Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

NCT01126255 | Terminated Phase 2

• 1 other identifier: 213/08
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.

Conditions

Vulvar Lichen Sclerosus

Keywords

vulvar lichen sclerosus; progesterone; clobetasol; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Score of the characteristics of Lichen sclerosus based on vulvar efflorescences

  The severity of the Lichen sclerosus will be assessed by a metric score, which is based on 6 items (abrasion, hyperkeratosis, rhagades, synechia, sclerosis, atrophy of labia/clitoris) consisting of three levels (0=no signs, 1=few signs, 2=pronounced signs).

  at 12 weeks

Secondary Outcomes (11)

• Patient-reported symptoms

  at baseline

• Quality of life

  at baseline

• Adverse events

  at baseline

• Patient-reported symptoms

  at 6 weeks

• Patient-reported symptoms

  at 12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks

Drug: Clobetasol propionate 0.05%

2

EXPERIMENTAL

Progesterone 8%, topical application, once daily about 2 g, during 12 weeks

Drug: Progesterone 8%

Interventions

Clobetasol propionate 0.05% DRUG

Topical application, once daily about 2 g, during 12 weeks

1

Progesterone 8% DRUG

Topical application, once daily about 2 g, during 12 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Consent to biopsy at start and end of therapy
• Suspicion of Lichen sclerosus
• Pre-menopausal
• Age ≥18 years

You may not qualify if:

• Prior surgery at the vulva, with exception of episiotomy
• Pregnancy
• Signs of infection with human papilloma virus at the vulva
• Vulvar intraepithelial neoplasia (VIN)
• Known generalised autoimmune disease
• Lichen sclerosus since childhood
• Prior therapy with topic clobetasol propionate or other immunosuppressives (tacrolimus or pimecrolimus) at the vulva
• Atopic diathesis and/or contact allergy
• Systemic immunosuppressive therapy
• Genital infection within the last four weeks (eg., condyloma acuminata, candidiasis)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Dep. of Obstetrics and Gynecology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (1)

• Gunthert AR, Limacher A, Beltraminelli H, Krause E, Mueller MD, Trelle S, Bobos P, Juni P. Efficacy of topical progesterone versus topical clobetasol propionate in patients with vulvar Lichen sclerosus - A double-blind randomized phase II pilot study. Eur J Obstet Gynecol Reprod Biol. 2022 May;272:88-95. doi: 10.1016/j.ejogrb.2022.03.020. Epub 2022 Mar 10.

  PMID: 35290878 RESULT

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Andreas Guenthert, Prof. Dr. med.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 19, 2010
• Study Start: March 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

CH (1)