Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-07-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Lenalidomide With Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma

NCT00179712

Ovarian Cancer

COMPLETED PHASE1/PHASE2

Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

NCT01935934

Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Mixed Cell Adenocarcinoma +7 more

COMPLETED PHASE2

Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer

NCT01652794

Leydig Cell Tumor Ovarian Sarcoma Ovarian Stromal Cancer +10 more

COMPLETED PHASE1

Mirvetuximab Soravtansine and Rucaparib Camsylate in Treating Participants With Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer

NCT03552471

BRCA1 Gene Mutation BRCA2 Gene Mutation Folate Receptor Alpha Positive +7 more

COMPLETED PHASE1

A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Ovarian Cancer

NCT05801783

Ovarian Cancer Peritoneal Carcinomatosis Fallopian Tube Cancer

RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Usual Type Vulval Intraepithelial Neoplasia (uVIN)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Omiganan (CLS001)

CLS001 topical gel, 2.5%

Group Type EXPERIMENTAL

Omiganan (CLS001) topical gel

Intervention Type DRUG

Vehicle

Vehicle topical gel

Group Type PLACEBO_COMPARATOR

Vehicle topical gel

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omiganan (CLS001) topical gel

Intervention Type DRUG

Vehicle topical gel

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Women ≥ 18 years
2. Biopsy proven uVIN, biopsies to have been taken within the last three months
3. Written informed consent to participate in the trial
4. At least one lesion that can be accurately measured (using RECIST criteria)

* in at least one dimension with longest diameter ≥ 20mm
* OR in two perpendicular dimensions that when multiplied together give a surface area of ≥ 120mm2 (e.g. 15mm x 8mm or 12mm x 10mm)
* This is to ensure that 4x4mm biopsies can be performed on this lesion.

Exclusion Criteria

1. Has any concomitant disease or significant medical conditions that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial.
2. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) or ECG. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
3. Indication of a current active infectious disease of the vulva, other than HPV
4. Pregnant, breast feeding or trying to conceive
5. Active treatment for uVIN (i.e. surgical excision, lasertherapy, imiquimod, photodynamic therapy) within the previous month
6. Patients receiving immunosuppressive therapy
7. HIV positive or transplant patients
8. Any condition that in the opinion of the investigator could interfere with the conduct of the study

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No