Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697563
Status:
RECRUITING
Last Update Posted:
2023-07-07
First Post:
2021-01-04
Brief Title:
Laser Therapy in Women With Lichenoid Disorders
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Laser Therapy in Women With Lichenoid Disorders A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Liser
Brief Summary:
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
Detailed Description:
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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None