Vulvar Lichen SclerosusNCT04148651

The CO2RE® System for Vulvar Lichen Sclerosus

A study testing The CO2RE® System in people with Vulvar Lichen Sclerosus, run by Candela Corporation at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years, women only
Conditions the study is for: Vulvar Lichen Sclerosus
What is being tested?: The CO2RE® System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 4 sitesUnited States
Study dates: 11 Jul 2018to 17 Dec 2020
Phase: Interventional
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 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to read, understand and sign informed consent for study participation;
Female subjects with age 18-80 years;
Biopsy demonstrates biopsy-proven lichen sclerosus and/or there are characteristic changes for vulvar lichen sclerosus on physical examination;
Treatment of LS has been recalcitrant to mid to high-potent topical corticosteroid treatment or subject refuses topical corticosteroid treatment. Recalcitrance to therapy is defined as no response to topical corticosteroids of an adequate potency (i.e. clobetasol propionate 0.05% ointment or other steroids) and a sufficient duration (12 weeks of use) or lack of symptomatic control of the disease with a maintenance therapy;
Topical corticosteroid treatment, if any, will be continued during the study period;
Exogenous hormone treatment, if any, will be continued during the study period (type and dose must stay consistent throughout the study);
One or more of the following symptoms: itch; pain unrelated to intercourse; pain, skin tearing or bleeding with intercourse; changes/decrease in sexual function;
No breaks, tears or lesions, malodorous discharge or strawberry cervix present on gynecological exam.

Who cannot join

Presence of clinically atypical appearing nevi in the area to be treated;
Unexplained vaginal bleeding;
Active infection, specifically: urinary tract infection, vulvar or vaginal infection (candidiasis, genital herpes/herpes simplex virus, bacterial vaginosis, trichomonas);
History of vulvar or any gynecological malignancy, as well as history of pelvic radiation therapy or stem cell transplant;
Pelvic organ prolapse > stage 2;
Pregnancy or planning pregnancy during the study;
Systemic treatment with immuno-modulatory drugs.
Use of vaginal dilators during study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

HERmd (formerly Somi Javaid M.D. & Associates)
Cincinnati, Ohio, 45249
Total Dermatology Care Center
Jacksonville, Florida, 32204
Center for Modern Aesthetic Medicine
Jacksonville, Florida, 32207
Lumina Med Spa
South Burlington, Vermont, 05403

Other trials in United States

About this study

Official title: Clinical Study of the CO2RE® Laser Device for Treatment of Vulvar Lichen Sclerosus

Read the detailed description

This study is a prospective, non-randomized, single-group assignment, interventional clinical trial. Female subjects with vulvar lichen sclerosus (VLS) supported by histologic findings on biopsy and/or clinical signs on physical examination and recalcitrant to mid- to high-potency steroid therapy, will undergo up to 5 monthly treatments to the vulva with a fractional CO2 laser.

Investigators will assess clinical signs and architectural changes associated with VLS. Baseline measurements will be compared to follow-up at 6 weeks, 3 months, 6 months and 12 months after the final treatment.

Subjects will self report sexual function using a validated FSFI Questionnaire at baseline and at the 3- and 6-month follow-ups.

Conditions: Vulvar Lichen Sclerosus
Being tested: The CO2RE® System
Keywords: vulvar dystrophy, vulvar atrophy, persistent itching, leukoplakia, hyperkeratosis, sexual function
Medical subject headings: Vulvar Lichen Sclerosus, Leukoplakia, Keratoderma, Palmoplantar, Epidermolytic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The CO2RE® SystemDevice
The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of leukoplakia (vulvar dystrophies).

Study groups in NCT04148651
Study group	Role	What they receive
CO2RE® Treatment	Experimental	All eligible subjects will undergo up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser. Receives: Device: The CO2RE® System

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators
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 each endpoint to evaluate overall treatment outcome, as follows:
Average severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of clinical signs present at baseline for each subject / Number of grades
A lower average score means better outcome.
Measured: At Baseline, 3, 6 and 12 months after the final treatment
Average Scores for VLS Architectural Changes Present At Baseline and at 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators
Each architectural change of VLS (labial fusion, clitoral hood fusion, narrowing of the introitus, anterior changes, perianal involvement, formation of posterior commissure bands) 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 architectural changes present at baseline (baseline score >0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows:
Average severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of architectural changes present at baseline for each subject / Number of grades
A lower average score means better outcome.
Measured: Baseline, 3 , 6 and 12 months after the final treatment

Secondary outcomes (3)

Change From Baseline in Sexual Function on the Female Sexual Function Index (FSFI) at 3 Months and 6 Months After the Final Treatment
Female Sexual Function Index (FSFI) is a validated, self-reported 19-item questionnaire that assesses domains of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain. The aggregated FSFI score is a sum of weighted answers for each of the 19 items in the questionnaire, with a maximum total score possible of 36.0 (high level of sexual functional) and minimum score of 2.0 (low level of sexual functional). Change = (Follow-up score - Baseline score). Mean change was calculated for all scores at the 3- and 6-month follow-ups.
Measured: Baseline and 3 months and 6 months after the final treatment
Subject Satisfaction At the 12-Month Follow-up
Evaluate Subject satisfaction at the 12 months post-last treatment visit, using a satisfaction scale [(-2) Very dissatisfied, (-1) Dissatisfied, (0) Uncertain, (1) Satisfied, (2) Very satisfied]. The analysis quantify the percentage of Subject satisfaction (score 1 or 2) at the 12-month follow-up.
Measured: 12 months after the final treatment
Treatment Associated Pain Score
Subjects underwent 3-5 monthly treatments and reported discomfort associated with treatment on a 10-cm visual analogue scale (VAS) of 0 = no pain to 10 = worst possible pain, immediately after each treatment. The outcome presented here is the mean grade of discomfort/pain associated with all treatments. Lower value presents lower treatment-associated discomfort. Since patients received 3-5 monthly treatments these values were collected at each treatment over a period of 2 to 4 months for each patient.
Measured: Immediately after the 1st, 2nd, 3rd, 4th and 5th monthly treatments post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 201817 Dec 2020

First posted1 Nov 2019
Study start11 Jul 2018
Primary completion30 Jul 2020
Study completion17 Dec 2020

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.
Publications (5)Papers the sponsor has linked to this study.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single Group Assignment
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04148651
Sponsor's protocol ID: DHF25211
Status last verified: Feb 2022
First submitted: 29 Oct 2019
Last updated: 22 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Sheinis M, Selk A. Development of the Adult Vulvar Lichen Sclerosus Severity Scale-A Delphi Consensus Exercise for Item Generation. J Low Genit Tract Dis. 2018 Jan;22(1):66-73. doi: 10.1097/LGT.0000000000000361.
PubMed 29095746
Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
PubMed 10782451
Thorstensen KA, Birenbaum DL. Recognition and management of vulvar dermatologic conditions: lichen sclerosus, lichen planus, and lichen simplex chronicus. J Midwifery Womens Health. 2012 May-Jun;57(3):260-75. doi: 10.1111/j.1542-2011.2012.00175.x.
PubMed 22594865
Salvatore S, Leone Roberti Maggiore U, Athanasiou S, Origoni M, Candiani M, Calligaro A, Zerbinati N. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015 Aug;22(8):845-9. doi: 10.1097/GME.0000000000000401.
PubMed 25608269
Stewart K, Javaid S, Schallen KP, Bartlett S, Carlson NA. Fractional CO2 laser treatment as adjunctive therapy to topical steroids for managing vulvar lichen sclerosus. Lasers Surg Med. 2022 Jan;54(1):138-151. doi: 10.1002/lsm.23476. Epub 2021 Sep 20.
PubMed 34541702

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus
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All Vulvar Lichen Sclerosus trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of the CO2RE® Laser Device for Treatment of Vulvar Lichen Sclerosus
ClinicalTrials.gov ID: NCT04148651
Acronym / sponsor ID: DHF25211
Conditions: Vulvar Lichen Sclerosus
Keywords: vulvar dystrophy, vulvar atrophy, persistent itching, leukoplakia, hyperkeratosis, sexual function
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Candela CorporationIndustry (pharma, biotech, devices)
Study start: 11 Jul 2018 (actual)
Primary completion: 30 Jul 2020 (actual)
Study completion: 17 Dec 2020 (actual)
First posted: 1 Nov 2019 (actual)
Results: Posted 22 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects will self report sexual function using a validated FSFI Questionnaire at baseline and at the 3- and 6-month follow-ups.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single Group Assignment

Arm	Type	Receives
CO2RE® Treatment	Experimental	Device: The CO2RE® SystemAll eligible subjects will undergo up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser.

Who may qualify

Ages: 18 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Able to read, understand and sign informed consent for study participation;
Female subjects with age 18-80 years;
Biopsy demonstrates biopsy-proven lichen sclerosus and/or there are characteristic changes for vulvar lichen sclerosus on physical examination;
Treatment of LS has been recalcitrant to mid to high-potent topical corticosteroid treatment or subject refuses topical corticosteroid treatment. Recalcitrance to therapy is defined as no response to topical corticosteroids of an adequate potency (i.e. clobetasol propionate 0.05% ointment or other steroids) and a sufficient duration (12 weeks of use) or lack of symptomatic control of the disease with a maintenance therapy;
Topical corticosteroid treatment, if any, will be continued during the study period;

Key exclusion criteria (8 listed)

Presence of clinically atypical appearing nevi in the area to be treated;
Unexplained vaginal bleeding;
Active infection, specifically: urinary tract infection, vulvar or vaginal infection (candidiasis, genital herpes/herpes simplex virus, bacterial vaginosis, trichomonas);
History of vulvar or any gynecological malignancy, as well as history of pelvic radiation therapy or stem cell transplant;
Pelvic organ prolapse > stage 2;

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
The CO2RE® SystemThe CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of leukoplakia (vulvar dystrophies).	Device	CO2RE® Treatment

Primary outcome

Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators
Time frame: At Baseline, 3, 6 and 12 months after the final treatment
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 each endpoint to evaluate overall treatment outcome, as follows: Average severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of clinical signs present at baseline for each subject / Number of grades A lower average score means better outcome.
Average Scores for VLS Architectural Changes Present At Baseline and at 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators
Time frame: Baseline, 3 , 6 and 12 months after the final treatment
Each architectural change of VLS (labial fusion, clitoral hood fusion, narrowing of the introitus, anterior changes, perianal involvement, formation of posterior commissure bands) 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 architectural changes present at baseline (baseline score >0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows: Average severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of architectural changes present at baseline for each subject / Number of grades A lower average score means better outcome.

3 secondary outcomes

Change From Baseline in Sexual Function on the Female Sexual Function Index (FSFI) at 3 Months and 6 Months After the Final Treatment
Time frame: Baseline and 3 months and 6 months after the final treatment
Subject Satisfaction At the 12-Month Follow-up
Time frame: 12 months after the final treatment
Treatment Associated Pain Score
Time frame: Immediately after the 1st, 2nd, 3rd, 4th and 5th monthly treatments post baseline

Results and safety

Results posted to the registry on 22 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CO2RE® Treatment	12	10

Primary outcome: Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators

Time frame: At Baseline, 3, 6 and 12 months after the final treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	CO2RE® Treatment n = 12
Average score of clinical signs at Baseline	1.85 (0.73)
Average score of clinical signs at 3-months follow-up visit	0.65 (0.74)
Average score of clinical signs at 6-months follow-up visit	0.65 (0.76)
Average score of clinical signs at 12-months follow-up visits	0.73 (0.83)

Population analysed: At Baseline, 12 subjects had 96 clinical signs present (score \>0). One subject missed the 12-month follow-up, one subject missed the 3- and 12-month follow-ups and one subject missed the 6-month follow-up. Hence, at 3- and 6-month follow-up visits 11 subjects were assessed (with 89 clinical signs averaged for each visit) and at the 12-month follow-up visit 10 subjects were assessed (with 79 clinical signs averaged).

Primary outcome: Average Scores for VLS Architectural Changes Present At Baseline and at 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators

Time frame: Baseline, 3 , 6 and 12 months after the final treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	CO2RE® Treatment n = 12
Average score of architectural changes at Baseline	2.18 (0.72)
Average score of architectural changes at 3-month follow-up	1.10 (0.90)
Average score of architectural changes at 6-month follow-up	1.04 (0.87)
Average score of architectural changes at 12-month follow-up	1.08 (0.91)

Population analysed: At Baseline, 12 patients had 55 architectural changes present (score \>0). One subject missed the 12-month follow-up, one subject missed the 3- and 12-month follow-ups and one subject missed the 6-month follow-up. Hence, at the 3- and 6-month follow-ups, 11 subjects were assessed (with 51 architectural changes averaged for each visit) and at the 12-month follow-up 10 subjects were assessed (with 49 architectural changes averaged).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The period of time over which adverse event data were collected is from treatment visit until 12-month follow-up (16 month post last treatment).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Treated With CO2RE® Treatment	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): Small sample size of subjects enrolled and analyzed due to delayed start at one clinical site and COVID-19 pandemic.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29095746Sheinis M, Selk A. Development of the Adult Vulvar Lichen Sclerosus Severity Scale-A Delphi Consensus Exercise for Item Generation. J Low Genit Tract Dis. 2018 Jan;22(1):66-73. doi: 10.1097/LGT.0000000000000361.
Background: PubMed 10782451Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
Background: PubMed 22594865Thorstensen KA, Birenbaum DL. Recognition and management of vulvar dermatologic conditions: lichen sclerosus, lichen planus, and lichen simplex chronicus. J Midwifery Womens Health. 2012 May-Jun;57(3):260-75. doi: 10.1111/j.1542-2011.2012.00175.x.
Background: PubMed 25608269Salvatore S, Leone Roberti Maggiore U, Athanasiou S, Origoni M, Candiani M, Calligaro A, Zerbinati N. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015 Aug;22(8):845-9. doi: 10.1097/GME.0000000000000401.
Results publication: PubMed 34541702Stewart K, Javaid S, Schallen KP, Bartlett S, Carlson NA. Fractional CO2 laser treatment as adjunctive therapy to topical steroids for managing vulvar lichen sclerosus. Lasers Surg Med. 2022 Jan;54(1):138-151. doi: 10.1002/lsm.23476. Epub 2021 Sep 20.
Individual participant dataSharing planned: No

Related trials for Vulvar Lichen Sclerosus

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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.

Konika P Schallen, MD study director

Candela Corporation

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The CO2RE® System in people with Vulvar Lichen Sclerosus, run by Candela Corporation at 4 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2021). 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?

Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators (time frame: At Baseline, 3, 6 and 12 months after the final treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04148651, which also lists 5 linked publications.

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 22 Mar 2022.