Clinical Trial Search

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: Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer — 0; 1.2 incidence rate per 100…

Primary: Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study — 0.0; 0.4…

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

Primary: Incidence of Objective Response — 32; 36; 30; 0 Participants — p=0.043

Primary: Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12 — 2; 5; 2; 10 Participants

Primary: Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL) — 0.515 proportion of participants

Primary: Number of Participants With Related Serious Adverse Events — 0; 0; 0; 0 Participants

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: Recurrence of Cervical Intraepithelial Neoplasia Among HIV-positive Women — 60; 37 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: Feasibility of Intravaginal Use 5-FU and Imiquimod on Alternating Weeks in Women With Biopsy Confirmed High Grade Cervical Squamous Intraepithelial Lesions. — 4; 1…

Primary: Percentage of Participants With Clinical and Histologic Remission — 75 % of participants

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: Number of Participants With Serious Adverse Events — 0; 0; 0; 0 Participants

Primary: Cumulative Rate of Cervical Intraepithelial Neoplasia (CIN2+) (CIN2, CIN3 or Invasive Cancer) by Week 130 — 24.9; 26.5 Events per 100 persons

Primary: Histologic Regression — 40; 34.1 percentage of participants

Primary: Treatment Schedule A: 12-Week Efficacy, Treatment Schedule B: 13-Week Efficacy — 40.9; 39.1 percentage of patients

Primary: Safety and Toxicity — 0; 0; 0 Participants

Primary: Percentage of Participants With no Histologic Evidence of Anal or Anal/Peri-Anal HSIL and no Evidence of HPV-16/18 at Week 36 — 9.1 percentage of participants — p=0.8633

Primary: Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL) — 3; 0; 7; 3 participants — p=.042

Primary: Global Response Assessment — 5 participants

Primary: Complete Clinical and Pathologic Response — 50 Percentage of Participants

Primary: Change in Wart Number — 0.5 warts

Primary: Pathological Response — 20; 24 participants

Primary: Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24 — 0; 4; 12; 0 participants

Primary: Number of Subjects With Treatment Emergent Adverse Events — 3; 2; 4; 3 Participants

Primary: Complete Response Rate at 3 Months — 39 percentage of participants

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…