Vulvar Lichen SclerosusPhase 2/3NCT05243563
Does Steroid Plus CO2 Laser Improve Lichen Sclerosus Symptoms Compared to Steroids Alone?
A Phase 2/3 study testing MonaLisa Touch and Topical steroid in people with Vulvar Lichen Sclerosus, run by University of South Alabama at 2 sites in United States.
Trial summary
This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- MonaLisa Touch and Topical steroid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Apr 2022to 3 Jun 2024
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with biopsy proven lichen sclerosus and significant symptoms based on Skindex-29 scores >21
Who cannot join
- prior vaginal mesh or pelvic radiation
- active genital infection
- Current or past gynecologic malignancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
USA Health Children's and Women's Hospital
Mobile, Alabama, 36604
USA Health Strata Patient Center
Mobile, Alabama, 36604
About this study
Official title: A Randomized, Unblinded Trial of Topical Steroids Plus CO2 Laser Compared to Steroids Alone in the Treatment of Vulvovaginal Lichen Sclerosus
This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.
Read the detailed description
Vulvar lichen sclerosus is a common benign skin condition which causes pain and itching. Topical steroids have been the main treatment. A recent study showed that fractionated CO2 laser treatment is non inferior and actually may improve subjective symptoms compared to topical steroids with no serious safety or adverse events. Because steroids reduce risk of vulvar cancer in patients with lichen sclerosus, the investigators hypothesize that steroids in addition to the fractionated laser will provide greater symptom relief while still allowing patient the benefits of steroid treatment.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- MonaLisa Touch, Topical steroid
- Keywords
- MonaLisa Touch, fractionated laser, SMARTXIDE2
- Medical subject headings
- Vulvar Lichen Sclerosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonaLisa TouchDevice
Also called SMARTXIDE2
3 laser treatments at 6 week intervals for 6 months by a single trained operator
Topical steroidDrug
Also called clobetasol propionate
self-applied topical steroid therapy using clobetasol propionate 0.05%
| Study group | Role | What they receive |
|---|---|---|
| Fractionated CO2 laser plus topical steroids | Experimental | 3 laser treatments at 6 week intervals for 6 months by a single trained operator Receives: Device: MonaLisa Touch; Drug: Topical steroid |
| topical steroids alone | Active comparator | self-applied topical steroid therapy using clobetasol propionate 0.05% Receives: Drug: Topical steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skindex-29 Score
The Skindex-29 is a validated tool to assess impact of a chronic skin condition on a person's quality of life. It has been previously used to describe the effects of a treatment and to compare treatments. Values range from 1 (Never) to 5 (All the time). The higher the score, the worse the outcome.
Measured: Completed by the subject at baseline and 6 months.
Secondary outcomes (7)
Change in Objective Visual Analog Scale
Providers will use this scale to objectively assess vulvar appearance. The tool uses is scored from 0 to 3 (0= absent, 1= mild, 2= moderate, 3= severe) on nine different features of lichen sclerosus (white plaques or hypopigementation, cigarette paper or thin skin, introital narrowing, perianal involvment, loss of labia minora, fusion of labia minora, vulvar fissures, and vulvar erosion). A higher score indicates a higher severity. A higher change in score indicates greater improvement.
Measured: Scored by the provider at baseline and 6 months
Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score)
This 21 item questionnaire assess four aspects impacting quality of life for patients with vulvovaginal skin diseases: symptoms, emotions, life impact and sexual impact. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Measured: Administered at baseline and at 6 months by the provider.
Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only)
A subset of the total score on the VSQ, looking at symptoms only. A higher score corresponds to more bothersome symptoms. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Measured: Administered at baseline and at 6 months by the provider.
Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only)
A subset of the total score on the VSQ, looking at scores for emotions questions only. A higher score corresponds to more emotional impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Measured: Administered at baseline and at 6 months by the provider.
Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only)
A subset of the total score on the VSQ, looking at scores for life impact questions only. A higher score corresponds to more impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Measured: Administered at baseline and at 6 months by the provider.
Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only)
A subset of the total score on the VSQ, looking at scores for sexual impact questions only. A higher score corresponds to more impact. The values are 0 (No) or 1 (Yes). The higher the score, the worse the outcome. A higher change in these scores indicates more improvement.
Measured: Administered at baseline and 6 months by an investigator to the subject
Change in Symptom Subjective Visual Analog Score
This measures the subjects perception of 9 key vulvovaginal symptoms: itching, burning, irritation, pain with intercourse, tearing of vulvar skin, painful urination and painful defecation. Each is scored from 0 -10, with 10 indicating the most symptoms.
Measured: Administered at baseline and 6 months by an investigator to the subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start13 Apr 2022
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Why it stopped: Inability to obtain recruitment levels needed for study to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vulvar Lichen SclerosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Hanes, MD, Principal investigator, Adjunct Associate Professor of Obstetrics and GynecologyStephen Varner, MD, Principal investigator, Associate Professor of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243563
- Sponsor's protocol ID
- 1731682-3
- Status last verified
- Jun 2025
- First submitted
- 7 Feb 2022
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Unblinded Trial of Topical Steroids Plus CO2 Laser Compared to Steroids Alone in the Treatment of Vulvovaginal Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT05243563
- Acronym / sponsor ID
- 1731682-3
- Conditions
- Vulvar Lichen Sclerosus
- Keywords
- MonaLisa Touch, fractionated laser, SMARTXIDE2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to obtain recruitment levels needed for study to continue.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Posted 18 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.
Detailed description
Vulvar lichen sclerosus is a common benign skin condition which causes pain and itching. Topical steroids have been the main treatment. A recent study showed that fractionated CO2 laser treatment is non inferior and actually may improve subjective symptoms compared to topical steroids with no serious safety or adverse events. Because steroids reduce risk of vulvar cancer in patients with lichen sclerosus, the investigators hypothesize that steroids in addition to the fractionated laser will provide greater symptom relief while still allowing patient the benefits of steroid treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractionated CO2 laser plus topical steroids | Experimental | Device: MonaLisa Touch, Drug: Topical steroid3 laser treatments at 6 week intervals for 6 months by a single trained operator |
| topical steroids alone | Active comparator | Drug: Topical steroidself-applied topical steroid therapy using clobetasol propionate 0.05% |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women with biopsy proven lichen sclerosus and significant symptoms based on Skindex-29 scores >21
Key exclusion criteria (3 listed)
- prior vaginal mesh or pelvic radiation
- active genital infection
- Current or past gynecologic malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonaLisa TouchAlso: SMARTXIDE23 laser treatments at 6 week intervals for 6 months by a single trained operator | Device | Fractionated CO2 laser plus topical steroids |
| Topical steroidAlso: clobetasol propionateself-applied topical steroid therapy using clobetasol propionate 0.05% | Drug | Fractionated CO2 laser plus topical steroids, topical steroids alone |
Primary outcome
Change in Skindex-29 Score
Time frame: Completed by the subject at baseline and 6 months.
The Skindex-29 is a validated tool to assess impact of a chronic skin condition on a person's quality of life. It has been previously used to describe the effects of a treatment and to compare treatments. Values range from 1 (Never) to 5 (All the time). The higher the score, the worse the outcome.
7 secondary outcomes
Change in Objective Visual Analog Scale
Time frame: Scored by the provider at baseline and 6 months
Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score)
Time frame: Administered at baseline and at 6 months by the provider.
Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only)
Time frame: Administered at baseline and at 6 months by the provider.
Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only)
Time frame: Administered at baseline and at 6 months by the provider.
Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only)
Time frame: Administered at baseline and at 6 months by the provider.
Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only)
Time frame: Administered at baseline and 6 months by an investigator to the subject
Change in Symptom Subjective Visual Analog Score
Time frame: Administered at baseline and 6 months by an investigator to the subject
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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VALOR: Vaginal Atrophy & Long-term Observation of Recovery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Hanes, MD principal investigator
Adjunct Associate Professor of Obstetrics and Gynecology
Stephen Varner, MD principal investigator
Associate Professor of Obstetrics and Gynecology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MonaLisa Touch and Topical steroid in people with Vulvar Lichen Sclerosus, run by University of South Alabama at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skindex-29 Score (time frame: Completed by the subject at baseline and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.