Lichen Planus Clinical Trial
Official title:
Laser Therapy in Women With Lichenoid Disorders: A Randomized Controlled Trial
Primary aim of the trial is to compare improvement of lichen symptoms according to a composite VAS scale (burning, itching and pain) between women with vulvovaginal laser therapy vs. sham laser therapy at three months.
Background: Lichenoid Disorders (LD) include VLS (Vulvar lichen sclerosus) and LP (Lichen planus). VLS and LP are chronic skin diseases that usually affect the anogenital region. Both can cause vulvar itching, burning and pain and can lead to urinary and sexual dysfunction. Current treatment options are unsatisfactory. Vulvovaginal laser therapy might be an effective treatment option. Study aim: To study the effectiveness of non-ablative vulvovaginal laser therapy for women with lichenoid disorders. Design: Randomized double-blinded placebo- controlled clinical study Study Population: Women diagnosed with LD will be recruited from a specialized University outpatient clinic. Study groups: Participants will be randomized (1:1). Intervention group: Laser therapy (2 treatments), plus ongoing therapy Control group: Sham laser therapy (2 treatments) plus ongoing therapy Sample size Total 40 patients Primary study outcome: Visual analogue scale (VAS) composite score in regard to LD Secondary study outcomes: quality of life (QoL) (Skindex questionnaire); Treatment discomfort/ pain (VAS); Patient treatment satisfaction (Questionnaire to ask for treatment satifsaction: ZUF-8); Subjective improvement (Patient global impression of improvement- PGI-I), clinical LS score, histological appearance ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06021405 -
Koebner's Phenomenon in Psoriasis and Lichen Planus
|
N/A | |
| Recruiting |
NCT03340155 -
Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
|
N/A | |
| Completed |
NCT05787925 -
Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level in Patients With Erosive Oral Lichen Planus
|
N/A | |
| Completed |
NCT03630198 -
Pain Outcomes Following Intralesional Corticosteroid Injections
|
Phase 4 | |
| Completed |
NCT04952961 -
Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study
|
N/A | |
| Recruiting |
NCT06451744 -
Cellular and Molecular Biomarkers in Patients With Lichen Planus
|
N/A | |
| Completed |
NCT03265093 -
Use of Injectable Platelet Rich Fibrin in Lichen Planus
|
N/A | |
| Completed |
NCT03858634 -
A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
|
Phase 2 | |
| Completed |
NCT02761122 -
Implication of Human Papillomavirus (HPV) in Lichen Physiopathology in Human (HPVLichen)
|
N/A | |
| Active, not recruiting |
NCT00691106 -
A Multi-center Study to Evaluate the Safety of Etanercept in the Treatment of Lichen Planus
|
Phase 2 | |
| Terminated |
NCT05761158 -
Study of the Characteristics of Pruritus in Patients With Frontal Fibrosing Alopecia or Lichen Planus Pilaris
|
||
| Recruiting |
NCT02261662 -
Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection
|
N/A | |
| Not yet recruiting |
NCT04892381 -
Assessment of PD-1 and PD-L1Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study
|
||
| Completed |
NCT05396261 -
a Flexible Wound Dressing for the Management of Genital Skin Conditions
|
N/A | |
| Recruiting |
NCT02532166 -
Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus
|
N/A | |
| Recruiting |
NCT06327620 -
Treatment Of Oral Lichen Planus
|
N/A | |
| Completed |
NCT03796806 -
Methods Validation Assessment for Study of Inflammatory Skin Disease
|
||
| Completed |
NCT02850601 -
Dexamethasone Solution for the Treatment of Oral Lichen Planus
|
Phase 2 | |
| Not yet recruiting |
NCT01041625 -
Pilot Study of Apremilast (CC-10004) in the Treatment of Moderate to Severe Lichen Planus
|
Phase 2 | |
| Completed |
NCT00824889 -
Exploratory Study of Natural Killer Cells in Human Skin
|
N/A |