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Proactive maintenance therapy with a topical corticosteroid for vulvar lichen sclerosus: preliminary results of a randomized study.
Br J Dermatol. 2013 Jun; 168(6):1316-24.BJ

Abstract

BACKGROUND

The chronic and relapsing nature of vulvar lichen sclerosus (VLS) represents a challenge for its long-term management after an effective treatment with topical corticosteroids.

OBJECTIVES

To assess the effectiveness of proactive, twice-weekly application of mometasone furoate 0·1% ointment, compared with daily topical vitamin E or cold cream, in keeping VLS in remission and reducing the risk of relapse after 3 months of treatment with topical corticosteroid.

METHODS

In total, 27 patients affected with VLS were enrolled into a 12-week active treatment phase (AP) with topical mometasone furoate 0·1% ointment once daily. Those who achieved disease remission entered a 52-week maintenance phase (MP) in which patients were randomized to apply either mometasone furoate 0·1% ointment twice weekly, a cold cream once daily or topical vitamin E once daily. The primary efficacy parameters were the relapse rate and the mean time to relapse.

RESULTS

Twenty-five patients considered to have been completely or almost completely healed after the AP entered the MP. By the end of the 52-week MP, 10 patients (40%) experienced a relapse: five in the vitamin E group (56%) and five in the cold cream group (62%), while no patient in the mometasone furoate 0·1% ointment group had a relapse. The occurrence of VLS relapse for patients in therapy with both vitamin E and cold cream was significantly higher than for those in proactive therapy with topical corticosteroid. The median time to relapse was the same (21·6 weeks) for the vitamin E and the emollient groups.

CONCLUSIONS

Once VLS has been stabilized with topical corticosteroids, twice-weekly proactive application of mometasone furoate 0·1% ointment over 56 weeks was found to be an effective and safe therapy option in maintaining VLS remission and in preventing the occurrence of relapse.

Authors+Show Affiliations

Department of Clinical and Experimental Medicine, Section of Dermatology, University of Ferrara, Via Savonarola 9, 44121, Ferrara, Italy. vri@unife.itNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

23398459

Citation

Virgili, A, et al. "Proactive Maintenance Therapy With a Topical Corticosteroid for Vulvar Lichen Sclerosus: Preliminary Results of a Randomized Study." The British Journal of Dermatology, vol. 168, no. 6, 2013, pp. 1316-24.
Virgili A, Minghetti S, Borghi A, et al. Proactive maintenance therapy with a topical corticosteroid for vulvar lichen sclerosus: preliminary results of a randomized study. Br J Dermatol. 2013;168(6):1316-24.
Virgili, A., Minghetti, S., Borghi, A., & Corazza, M. (2013). Proactive maintenance therapy with a topical corticosteroid for vulvar lichen sclerosus: preliminary results of a randomized study. The British Journal of Dermatology, 168(6), 1316-24. https://doi.org/10.1111/bjd.12273
Virgili A, et al. Proactive Maintenance Therapy With a Topical Corticosteroid for Vulvar Lichen Sclerosus: Preliminary Results of a Randomized Study. Br J Dermatol. 2013;168(6):1316-24. PubMed PMID: 23398459.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Proactive maintenance therapy with a topical corticosteroid for vulvar lichen sclerosus: preliminary results of a randomized study. AU - Virgili,A, AU - Minghetti,S, AU - Borghi,A, AU - Corazza,M, PY - 2013/02/05/accepted PY - 2013/2/13/entrez PY - 2013/2/13/pubmed PY - 2014/2/28/medline SP - 1316 EP - 24 JF - The British journal of dermatology JO - Br J Dermatol VL - 168 IS - 6 N2 - BACKGROUND: The chronic and relapsing nature of vulvar lichen sclerosus (VLS) represents a challenge for its long-term management after an effective treatment with topical corticosteroids. OBJECTIVES: To assess the effectiveness of proactive, twice-weekly application of mometasone furoate 0·1% ointment, compared with daily topical vitamin E or cold cream, in keeping VLS in remission and reducing the risk of relapse after 3 months of treatment with topical corticosteroid. METHODS: In total, 27 patients affected with VLS were enrolled into a 12-week active treatment phase (AP) with topical mometasone furoate 0·1% ointment once daily. Those who achieved disease remission entered a 52-week maintenance phase (MP) in which patients were randomized to apply either mometasone furoate 0·1% ointment twice weekly, a cold cream once daily or topical vitamin E once daily. The primary efficacy parameters were the relapse rate and the mean time to relapse. RESULTS: Twenty-five patients considered to have been completely or almost completely healed after the AP entered the MP. By the end of the 52-week MP, 10 patients (40%) experienced a relapse: five in the vitamin E group (56%) and five in the cold cream group (62%), while no patient in the mometasone furoate 0·1% ointment group had a relapse. The occurrence of VLS relapse for patients in therapy with both vitamin E and cold cream was significantly higher than for those in proactive therapy with topical corticosteroid. The median time to relapse was the same (21·6 weeks) for the vitamin E and the emollient groups. CONCLUSIONS: Once VLS has been stabilized with topical corticosteroids, twice-weekly proactive application of mometasone furoate 0·1% ointment over 56 weeks was found to be an effective and safe therapy option in maintaining VLS remission and in preventing the occurrence of relapse. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/23398459/Proactive_maintenance_therapy_with_a_topical_corticosteroid_for_vulvar_lichen_sclerosus:_preliminary_results_of_a_randomized_study_ L2 - https://doi.org/10.1111/bjd.12273 DB - PRIME DP - Unbound Medicine ER -