this work.

Uncontrolled Keywords:

Clobetasol propionate Lichen sclerosus Progesterone

BORIS DOI:

10.48350/167454

URI:

https://boris.unibe.ch/id/eprint/167454

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