Lichen SclerosusNCT03665584
MonaLisa Touch Laser for the Treatment of Vulvar Lichen Sclerosus
A study testing FxCO2 Laser in people with Lichen Sclerosus, run by Center for Vulvovaginal Disorders at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lichen Sclerosus
- What is being tested?
- FxCO2 Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2018to 14 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are 18 years or older.
- Have a diagnosis of active lichen sclerosus (Dr. Goldstein will remove a pea size amount of skin (a biopsy) and will do a physical assessment of the vulva area at the beginning of the study to confirm this diagnosis).
- Are willing and able to comply with the study requirements.
- Have a negative pregnancy test prior to enrolling in this study and will use at least one form of birth control during the course of the study if you are sexually active and are of child bearing potential.
- Have at least a 3 out of 10 on a questionnaire that measures the amount of itching you are having.
Who cannot join
- Are immunocompromised (have a lowered immune system) (for example, you have been diagnosed with or have a history of lymphoma, AIDS, or Wiskott-Aldrich Syndrome), or have an uncontrolled malignant disease.
- Have a generalized infection (bacterial, viral or fungal), or obvious localized infections in the vulva area.
- Have swollen lymph nodes (lymphadenopathy).
- Have any active sexually transmitted diseases on the vulva (herpes, molluscum, condyloma).
- Have been diagnosed with other vulvar dermatologic conditions including lichen planus, psoriasis, lichen simplex chronicus, candidiasis, intraepithelial neoplasia, or carcinoma.
- Are pregnant or breastfeeding.
Show all 13Show fewer
- If you become pregnant while on the study, you must withdraw from the study.
- Have received an investigational drug within four weeks prior to the study or who plan to use other investigational drugs during the course of this study.
- Have severe medical condition(s) that in the view of the study doctor prohibits participation in the study.
- Have a history of substance abuse or any factor, which limits your ability to cooperate with the study procedures.
- Are uncooperative or are not willing to attend regular visits.
- Have received systemic immunosuppressants (steroids), other systemic therapies or any other systemic therapies known or suspected to have an effect on vulvar lichen sclerosus within 4 weeks prior to participation in the study.
- Have been treated with topical therapy (for example, topical corticosteroids, pimecrolimus, tacrolimus) or any other topical therapies known or suspected to have an effect on vulvar lichen sclerosus or its symptoms within 4 weeks prior to participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Centers for Vulvovaginal Disorders
Washington D.C., District of Columbia, 20037
About this study
Official title: A Double Blinded Sham Controlled Trial of Fractional CO2 Laser Treatment Using the DEKA SmartXide Touch Laser System (MonaLisa Touch) 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 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.
Read more
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).
Read the detailed description
Lichen sclerosus (LS) is a chronic cutaneous disorder affecting approximately one in seventy women. Presenting symptoms may include intense pruritus, pain, burning, and severe dyspareunia. This disorder may affect any area of the skin, but has a notable predilection for the anogenital skin. Extra-genital involvement is infrequent, affecting only 11% of women with LS. Affected females outnumber affect males by 10:1. There is bimodal peak incidence in premenarchal girls and menopausal women with an average age of onset of 51 years of age.
The typical lesions of LS are white plaques and papules, often with areas of ecchymosis, excoriation, and ulceration. Often, there is destruction of the vulva architecture with scarring of the clitoral prepuce, resorption of the labia minora, and narrowing of the introitus. Four to six percent of women with LS will develop vulvar carcinoma. The histopathologic changes of LS are distinctive and make biopsy a very useful diagnostic tool. Characteristic pathologic finding include hyperkeratosis of the epidermis, epidermal atrophy with loss of rete ridges, homogenization of the collagen in the upper dermis, and a lichenoid (band-like) inflammatory infiltrate in the dermis. While there is no known cure for LS, the current gold standard treatment is ultra-potent corticosteroids. When properly administered, topical ultra-potent corticosteroids help to resolve the symptoms of pruritus and burning and can prevent further vulvar scarring. In addition, proper treatment reverses the underlying histopathologic changes of LS, and preliminary data shows that the risk of malignant transformation also declines.
Although treatment with topical corticosteroids is effective, topical corticosteroids may have serious local and systemic side effects, including dermal thinning, skin atrophy, superimposed infections, rebound dermatitis, and adrenal insufficiency. Due to these side effects, long- term use of corticosteroids for the treatment of vulvar lichen sclerosus may be inadvisable. Therefore, a safe and effective alternative intervention is needed for this disorder.
Recently, microablative fractional CO 2 laser (SmartXide 2 V 2 LR CO 2 laser system, for MonaLisa Touch, DEKA, Florence, Italy) has been proposed for the management of LS. This type of laser has a wavelength of 10,600 nm that allows a superficial microablative effect in soft tissues and a pulsed beam that protects the tissues from possible overheating damage. The laser beam is delivered to the tissue in a fractional manner, creating small spots (called DOTs) alternating parts of tissue treated and not treated. The size of each DOT is set by the manufacturer at 150 - 200 μm. Moreover, it has a DEKA pulse (D-pulse) mode that consists of two parts: (a) constant, high energy peak power, for rapid superficial evaporation of the atrophic epithelium with low water content and (b) lower peak power with longer emission times that allows the energy heat to penetrate deeper in the epithelium. This D-pulse mode combined with DOTs remodels the connective tissue via the production of heat shock protein 47 and produces new collagen/fibroblasts and ground matrix.
Recently, two small studies demonstrated that fractional CO 2 laser (FxCO 2 ) therapy appears to be a promising treatment modality to treat lichen sclerosus. These studies demonstrated that FxCO 2 treatment may stimulate protein synthesis, accelerate tissue reconstruction, and decrease lichenification. Furthermore, after elimination of local inflammation, the stimulus of nerve endings was reduced, so the clinical manifestations of LS, such as intense vulvar pruritus and burning were improved.
- Conditions
- Lichen Sclerosus
- Being tested
- FxCO2 Laser, Sham Laser
- Keywords
- Lichen Sclerosus, MonaLisa Touch
- Medical subject headings
- Lichen Sclerosus et Atrophicus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FxCO2 LaserDevice
The FxCO2 laser allows a microablative effect in soft tissue.
Sham LaserDevice
The Sham laser will be used on the participants who receive the sham treatment.
| Study group | Role | What they receive |
|---|---|---|
| FxCO2 Laser | Active comparator | FxCO2 laser treatment will be performed by scanning across the entire affected anogenital region. The FxCO2 treatment will be performed at baseline and then repeated at 4 week intervals for a total of 5 treatments. The laser parameters change with each treatment: power (18, 20, 22, 24, 26W), dwell time (800, 900, 1000, 1000, 1000us) and spacing (1200, 1100, 1000, 1000, 1000um) in respective order. Receives: Device: FxCO2 Laser |
| Sham Laser | Sham comparator | Sham laser treatment will be performed by scanning across the entire affected anogenital region. The sham treatment will be performed using 4W (power), 400us (dwell time), and 1500um (spacing). The laser has no effect on the vulvar tissue using these parameters. Receives: Device: Sham Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Infiltration
A blinded dermatopathologist will evaluate the inflammatory infiltration on biopsy specimens obtained during screening process and after 24-week treatment period.
Measured: 26 weeks
Secondary outcomes (1)
Changes from Baseline in Clinical Scoring System for Vulvar Lichen Sclerosus
A validated scoring system will assess both the investigator's impression of the severity of the disease and the patient's impression of the severity of her disease at weeks 0, 14, and 26.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start28 Aug 2018
- Primary completion15 Apr 2020
- Study completion14 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Vulvovaginal Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- Gynecologic Cancer Research Foundation, El. En. SpA
- Responsible party
- Sponsor
- Investigators
- Andrew Goldstein, MD, Principal investigator, The Centers for Vulvovaginal Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665584
- Sponsor's protocol ID
- Pro00024516
- Status last verified
- Nov 2020
- First submitted
- 6 Aug 2018
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mitchell L, Goldstein AT, Heller D, Mautz T, Thorne C, Joyce Kong SY, Sophocles ME, Tolson H, Krapf JM. Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):979-987. doi: 10.1097/AOG.0000000000004409.
PubMed 33957648
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blinded Sham Controlled Trial of Fractional CO2 Laser Treatment Using the DEKA SmartXide Touch Laser System (MonaLisa Touch) for the Treatment of Vulvar Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT03665584
- Acronym / sponsor ID
- Pro00024516
- Conditions
- Lichen Sclerosus
- Keywords
- Lichen Sclerosus, MonaLisa Touch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Center for Vulvovaginal DisordersUniversity, hospital or other
- Collaborators
- Gynecologic Cancer Research Foundation, El. En. SpA
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Lichen sclerosus (LS) is a chronic cutaneous disorder affecting approximately one in seventy women. Presenting symptoms may include intense pruritus, pain, burning, and severe dyspareunia. This disorder may affect any area of the skin, but has a notable predilection for the anogenital skin. Extra-genital involvement is infrequent, affecting only 11% of women with LS. Affected females outnumber affect males by 10:1. There is bimodal peak incidence in premenarchal girls and menopausal women with an average age of onset of 51 years of age.
The typical lesions of LS are white plaques and papules, often with areas of ecchymosis, excoriation, and ulceration. Often, there is destruction of the vulva architecture with scarring of the clitoral prepuce, resorption of the labia minora, and narrowing of the introitus. Four to six percent of women with LS will develop vulvar carcinoma. The histopathologic changes of LS are distinctive and make biopsy a very useful diagnostic tool. Characteristic pathologic finding include hyperkeratosis of the epidermis, epidermal atrophy with loss of rete ridges, homogenization of the collagen in the upper dermis, and a lichenoid (band-like) inflammatory infiltrate in the dermis. While there is no known cure for LS, the current gold standard treatment is ultra-potent corticosteroids. When properly administered, topical ultra-potent corticosteroids help to resolve the symptoms of pruritus and burning and can prevent further vulvar scarring. In addition, proper treatment reverses the underlying histopathologic changes of LS, and preliminary data shows that the risk of malignant transformation also declines.
Although treatment with topical corticosteroids is effective, topical corticosteroids may have serious local and systemic side effects, including dermal thinning, skin atrophy, superimposed infections, rebound dermatitis, and adrenal insufficiency. Due to these side effects, long- term use of corticosteroids for the treatment of vulvar lichen sclerosus may be inadvisable. Therefore, a safe and effective alternative intervention is needed for this disorder.
Recently, microablative fractional CO 2 laser (SmartXide 2 V 2 LR CO 2 laser system, for MonaLisa Touch, DEKA, Florence, Italy) has been proposed for the management of LS. This type of laser has a wavelength of 10,600 nm that allows a superficial microablative effect in soft tissues and a pulsed beam that protects the tissues from possible overheating damage. The laser beam is delivered to the tissue in a fractional manner, creating small spots (called DOTs) alternating parts of tissue treated and not treated. The size of each DOT is set by the manufacturer at 150 - 200 μm. Moreover, it has a DEKA pulse (D-pulse) mode that consists of two parts: (a) constant, high energy peak power, for rapid superficial evaporation of the atrophic epithelium with low water content and (b) lower peak power with longer emission times that allows the energy heat to penetrate deeper in the epithelium. This D-pulse mode combined with DOTs remodels the connective tissue via the production of heat shock protein 47 and produces new collagen/fibroblasts and ground matrix.
Recently, two small studies demonstrated that fractional CO 2 laser (FxCO 2 ) therapy appears to be a promising treatment modality to treat lichen sclerosus. These studies demonstrated that FxCO 2 treatment may stimulate protein synthesis, accelerate tissue reconstruction, and decrease lichenification. Furthermore, after elimination of local inflammation, the stimulus of nerve endings was reduced, so the clinical manifestations of LS, such as intense vulvar pruritus and burning were improved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FxCO2 Laser | Active comparator | Device: FxCO2 LaserFxCO2 laser treatment will be performed by scanning across the entire affected anogenital region. The FxCO2 treatment will be performed at baseline and then repeated at 4 week intervals for a total of 5 treatments. The laser parameters change with each treatment: power (18, 20, 22, 24, 26W), dwell time (800, 900, 1000, 1000, 1000us) and spacing (1200, 1100, 1000, 1000, 1000um) in respective order. |
| Sham Laser | Sham comparator | Device: Sham LaserSham laser treatment will be performed by scanning across the entire affected anogenital region. The sham treatment will be performed using 4W (power), 400us (dwell time), and 1500um (spacing). The laser has no effect on the vulvar tissue using these parameters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are 18 years or older.
- Have a diagnosis of active lichen sclerosus (Dr. Goldstein will remove a pea size amount of skin (a biopsy) and will do a physical assessment of the vulva area at the beginning of the study to confirm this diagnosis).
- Are willing and able to comply with the study requirements.
- Have a negative pregnancy test prior to enrolling in this study and will use at least one form of birth control during the course of the study if you are sexually active and are of child bearing potential.
- Have at least a 3 out of 10 on a questionnaire that measures the amount of itching you are having.
Key exclusion criteria (13 listed)
- Are immunocompromised (have a lowered immune system) (for example, you have been diagnosed with or have a history of lymphoma, AIDS, or Wiskott-Aldrich Syndrome), or have an uncontrolled malignant disease.
- Have a generalized infection (bacterial, viral or fungal), or obvious localized infections in the vulva area.
- Have swollen lymph nodes (lymphadenopathy).
- Have any active sexually transmitted diseases on the vulva (herpes, molluscum, condyloma).
- Have been diagnosed with other vulvar dermatologic conditions including lichen planus, psoriasis, lichen simplex chronicus, candidiasis, intraepithelial neoplasia, or carcinoma.
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 |
|---|---|---|
| FxCO2 LaserThe FxCO2 laser allows a microablative effect in soft tissue. | Device | FxCO2 Laser |
| Sham LaserThe Sham laser will be used on the participants who receive the sham treatment. | Device | Sham Laser |
Primary outcome
Inflammatory Infiltration
Time frame: 26 weeks
A blinded dermatopathologist will evaluate the inflammatory infiltration on biopsy specimens obtained during screening process and after 24-week treatment period.
1 secondary outcome
Changes from Baseline in Clinical Scoring System for Vulvar Lichen Sclerosus
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Derived from this study: PubMed 33957648Mitchell L, Goldstein AT, Heller D, Mautz T, Thorne C, Joyce Kong SY, Sophocles ME, Tolson H, Krapf JM. Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):979-987. doi: 10.1097/AOG.0000000000004409.
- Individual participant dataSharing planned: No
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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.
Andrew Goldstein, MD principal investigator
The Centers for Vulvovaginal Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FxCO2 Laser in people with Lichen Sclerosus, run by Center for Vulvovaginal Disorders at 1 site 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 5 inclusion and 13 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 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inflammatory Infiltration (time frame: 26 weeks). 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 NCT03665584, which also lists 1 linked publication.
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 12 Nov 2020.