Anogenital WartsPhase 2NCT02377999
Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts
A Phase 2 study testing Picato in people with Anogenital Warts, run by LEO Pharma at 1 site in Denmark.
Trial summary
An exploratory open label, single treatment trial of anogenital warts with Picato® repeated up to 2 times with two weeks intervals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anogenital Warts
- What is being tested?
- Picato
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to Nov 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. A clinical diagnosis of external anogenital/perianal warts with at least 2 warts and no more than 20 warts located in one or more of the following anatomic locations:
- In both sexes: inguinal, perineal, and perianal areas
- In men: penis shaft, scrotum, glans penis and foreskin
- In women: on the vulva
- 2. Subjects has a total wart areas of at least 10 mm2, but not more than 500 mm2
- 3. Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment
Who cannot join
- 1. Subject has received any topical and/or destructive treatments for external anogenital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrolment
- 2. Subject suffer from any of the following conditions:
- Known human immunodeficiency virus (HIV) infection
- An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment
- Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment
- Has a dermatological disease (e.g. psoriasis) or skin condition in the wart areas
- 3. Subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to enrollment
- 4. Prior quadrivalent HPV vaccination
Trial locations and contacts
1 site in 1 country.
About this study
An exploratory open label, single treatment trial of anogenital warts with Picato® repeated up to 2 times with two weeks intervals.
Read the detailed description
The purpose of the present trial is to explore the safety, tolerability and efficacy when treating GW with Picato® 0.05% gel. The primary outcome measures will be related to safety and tolerability and consists of severity of any local reactions in the treated area; treatment-related adverse events (AEs) and serious AEs.
- Conditions
- Anogenital Warts
- Being tested
- Picato
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicatoDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment of genetial warts with Picato | Experimental | Not described Receives: Drug: Picato |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incidence and severity of Local Skin Reactions (LSR)
Measured: Measured two weeks after every treatment and final measurement 2 weeks after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anogenital WartsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merete Hædersdal, Professor MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377999
- Sponsor's protocol ID
- EXP-1167
- Status last verified
- May 2017
- First submitted
- 20 Feb 2015
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts
- ClinicalTrials.gov ID
- NCT02377999
- Acronym / sponsor ID
- EXP-1167
- Conditions
- Anogenital Warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Mar 2015 (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.
An exploratory open label, single treatment trial of anogenital warts with Picato® repeated up to 2 times with two weeks intervals.
Detailed description
The purpose of the present trial is to explore the safety, tolerability and efficacy when treating GW with Picato® 0.05% gel. The primary outcome measures will be related to safety and tolerability and consists of severity of any local reactions in the treated area; treatment-related adverse events (AEs) and serious AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of genetial warts with Picato | Experimental | Drug: Picato |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. A clinical diagnosis of external anogenital/perianal warts with at least 2 warts and no more than 20 warts located in one or more of the following anatomic locations:
- 2. Subjects has a total wart areas of at least 10 mm2, but not more than 500 mm2
- 3. Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment
Key exclusion criteria (8 listed)
- 1. Subject has received any topical and/or destructive treatments for external anogenital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrolment
- 2. Subject suffer from any of the following conditions:
- 3. Subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to enrollment
- 4. Prior quadrivalent HPV vaccination
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 |
|---|---|---|
| Picato | Drug | Treatment of genetial warts with Picato |
Primary outcome
Number of incidence and severity of Local Skin Reactions (LSR)
Time frame: Measured two weeks after every treatment and final measurement 2 weeks after last treatment
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 24 Feb 2025.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Anogenital Warts
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the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
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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.
Merete Hædersdal, Professor MD principal investigator
Bispebjerg Hospital
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 Picato in people with Anogenital Warts, run by LEO Pharma at 1 site in Denmark.
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 6 inclusion and 8 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 24 Feb 2025. 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 Denmark. 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. 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?
Number of incidence and severity of Local Skin Reactions (LSR) (time frame: Measured two weeks after every treatment and final measurement 2 weeks after last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2025.