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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser | Experimental | dual Fotona laser treatment (Nd:YAG and Er:YAG) |
|
| Topical steroid | Active Comparator | clobetasol propionate 0.05% cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FotonaSmooth SP® Spectro laser device | Device | dual laser treatment with thermal Nd:YAG and ablative Er:YAG (Fotona medical device), 4 laser sessions 4-8 weeks apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At each visit through study completion, an average of 1 year |
| Symptom strength score |
| Measure | Description | Time Frame |
|---|---|---|
| Vulvar punch biopsy | Histological changes | Baseline and at 6 months |
| Photo documentation of vulvar skin | Changes of visual appearance of vulvar skin |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Volker Viereck, Prof. | Department of Gynecology and Obstetrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Hospital Frauenfeld | Frauenfeld | Thurgau | 8501 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42384057 | Derived | 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. | |
| 39998969 | Derived | Zivanovic 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. |
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randomized, active-controlled
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|
| Clobetasol propionate 0.05% ointment | Drug | 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) |
|
|
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). |
| At each visit through study completion, an average of 1 year |
| At each visit through study completion, an average of 1 year |
| Patient satisfaction | Satisfaction of the treatment. Levels: 3 = very much better, 2 = much better, 1 = a little better, 0 = no change, -1 = a little worse, -2 = much worse, -3 = very much worse | At each follow-up visit (6 months and 12 months) |
| Pain during treatment (for laser arm only): Visual analog scale (0-10) | Visual analog scale (0-10) | At each laser treatment session (baseline, 1 month, 2 months, 4 months) |
| 37145134 | Derived | Viereck 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. |
| ID | Term |
|---|---|
| D007724 | Vulvar Lichen Sclerosus |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D002990 | Clobetasol |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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