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NCT03665584 · ClinicalTrials.gov registry record · NA
MonaLisa Touch Laser for the Treatment of Vulvar Lichen Sclerosus
A NA study of Lichen Sclerosus, sponsored by Center for Vulvovaginal Disorders.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03665584 is a NA study of Lichen Sclerosus that has completed, run by Center for Vulvovaginal Disorders. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03665584, a NA study of Lichen Sclerosus, has completed, sponsored by Center for Vulvovaginal Disorders.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop vulvar cancer. The current "gold standard" treatment for lichen sclerosus is potent steroids creams. When used correctly, steroid creams help to decrease the symptoms of itching and burning and can prevent further vulvar scarring. In addition, proper treatment reverses the underlying inflammation of LS, and may lower the risk of getting cancer. While useful, steroid creams may have serious side effects that include thinning of the skin, fungal infections, and lowering the immune system. Recently, microablative fractional CO 2 laser treatment (FxCO 2 ) (SmartXide 2 V 2 LR laser system, for MonaLisa Touch, DEKA, Florence, Italy) has been proposed for the management of LS. Specifically, two small studies demonstrated that FxCO 2 therapy appears to be a promising treatment modality to treat lichen sclerosus. These studies demonstrated that FxCO 2 treatment may stimulate tissue healing in LS. Furthermore, by reducing inflammation, the clinical symptoms of LS, such as intense itching and burning, were improved. While these studies showed good success, these studies were limited because of their small size and lack of sham (fake treatment) control. The purpose of this study is to look at the efficacy (how well it works) and the safety of the FxCO 2 laser treatment (laser energy emitted) for LS as compared to a sham treatment (very minimal laser energy will be emitted).
Conditions Studied
Interventions
- DEVICE FxCO2 Laser
- DEVICE Sham Laser
Study Locations (1)
District of Columbia
- The Centers for Vulvovaginal Disorders - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-08-28 |
| Est. Completion | 2020-07-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03665584
The ClinicalTrials.gov registry entry for NCT03665584 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Center for Vulvovaginal Disorders, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lichen Sclerosus appearing as the primary indexed condition, and to 2 interventions - of which FxCO2 Laser is the first listed.
NCT03665584 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.
Frequently Asked Questions
What is clinical trial NCT03665584 about?
NCT03665584 is a clinical study titled "MonaLisa Touch Laser for the Treatment of Vulvar Lichen Sclerosus". Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop vulvar cancer. The curren...
What is the current status of trial NCT03665584?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2018-08-28. Estimated completion is 2020-07-14.
What conditions does trial NCT03665584 study?
This clinical trial studies the following conditions: Lichen Sclerosus.
What interventions are being tested in trial NCT03665584?
The interventions under investigation include: FxCO2 Laser (DEVICE), Sham Laser (DEVICE).
Who is sponsoring clinical trial NCT03665584?
This trial is sponsored by Center for Vulvovaginal Disorders, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03665584 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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