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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02849262
• Date of registration: 27/07/2016
• Prospective Registration: No
• Primary sponsor: Cutanea Life Sciences, Inc.
• Public title: Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts
• Scientific title: A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Parallel-Group Study to Explore the Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts
• Date of first enrolment: July 2016
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02849262
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Netherlands

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Condylomata Acuminata (External)

Intervention(s)

Drug: Omiganan (CLS001) topical gel

Drug: Vehicle topical gel

Primary Outcome(s)

Clinical Assessment (Percent clearance of treated lesions) [Time Frame: 24 Weeks]

Pharmacodynamics (Local Immunity Status) [Time Frame: 24 Weeks]

Clinical Assessment (PRO) [Time Frame: 24 Weeks]

Pharmacodynamics (HPV Viral Load Assessment) [Time Frame: 24 Weeks]

Clinical Assessment (Visible Lesions) [Time Frame: 24 Weeks]

Clinical Assessment (Reduction of wart size) [Time Frame: 24 Weeks]

Secondary Outcome(s)

Safety (Laboratory Safety Testing) [Time Frame: 24 Weeks]

Safety (Vital Signs) [Time Frame: 24 Weeks]

Safety and Tolerability (e-diary) [Time Frame: 24 Weeks]

Safety (ECG) [Time Frame: Screening and End of Study]

Safety (AE) [Time Frame: 24 Weeks]

Safety (Treatment-emergent AE and SAE) [Time Frame: 24 Weeks]

Secondary ID(s)

CLS001-CO-PR-011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Leiden University Medical Center