Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360705
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-02
Brief Title:
StrataMGT for the Treatment of Vulvar Lichen Sclerosus
Sponsor:
Center for Vulvovaginal Disorders
Organization:
Center for Vulvovaginal Disorders
Study Overview
Official Title:
An Exploratory Open Label Trial of StrataMGT for the Treatment of Vulvar Lichen Sclerosus
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
This study is designed to evaluate the efficacy and safety of StrataMGT for the treatment of vulvar lichen sclerosus
Detailed Description:
This will be an exploratory open label study to evaluate the efficacy and safety of StrataMGT for the treatment of vulvar lichen sclerosus 5 patients with a diagnosis of biopsy proven vulvar lichen sclerosus will be recruited from one center This study will consist of a two-week screening period and an 8-week treatment period At the beginning of the screening period a vulvoscopy will be performed at the screening visit and after the 8-week treatment period to rule out vulvar intraepithelial neoplasia VIN or carcinoma All patients will have a 4mm punch biopsy at screening week 0 and after 8 weeks of treatment week 10
The primary efficacy variable will be performed by a dermatopathologist who will evaluate the inflammatory infiltration on biopsy specimens obtained during the screening period and after treatment at the Week 10 visit 0 to 3 scale
Secondary efficacy endpoints will be change in score on the Vulvar Quality of Life Index VQLI the Skindex 29 and the Clinical Lichen Sclerosus Scoring Scale CLISSCO
The primary efficacy variable will be performed by a dermatopathologist who will evaluate the inflammatory infiltration on biopsy specimens obtained during the screening period and after treatment at the Week 10 visit 0 to 3 scale
Secondary efficacy endpoints will be change in score on the Vulvar Quality of Life Index VQLI the Skindex 29 and the Clinical Lichen Sclerosus Scoring Scale CLISSCO
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None