Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKantonsspital Winterthur KSW

About this trial

With this trial the investigators look for the effect of Laser maintenance therapy in patients with vulvar lichen sclerosus compared to the maintenance standard treatment clobetasol propionate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pre- or postmenopausal

12 weeks of continuous topical clobetasol treatment completed.

Written informed consent

German speaking (Study information and IC available only in German)

Disqualifiers

Contraindication and limitations for the use of Mona Lisa Glide-Laser as described in the instructions for use

Contraindication for the use of topic clobetasol

History of vulva laser

Immune-suppression

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treatment with Monalisa Glide Laser

    Device

    3 fractional laser treatment-sessions with Monalisa Glide

  • Treatment with Clobetasol

    Drug

    Application of Clobetasol twice per week

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Laser groupExperimental treatment 1 intervention
Group B: Clobetasol groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Lichen Score

The difference between the initial Lichen score and the score at 3 month after treatment start = 1 month after EOT

Time frame
3 months

Secondary outcomes

1

Lichen Score Follow up

Lichen score at 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms)

Time frame
15 months
2

Vulva assessment Scale

Vulva assessment scale at 1, 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms)

Time frame
15 months
3

German Pelvic floor questionnaire

Shortened Pelvic floor questionnaire at 1, 4, 8, 12 months after EOT

Time frame
15 months

Other outcomes

Sponsors and contacts

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