Clinical trial NCT02849262: Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Condylomata Acuminata (External)
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Leiden University Medical Center
First posted: 2016-07-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Clinical Assessment (Visible Lesions)
timeFrame: 24 Weeks
measure: Clinical Assessment (Percent clearance of treated lesions)
timeFrame: 24 Weeks
measure: Clinical Assessment (Reduction of wart size)
timeFrame: 24 Weeks
measure: Clinical Assessment (PRO)
timeFrame: 24 Weeks
measure: Pharmacodynamics (Local Immunity Status)
timeFrame: 24 Weeks
measure: Pharmacodynamics (HPV Viral Load Assessment)
timeFrame: 24 Weeks
Secondary outcomes:
measure: Safety and Tolerability (e-diary)
timeFrame: 24 Weeks
measure: Safety (AE)
timeFrame: 24 Weeks
measure: Safety (Laboratory Safety Testing)
timeFrame: 24 Weeks
measure: Safety (Treatment-emergent AE and SAE)
timeFrame: 24 Weeks
measure: Safety (Vital Signs)
timeFrame: 24 Weeks
measure: Safety (ECG)
timeFrame: Screening and End of Study
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: LUMC/Centre for Human Drug Research
Study officials:
References:
citation: Rijsbergen M, Rijneveld R, Todd M, Feiss GL, Kouwenhoven STP, Quint KD, van Alewijk DCJG, de Koning MNC, Klaassen ES, Burggraaf J, Rissmann R, van Poelgeest MIE. Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus-induced genital lesions. Br J Clin Pharmacol. 2020 Nov;86(11):2133-2143. doi: 10.1111/bcp.14181. Epub 2020 Sep 28.