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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: Completed Phase 4 study, sponsored by Medstar Health Research Institute.
NCT04951206 is a Phase 4 study that has completed, run by Medstar Health Research Institute. The registered enrollment target is 212 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Minimally clinically important difference of a ≥16 point improvement in Skindex-29 validated questionnaire score. Skindex-29 responses are transformed to a linear scale from 0 (no effect) to 100 (effect experienced all the time), and are reported as three scale scores, corresponding to three domains (symptoms, emotions, and functioning). A reduction in Skindex-29 score of 16 points or more has been shown to indicate what is considered a clinically meaningful improvement.
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 |
What the finished NCT04951206 record still lists
NCT04951206 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Fractionated CO2-laser is the first listed.
NCT04951206 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04951206's enrollment target sits among peer trials
212 396th of 2000 higher than 1,603 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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