Patients ≥ 18 years of age with Lichen sclerosis (LS)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Participants will be treated with subcutaneous (SC) nemolizumab injections at doses determined by patient weight.
University of Texas Southwestern Medical Center
Dallas, Texas, United States
A ≥ 4-point improvement in Itch NRS score
Participants are instructed to complete and record the Skin Itch NRS in a diary each night for the first 6 weeks, then at study visits for the duration of treatment. Participants will select a number from 0 (no itch) to 10 (worst itch imaginable).
Time frame: Baseline to Week 24
Time to achieve a ≥4-point Itch NRS reduction
Study team will determine the average length of time it takes to achieve a ≥4-point Itch NRS reduction in study participants.
Time frame: From Baseline to Week 24
Change in Clinical Photographs based on internal physician-rated severity scale
Photos will be taken at baseline, then each study visit to assess disease clinical signs and architecture change
Time frame: Baseline to Week 24
Change in Vulvar Quality of Life Index (VQLI) Score
The VQLI is a 15-question survey used to measure the impact of vulvar conditions on a patient's quality of life. The higher the score, the more significant an impact is present.
Time frame: Baseline to Week 24
Change in Pain NRS score
Participants are instructed to complete and record the Skin Pain NRS in a diary each night for the first 6 weeks, then at study visits for the duration of treatment. Participants will select a number from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline to Week 24
Change in tissue stiffness and induration by measuring the exact force (in Newtons) through SkinFibrometer
Time frame: Baseline to Week 24
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Change in the Clinical Lichen Sclerosus Score (CLISSCO)
This score consists of 12 items in three categories: Symptoms (itch, pain, dysuria); Signs (whitening, petechiae/ecchymosis, fissures); and Architectural changes (clitoral hood fusion, labial fusion or resorption, narrowing of the introitus, anterior changes, perianal involvement, formation of posterior commissure band). Severe disease has a higher score.
Time frame: Baseline to Week 24
Change in Female Sexual Function Index (FSFI) score
The FSFI is a 19-item questionnaire that measures six domains of sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. The higher the score, the more significant impact is present.
Time frame: Baseline to Week 24
Change in Short Health Anxiety Inventory (SHAI) score
The SHAI is an 18-item questionnaire used to measure the severity of health anxiety and illness-related fears. Higher scores indicate greater levels of health anxiety.
Time frame: Baseline to Week 24