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A phase 2, randomized, double-blind, parallel-group study to assess the pharmacodynamics, safety/tolerability and efficacy of topical omiganan in patients with usual type vulvar intraepithelial neoplasia

Primary Objective• To explore the pharmacodynamic effects of topically applied omiganan • To explore the treatment effect of omiganan compared to placebo in uVIN patients Secondary Objectives• To assess safety and tolerability • To explore the…

Pedicled Peritoneum Vaginoplasty in feminizing genital Surgery; implementation according to IDEAL framework

Primary Objective: To assess the safety of the single flap peritoneum vaginoplasty procedure by studying adverse events and complications during, directly after and within 90 days of the operation. Secondary Objectives: - To assess short- (12 weeks…

5-AMINOLEVULINIC ACID PHOTODYNAMIC THERAPY FOR THE TREATMENT OF PREMALIGNANT DISORDERS OF THE VULVA

Primary objective: To assess the efficacy of low dose rate light fractionated aminolevulinic acid-Photodynamic Therapy (ALA-PDT) for treatment of VLS and HSIL. Clinical and histological response. Secondary objectives: Tolerence of ALA-PDT by…

A phase 2, randomized, vehicle-controlled, double-blind study to explore the efficacy, pharmacodynamics and safety of topical ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide in HPV-induced genital lesions of immunocompromised and immunocompetent patients.

Primary Objective• To explore the pharmacodynamics of the ionic contra-viral therapy CLS003 in immunocompromised and immunocompetent patients with benign and premalignant HPV-induced genital lesions.• To evaluate clinical efficacy of CLS003 compared…