Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04951206 · ClinicalTrials.gov registry record · Phase 4
Fractionated CO2 Laser With and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus
A Phase 4 study, sponsored by Medstar Health Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 212
- Enrollment target
NCT04951206 is a Phase 4 study that has completed, run by Medstar Health Research Institute. The registered enrollment target is 212 participants.
The verdict
NCT04951206, a Phase 4 study, has completed, sponsored by Medstar Health Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 212 participants
- Enrollment target
Study Summary
This is a randomized placebo-controlled trial design to determine whether combining FxCO2-laser with the traditional therapy of clobetasol propionate 0.05% ointment (combined treatment) as compared to FxCO2-laser and placebo ointment (FxCO2-laser only) will improve treatment response in women undergoing FxCO2-laser for vulvar lichen sclerosus. Primary objective: To evaluate if women with LS who undergo FxCO2 laser therapy and concomitant TCS (clobetasol group) have higher treatment success (defined as a MCID of a ≥16 point improvement in Skindex-29 questionnaire) than those who undergo FxCO2 laser and placebo ointment (placebo group). * Hypothesis: A higher proportion of women randomized to clobetasol will achieve treatment success as compared to those randomized to placebo. * Approach: The proportion of women in each cohort who obtain a ≥16 point improvement in Skindex-29 validated questionnaire score from baseline to final visit will be compared. Secondary objectives: To compare change in pre- and post-treatment scores on validated questionnaires measuring vulvovaginal symptoms, sexual function, lower urinary tract function, and genital self-image between the clobetasol group compared to the placebo group. * Hypothesis: Women randomized to clobetasol will demonstrate an equal or greater improvement on validated quality of life questionnaires measuring vulvovaginal symptoms, sexual function, lower urinary tract function, and genital self-image as compared to women randomized to placebo. * Approach: Change scores will be calculated to determine change per participant over the treatment period and mean change scores will be compared between cohorts.
Interventions
- DEVICE Fractionated CO2-laser
- DRUG Clobetasol Propionate 0.05% Ointment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2022-03-01 |
| Est. Completion | 2025-04-25 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04951206
The ClinicalTrials.gov registry entry for NCT04951206 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medstar Health Research Institute, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fractionated CO2-laser is the first listed.
NCT04951206 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04951206 about?
NCT04951206 is a clinical study titled "Fractionated CO2 Laser With and Without Clobetasol for Treatment of Vulvar Lichen Sclerosus". This is a randomized placebo-controlled trial design to determine whether combining FxCO2-laser with the traditional therapy of clobetasol propionate 0.05% ointment (combined treatment) as compared to FxCO2-laser and placebo ointment (FxCO2-laser only) will improve treatment response in women underg...
What is the current status of trial NCT04951206?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 212 participants. The study started on 2022-03-01. Estimated completion is 2025-04-25.
What interventions are being tested in trial NCT04951206?
The interventions under investigation include: Fractionated CO2-laser (DEVICE), Clobetasol Propionate 0.05% Ointment (DRUG).
Who is sponsoring clinical trial NCT04951206?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.