Clinical Trial Search

Primary: Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators — 1.85; 0.65; 0.65; 0.73 score on…

Primary: Mean Change in Weekly Mean Worst Itch Numeric Rating Score (WI-NRS) — -4.0; -3.5 units on a scale

Primary: Change in SkinDEX-29 Score — -16.83; -5.92 score on a scale — p=0.007

Primary: Percentage of Participants With ITCH4 at Week 12 — 35.7; 40.0 percentage of participants — p=0.737

Primary: Number of Participants With Recurrence of Dysplasia — 5; 8 Participants

Primary: Global Response Assessment — 5 participants

Primary: Diagnostic Accuracy of "Three Rings Vulvoscopy" by the "Vulvoscopy Index" for Detection of Vulvar Dermatosis — 72; 0; 10; 246 Participants — p=0.6108

Primary: The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6. — 2.4; 2.45; 1.6; 2.27…

Primary: Self-reported Pain Scores Using 100m Visual Analog Scale 0-100 Pain Score. — 6.4; 12.3 mm

Primary: The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared…

Primary: Visible Changes to the Vulva, Vestibule and Vaginal Region on Photography — 8 points improvement on VGTA scale — p=0.05

Primary: Pain Score During the Tampon Test — 4.37; 3.75; 4.04; 4.36 score on a scale — p=0.3630

Primary: Response Rate — .35; .22 proportion of participants

Primary: Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS) — 11.0 score on a scale

Primary: Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness — -1.22; -1.26; -0.84 Units on a scale

Primary: Change in Lichen Planopilaris Activity Index (LLPAI) — -42.9; -66.7 percentage of change from baseline — p=0.014

Primary: Flow Mediated Dilatation (FMD)-Diameter of Artery — 3.79; 3.78 mm

Primary: Co-Primary Efficacy Endpoint - Vaginal Superficial Cells — 17.50; 16.72; 23.20; 5.63 percentage of vaginal superficial cells — p=< 0.0001

Primary: Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples — 15.0; 37.5 percentage of…

Primary: Change From Baseline to Week 12 in the Severity of Vaginal Dryness — 15; 13; 13; 9 Participants — p==0.304

Primary: Change in Oral Sensitivity — -4.5; -6.0 score on a scale

Primary: Percentage of Subjects Identified as Responders — 36.8; 32.0; 0.8 percentage of responders

Primary: Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score — 2.15; 0.73 Scores on a scale — p=0.004

Primary: Number of Participants With Endometrial Biopsy Results at Final Visit — 3; 10; 7; 166 Participants

Primary: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value — 66.52; 66.52; 66.22; 67.03 FVC %-pred — p=0.24

Primary: Number of Participants Experiencing a Serious Adverse Event (SAE). — 0; 0 Participants

Primary: Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit — 2.49; 2.46; 2.50; 2.50 score on a scale

Primary: Complete Resolution of Labial Adhesion. — 21; 22 Participants — p=0.206

Primary: Change in Patient-Reported Itch — -0.33 units on a scale

Primary: Vaginal Wall Composition: Epithelium (Intention to Treat) — 413.9; 314.1 microns — p=0.21