Clobetasol Group for Vulvar Lichen Sclerosus

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Vulvar Lichen SclerosusClobetasol Propionate 0.05% Ointment - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is designed to see if the traditional therapy of clobetasol combined with FxCO2-laser therapy is more effective than just FxCO2-laser therapy alone in women with vulvar lichen sclerosus.

Eligible Conditions
  • Vulvar Lichen Sclerosus

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: About 5 months (baseline to final visit)

Month 5
Treatment response - genital self image
Urination
Treatment response - sexual function
Treatment response - vulvovaginal symptoms
Treatment success
Week 6
Participant-perceived improvement
Participant-perceived treatment satisfaction

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Clobetasol Group
1 of 2
Placebo Group
1 of 2

Active Control

Non-Treatment Group

184 Total Participants · 2 Treatment Groups

Primary Treatment: Clobetasol Group · Has Placebo Group · Phase 4

Clobetasol GroupActiveComparator Group · 2 Interventions: Clobetasol Propionate 0.05% Ointment, Fractionated CO2-laser · Intervention Types: Drug, Device
Placebo Group
Device
PlaceboComparator Group · 1 Intervention: Fractionated CO2-laser · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: about 5 months (baseline to final visit)

Who is running the clinical trial?

Society of Gynecologic SurgeonsUNKNOWN
Patty Brisben Foundation For Women's Sexual HealthOTHER
6 Previous Clinical Trials
211 Total Patients Enrolled
Medstar Health Research InstituteLead Sponsor
175 Previous Clinical Trials
133,892 Total Patients Enrolled
1 Trials studying Vulvar Lichen Sclerosus
52 Patients Enrolled for Vulvar Lichen Sclerosus

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to undergo concomitant 0.05% clobetasol propionate treatment.

Who else is applying?

What state do they live in?
Texas25.0%
Michigan25.0%
Pennsylvania25.0%
Other25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
The University of New Mexico100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
What questions have other patients asked about this trial?
  • "How long is the trial and out of pocket cost for me?"
How many prior treatments have patients received?
2100.0%
References