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

Sponsor
Kantonsspital Winterthur KSW (Other)
Overall Status
Recruiting
CT.gov ID
NCT06135402
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
35.7
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Treatment with Monalisa Glide Laser
  • Drug: Treatment with Clobetasol
 N/A

Detailed Description

Vulvar Lichen sclerosus (VLS) is a chronic inflammatory cutaneous disorder, which can lead to scarring, impaired sexual function and malignancy. Gold standard treatment is topical corticosteroids (TCS) initially daily for 12 weeks. To avoid new flourishing of the disease a life-long maintenance treatment 2x/week is later recommended. Fractional CO2-Laser has shown a positive effect on vulvovaginal skin quality with improvement of urogenital atrophy and also lichen sclerosus. This randomised trial compares efficacy of laser treatment to TCS maintenance as well as the duration of the laser effect.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Monocentric, prospective, randomized, single-blinded, active-controlledMonocentric, prospective, randomized, single-blinded, active-controlled
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Monocentric, Prospective, Randomised, Single Blinded, Active-controlled Trial to Prove That the Treatment With Monalisa Glide is Equal to Topic Clobetasol Propionate Maintenance Therapy in Vulvar Lichen Sclerosus
Actual Study Start Date :
Nov 10, 2023
Anticipated Primary Completion Date :
Nov 1, 2026
Anticipated Study Completion Date :
Nov 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Laser group

3 monthly fractional laser treatment according to the user manual (correct applicator, vulvar and vaginal preset). In between daily local skin care with a drug free product of patients' choice.

Device: Treatment with Monalisa Glide Laser
3 fractional laser treatment-sessions with Monalisa Glide
Active Comparator: Clobetasol group

Maintenance treatment with vulvar TCS (clobetasol) application 2x/week. Instruction given at trial start and monthly check up for treatment control Daily local skin care with a drug free product of patients' choice.

Drug: Treatment with Clobetasol
Application of Clobetasol twice per week

Outcome Measures

Primary Outcome Measures

  1. Lichen Score [3 months]

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

Secondary Outcome Measures

  1. Lichen Score Follow up [15 months]

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

  2. Vulva assessment Scale [15 months]

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

  3. German Pelvic floor questionnaire [15 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Pre- or postmenopausal

  • 12 weeks of continuous topical clobetasol treatment completed.

  • Written informed consent

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

Exclusion Criteria:

  • 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

  • Pregnancy or planned pregnancy, breast feeding.

  • Clinically significant concomitant diseases states as severe renal failure, hepatic dysfunction, severe cardiovascular disease, cancer.

  • History of vulvar or pelvic radiation therapy

  • Uncertain vulvar findings, which require a biopsy.

  • Acute vulvitis, especially recurrent genital herpes

  • History of vaginal mesh implantation within 6 months preceding this study

  • Known or suspected non-compliance, drug or alcohol abuse

  • Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject

  • Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation

  • Previous enrolment into the current investigation

  • Enrolment of the PI, his/her family members, employees and other dependent persons

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kantonsspital Winterthur Winterthur Zürich Switzerland 8401

Sponsors and Collaborators

  • Kantonsspital Winterthur KSW

Investigators

  • Principal Investigator: Gesine Meili, MD, Clinic of obstetrics and gynecology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier:
NCT06135402
Other Study ID Numbers:
  • Laser-Lichen
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lichen Sclerosus et Atrophicus
Clobetasol

Study Results

No Results Posted as of Nov 18, 2023