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NCT04148651 · ClinicalTrials.gov registry record · NA
The CO2RE® System for Vulvar Lichen Sclerosus
A NA study, sponsored by Candela Corporation.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT04148651: Completed NA study, sponsored by Candela Corporation.
NCT04148651 is a NA study that has completed, run by Candela Corporation. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04148651, a NA study, has completed, sponsored by Candela Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2) laser treatment to the vulvar area. Subjects will be evaluated for changes in clinical signs and architectural changes associated with VLS at designated follow-ups to 1-year post treatment series.
Primary Outcome
Each clinical sign of VLS (loss of elasticity, sclerosis, lichenification, whitening, parchment-like skin, fissures, extent of the disease, erosions, ulcerations, hyperkeratosis, excoriation, telangiectasia) was assessed separately by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and follow-ups. For those clinical signs present at baseline (baseline score \>0 on severity scale), an average severity grade was calculated at eac
Interventions
- DEVICE The CO2RE® System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-07-11 |
| Est. Completion | 2020-12-17 |
| Phase | NA |
What the finished NCT04148651 record still lists
NCT04148651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which The CO2RE® System is the first listed.
NCT04148651 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04148651 about?
NCT04148651 is a clinical study titled "The CO2RE® System for Vulvar Lichen Sclerosus". Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2) laser treatment to the vulvar area. Subjects will be evaluated for changes in clinical signs and architectural changes associated with VLS at designated follow-ups to 1-year post treatment series.
What is the current status of trial NCT04148651?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2018-07-11. Estimated completion is 2020-12-17.
What interventions are being tested in trial NCT04148651?
The interventions under investigation include: The CO2RE® System (DEVICE).
Who is sponsoring clinical trial NCT04148651?
This trial is sponsored by Candela Corporation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04148651's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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