Clinical Trial to Demonstrate That the Dual Laser Therapy is Effective for the Treatment of Vulvar Lichen Sclerosus
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|ClinicalTrials.gov Identifier: NCT03926299|
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Skin Disease Vulvar Lichen Sclerosus||Device: FotonaSmooth SP® Spectro laser device Drug: Clobetasol propionate 0.05% ointment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized, active-controlled|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
dual Fotona laser treatment (Nd:YAG and Er:YAG)
Device: FotonaSmooth SP® Spectro laser device
dual laser treatment with thermal Nd:YAG and ablative Er:YAG (Fotona medical device), 4 laser sessions 4-8 weeks apart.
Other Name: Laser therapy
Active Comparator: Topical steroid
clobetasol propionate 0.05% cream
Drug: Clobetasol propionate 0.05% ointment
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)
Other Name: Local steroid therapy
- 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).
- Vulvovaginal symptom questionnaire (VSQ) [ Time Frame: At each visit through study completion, an average of 1 year ]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.
- Symptom strength score [ Time Frame: At each visit through study completion, an average of 1 year ]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).
- Vulvar punch biopsy [ Time Frame: Baseline and at 6 months ]Histological changes
- Photo documentation of vulvar skin [ Time Frame: At each visit through study completion, an average of 1 year ]Changes of visual appearance of vulvar skin
- Patient satisfaction [ Time Frame: At each follow-up visit (6 months and 12 months) ]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
- Pain during treatment (for laser arm only): Visual analog scale (0-10) [ Time Frame: At each laser treatment session (baseline, 1 month, 2 months, 4 months) ]Visual analog scale (0-10)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926299
|Contact: Volker Viereck, Prof.||+41 52 723 firstname.lastname@example.org|
|Principal Investigator:||Volker Viereck, Prof.||Department of Gynecology and Obstetrics|