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

Autor: Günthert AR; Department of Gynecology and Obstetrics, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland; gyn-zentrum ag, Lucerne, Switzerland., Limacher A; CTU Bern, University of Bern, Bern, Switzerland. Electronic address: andreas.limacher@ctu.unibe.ch., Beltraminelli H; Department of Dermatology and Dermatopathology, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland., Krause E; Department of Gynecology and Obstetrics, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland., Mueller MD; Department of Gynecology and Obstetrics, Inselspital, Bern University Hospital, and University of Bern, Bern, Switzerland., Trelle S; CTU Bern, University of Bern, Bern, Switzerland., Bobos P; University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Toronto, Canada., Jüni P; University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Toronto, Canada; Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.
Jazyk: angličtina
Zdroj: European journal of obstetrics, gynecology, and reproductive biology [Eur J Obstet Gynecol Reprod Biol] 2022 May; Vol. 272, pp. 88-95. Date of Electronic Publication: 2022 Mar 10.
DOI: 10.1016/j.ejogrb.2022.03.020
Abstrakt: 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.
(Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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