Chronic Skin DiseaseNCT03926299
Clinical Trial to Demonstrate That the Dual Laser Therapy is Effective for the Treatment of Vulvar Lichen Sclerosus
A study testing FotonaSmooth SP® Spectro laser device and Clobetasol propionate 0.05% ointment in people with Chronic Skin Disease and Vulvar Lichen Sclerosus, run by Prof. Dr. Volker Viereck at 1 site in Switzerland.
Trial summary
The aim of this study is to test a new, minimally invasive dual laser technique to treat vulvar lichen sclerosus. Efficacy and safety of the thermal non-ablative Nd:YAG laser and the ablative Er:YAG laser is determined and compared to the current standard treatment with high dose steroids. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Skin Disease, Vulvar Lichen Sclerosus
- What is being tested?
- FotonaSmooth SP® Spectro laser device and Clobetasol propionate 0.05% ointment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jul 2019to 30 Jul 2024
- 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
- Diagnosis of vulvar lichen sclerosus
- Clinical LS score ≥ 4
Who cannot join
- Concomitant steroid, calcineurin inhibitor or any other topical or systemic treatment for LS
- < 3 months since start of vaginal estrogen treatment
- Malignant disease as the cause of the vulval symptoms
- BMI > 35 kg/m²
- Acute infection (fungal, bacterial, viral) of the vulva, vagina or bladder
- Presence of contraindications for the laser treatment or topical steroid treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Active-controlled Investigator Initiated Clinical Trial to Demonstrate That the Nd:YAG/Er:YAG Dual Laser Therapy is Effective to Treat Vulvar Lichen Sclerosus and Similar to Standard Treatment With Steroid Cream
The aim of this study is to test a new, minimally invasive dual laser technique to treat vulvar lichen sclerosus. Efficacy and safety of the thermal non-ablative Nd:YAG laser and the ablative Er:YAG laser is determined and compared to the current standard treatment with high dose steroids. The hypothesis is that laser therapy is effective and similar to standard steroid therapy.
Read the detailed description
Lichen sclerosus (LS) is a chronic inflammatory skin disease that usually involves the anogenital area where it causes itching and burning pain, pain during sexual intercourse, and anal or genital bleeding due to fissuring of the damaged tissue. In this study a treatment with dual laser application combining thermal non-ablative Nd:YAG with ablative Er:YAG laser is used to reduce the symptoms of LS. Results will be compared to the standard therapy with topical steroid cream.
- Conditions
- Chronic Skin Disease, Vulvar Lichen Sclerosus
- Being tested
- FotonaSmooth SP® Spectro laser device, Clobetasol propionate 0.05% ointment
- 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.
FotonaSmooth SP® Spectro laser deviceDevice
Also called Laser therapy
dual laser treatment with thermal Nd:YAG and ablative Er:YAG (Fotona medical device), 4 laser sessions 4-8 weeks apart.
Clobetasol propionate 0.05% ointmentDrug
Also called Local steroid therapy
6 months standard treatment with topical steroid cream (high dose for the first two months, medium dose for the next two months, low dose for the last two months)
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | dual Fotona laser treatment (Nd:YAG and Er:YAG) Receives: Device: FotonaSmooth SP® Spectro laser device |
| Topical steroid | Active comparator | clobetasol propionate 0.05% cream Receives: Drug: Clobetasol propionate 0.05% ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Lichen sclerosus score (LS score)
Reduction (i.e. improvement) of physician administered clinical LS score (Sum score of 6 items on a scale from 0-2 (0=no, 1=weak, 2=pronounced): erosions, hyperkeratosis, fissures, agglutination, stenosis, atrophy). Possible sum score ranges from 0 (normal) to 12 (maximum symptoms present).
Measured: 6 months
Secondary outcomes (2)
Vulvovaginal symptom questionnaire (VSQ)
21 binary questions (0=no, 1=yes) about symptoms, emotional impact, impact on quality of life, impact on sexual activity. Total possible sum score is 21.
Measured: At each visit through study completion, an average of 1 year
Symptom strength score
Visual analog scale (0-10) of LS symptoms itching, burning, vulvar pain, dyspareunia. Total sum score ranges from 0 (no symptoms) to 40 (maximal symptoms).
Measured: At each visit through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start15 Jul 2019
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Skin DiseaseStudies 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
- Model description
- randomized, active-controlled
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Volker Viereck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Volker Viereck, Cantonal Hospital, Frauenfeld
- Investigators
- Volker Viereck, Prof., Principal investigator, Department of Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926299
- Sponsor's protocol ID
- Lichen sclerosus laser study
- Status last verified
- Mar 2026
- First submitted
- 18 Apr 2019
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gamper M, Zivanovic I, Bischofberger H, Viereck V. One-year outcome after laser treatment of vulvar lichen sclerosus: a prospective observational trial. Arch Gynecol Obstet. 2026 Jul 1. doi: 10.1007/s00404-026-08510-3. Online ahead of print.
PubMed 42384057Zivanovic I, Gamper M, Fesslmeier D, Bischofberger H, Viereck V. A randomized controlled trial to evaluate a novel dual laser therapy for vulvar lichen sclerosus: exploratory study assessing the impact of menopausal status. Menopause. 2025 Mar 1;32(3):228-233. doi: 10.1097/GME.0000000000002478. Epub 2025 Feb 21.
PubMed 39998969Viereck V, Gamper M, Regauer S, Walser C, Zivanovic I. Nd:YAG/Er:YAG dual laser vs. topical steroid to treat vulvar lichen sclerosus: study protocol of a randomized controlled trial. Arch Gynecol Obstet. 2023 Aug;308(2):643-649. doi: 10.1007/s00404-023-07055-z. Epub 2023 May 5.
PubMed 37145134
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Active-controlled Investigator Initiated Clinical Trial to Demonstrate That the Nd:YAG/Er:YAG Dual Laser Therapy is Effective to Treat Vulvar Lichen Sclerosus and Similar to Standard Treatment With Steroid Cream
- ClinicalTrials.gov ID
- NCT03926299
- Acronym / sponsor ID
- Lichen sclerosus laser study
- Conditions
- Chronic Skin Disease, Vulvar Lichen Sclerosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Prof. Dr. Volker ViereckUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 24 Apr 2019 (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.
The aim of this study is to test a new, minimally invasive dual laser technique to treat vulvar lichen sclerosus. Efficacy and safety of the thermal non-ablative Nd:YAG laser and the ablative Er:YAG laser is determined and compared to the current standard treatment with high dose steroids. The hypothesis is that laser therapy is effective and similar to standard steroid therapy.
Detailed description
Lichen sclerosus (LS) is a chronic inflammatory skin disease that usually involves the anogenital area where it causes itching and burning pain, pain during sexual intercourse, and anal or genital bleeding due to fissuring of the damaged tissue. In this study a treatment with dual laser application combining thermal non-ablative Nd:YAG with ablative Er:YAG laser is used to reduce the symptoms of LS. Results will be compared to the standard therapy with topical steroid cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, active-controlled
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Device: FotonaSmooth SP® Spectro laser devicedual Fotona laser treatment (Nd:YAG and Er:YAG) |
| Topical steroid | Active comparator | Drug: Clobetasol propionate 0.05% ointmentclobetasol propionate 0.05% cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of vulvar lichen sclerosus
- Clinical LS score ≥ 4
Key exclusion criteria (6 listed)
- Concomitant steroid, calcineurin inhibitor or any other topical or systemic treatment for LS
- < 3 months since start of vaginal estrogen treatment
- Malignant disease as the cause of the vulval symptoms
- BMI > 35 kg/m²
- Acute infection (fungal, bacterial, viral) of the vulva, vagina or bladder
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 |
|---|---|---|
| FotonaSmooth SP® Spectro laser deviceAlso: Laser therapydual laser treatment with thermal Nd:YAG and ablative Er:YAG (Fotona medical device), 4 laser sessions 4-8 weeks apart. | Device | Laser |
| Clobetasol propionate 0.05% ointmentAlso: Local steroid therapy6 months standard treatment with topical steroid cream (high dose for the first two months, medium dose for the next two months, low dose for the last two months) | Drug | Topical steroid |
Primary outcome
Clinical Lichen sclerosus score (LS score)
Time frame: 6 months
Reduction (i.e. improvement) of physician administered clinical LS score (Sum score of 6 items on a scale from 0-2 (0=no, 1=weak, 2=pronounced): erosions, hyperkeratosis, fissures, agglutination, stenosis, atrophy). Possible sum score ranges from 0 (normal) to 12 (maximum symptoms present).
2 secondary outcomes
Vulvovaginal symptom questionnaire (VSQ)
Time frame: At each visit through study completion, an average of 1 year
Symptom strength score
Time frame: At each visit through study completion, an average of 1 year
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 23 Mar 2026.
- Derived from this study: PubMed 42384057Gamper M, Zivanovic I, Bischofberger H, Viereck V. One-year outcome after laser treatment of vulvar lichen sclerosus: a prospective observational trial. Arch Gynecol Obstet. 2026 Jul 1. doi: 10.1007/s00404-026-08510-3. Online ahead of print.
- Derived from this study: PubMed 39998969Zivanovic I, Gamper M, Fesslmeier D, Bischofberger H, Viereck V. A randomized controlled trial to evaluate a novel dual laser therapy for vulvar lichen sclerosus: exploratory study assessing the impact of menopausal status. Menopause. 2025 Mar 1;32(3):228-233. doi: 10.1097/GME.0000000000002478. Epub 2025 Feb 21.
- Derived from this study: PubMed 37145134Viereck V, Gamper M, Regauer S, Walser C, Zivanovic I. Nd:YAG/Er:YAG dual laser vs. topical steroid to treat vulvar lichen sclerosus: study protocol of a randomized controlled trial. Arch Gynecol Obstet. 2023 Aug;308(2):643-649. doi: 10.1007/s00404-023-07055-z. Epub 2023 May 5.
- 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.
Volker Viereck, Prof. principal investigator
Department of Gynecology and Obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FotonaSmooth SP® Spectro laser device and Clobetasol propionate 0.05% ointment in people with Chronic Skin Disease and Vulvar Lichen Sclerosus, run by Prof. Dr. Volker Viereck at 1 site in Switzerland.
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 2 inclusion and 6 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 23 Mar 2026. 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 Switzerland. 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?
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?
Clinical Lichen sclerosus score (LS score) (time frame: 6 months). 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 NCT03926299, which also lists 3 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 23 Mar 2026.