Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts

Maruho

Status and phase: Completed; Phase 2

Conditions: Condylomata Acuminata (External)

Treatments: Drug: Omiganan (CLS001) topical gel; Drug: Vehicle topical gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02849262

CLS001-CO-PR-011

Details and patient eligibility

About

The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan in patients with external genital warts.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female subjects ≥ 18 years of age, with external genital warts. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than genital warts following a detailed medical history and a complete physical examination including vital signs and 12-lead 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.
2. Clinically diagnosed and biopsy confirmed external genital warts. Subject has at least 3 external genital warts.
3. Willing to give written informed consent and willing and able to comply with the study protocol.

Exclusion criteria

Eligible subjects must meet none of the following exclusion criteria at screening:

1. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results including haematology, blood chemistry panel, virology or urinalysis. 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.
2. Current clinically significant skin conditions in the anogenital area (e.g. atopic dermatitis, lichen sclerosus, lichen planus or psoriasis).
3. Pregnant, breast feeding or trying to conceive.
4. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
5. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
6. Use of active treatment (i.e. cryotherapy, laser therapy, topical medication and/or surgical treatments) for genital warts within 28 days prior to first study drug administration.
7. Immunosuppressed patients, having an immunodeficiency (primary or secondary, like HIV) or receiving immunosuppressive therapy (i.e. Transplant patients).
8. Males or Females who received a vaccination with Gardasil or Cervarix.
9. Any (medical) condition 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Omiganan (CLS001)

Experimental group

Description:

CLS001 Topical Gel, 2.5%

Treatment:

Drug: Omiganan (CLS001) topical gel

Vehicle

Placebo Comparator group

Description:

Vehicle Topical Gel

Treatment:

Drug: Vehicle topical gel