Condylomata Acuminata (External)Phase 2NCT02849262
Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts
A Phase 2 study testing Omiganan (CLS001) topical gel in people with Condylomata Acuminata (External), run by Maruho Co., Ltd. at 1 site in Netherlands.
Trial summary
The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan in patients with external genital warts. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Condylomata Acuminata (External)
- What is being tested?
- Omiganan (CLS001) topical gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2016to 21 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Clinically diagnosed and biopsy confirmed external genital warts. Subject has at least 3 external genital warts.
- Willing to give written informed consent and willing and able to comply with the study protocol.
Who cannot join
- Eligible subjects must meet none of the following exclusion criteria at screening:
- 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.
- Current clinically significant skin conditions in the anogenital area (e.g. atopic dermatitis, lichen sclerosus, lichen planus or psoriasis).
- Pregnant, breast feeding or trying to conceive.
- Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
- Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
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- 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.
- Immunosuppressed patients, having an immunodeficiency (primary or secondary, like HIV) or receiving immunosuppressive therapy (i.e. Transplant patients).
- Males or Females who received a vaccination with Gardasil or Cervarix.
- 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 locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan in patients with external genital warts.
- Conditions
- Condylomata Acuminata (External)
- Being tested
- Omiganan (CLS001) topical gel, Vehicle topical gel
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omiganan (CLS001) topical gelDrug
Vehicle topical gelDrug
| Study group | Role | What they receive |
|---|---|---|
| Omiganan (CLS001) | Experimental | CLS001 Topical Gel, 2.5% Receives: Drug: Omiganan (CLS001) topical gel |
| Vehicle | Placebo comparator | Vehicle Topical Gel Receives: Drug: Vehicle topical gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessment (Visible Lesions)
Count of all visible lesions
Measured: 24 Weeks
Clinical Assessment (Percent clearance of treated lesions)
Measured: 24 Weeks
Clinical Assessment (Reduction of wart size)
Includes 2D and 3D photography
Measured: 24 Weeks
Clinical Assessment (PRO)
Change in Patient-reported outcomes
Measured: 24 Weeks
Pharmacodynamics (Local Immunity Status)
Histological changes
Measured: 24 Weeks
Pharmacodynamics (HPV Viral Load Assessment)
Quantitative PCR including HPV genotyping in swabs, qPCR to assess change from baseline, mean HPV viral load at treatment weeks and overall
Measured: 24 Weeks
Secondary outcomes (6)
Safety and Tolerability (e-diary)
Compliance with dosing instructions (patient completed e-diary)
Measured: 24 Weeks
Safety (AE)
Adverse Events will be collected throughout the study
Measured: 24 Weeks
Safety (Laboratory Safety Testing)
Lab samples will be collected throughout the study
Measured: 24 Weeks
Safety (Treatment-emergent AE and SAE)
Treatment-emergent AE and SAE will be collected throughout the study
Measured: 24 Weeks
Safety (Vital Signs)
Vital Signs will be collected throughout the study
Measured: 24 Weeks
Safety (ECG)
ECGs will be collected at before beginning and end of study
Measured: Screening and End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion21 Mar 2017
- Study completion21 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Condylomata Acuminata (External)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849262
- Sponsor's protocol ID
- CLS001-CO-PR-011
- Status last verified
- Mar 2017
- First submitted
- 27 Jul 2016
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31755993
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02849262
- Acronym / sponsor ID
- CLS001-CO-PR-011
- Conditions
- Condylomata Acuminata (External)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Leiden University Medical Center
- Study start
- Jul 2016
- Primary completion
- 21 Mar 2017 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the pharmacodynamics, safety and efficacy of omiganan in patients with external genital warts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omiganan (CLS001) | Experimental | Drug: Omiganan (CLS001) topical gelCLS001 Topical Gel, 2.5% |
| Vehicle | Placebo comparator | Drug: Vehicle topical gelVehicle Topical Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- Clinically diagnosed and biopsy confirmed external genital warts. Subject has at least 3 external genital warts.
- Willing to give written informed consent and willing and able to comply with the study protocol.
Key exclusion criteria (10 listed)
- 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.
- Current clinically significant skin conditions in the anogenital area (e.g. atopic dermatitis, lichen sclerosus, lichen planus or psoriasis).
- Pregnant, breast feeding or trying to conceive.
- Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
- Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omiganan (CLS001) topical gel | Drug | Omiganan (CLS001) |
| Vehicle topical gel | Drug | Vehicle |
Primary outcome
Clinical Assessment (Visible Lesions)
Time frame: 24 Weeks
Count of all visible lesions
Clinical Assessment (Percent clearance of treated lesions)
Time frame: 24 Weeks
Clinical Assessment (Reduction of wart size)
Time frame: 24 Weeks
Includes 2D and 3D photography
Clinical Assessment (PRO)
Time frame: 24 Weeks
Change in Patient-reported outcomes
Pharmacodynamics (Local Immunity Status)
Time frame: 24 Weeks
Histological changes
Pharmacodynamics (HPV Viral Load Assessment)
Time frame: 24 Weeks
Quantitative PCR including HPV genotyping in swabs, qPCR to assess change from baseline, mean HPV viral load at treatment weeks and overall
6 secondary outcomes
Safety and Tolerability (e-diary)
Time frame: 24 Weeks
Safety (AE)
Time frame: 24 Weeks
Safety (Laboratory Safety Testing)
Time frame: 24 Weeks
Safety (Treatment-emergent AE and SAE)
Time frame: 24 Weeks
Safety (Vital Signs)
Time frame: 24 Weeks
Safety (ECG)
Time frame: Screening and End of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Derived from this study: PubMed 31755993Rijsbergen 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omiganan (CLS001) topical gel in people with Condylomata Acuminata (External), run by Maruho Co., Ltd. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Assessment (Visible Lesions) (time frame: 24 Weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02849262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.