Anogenital WartsPhase 1/2NCT01532102
Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts
A Phase 1/2 study testing AP611074 in people with Anogenital Warts and Condylomata Acuminata, run by Anaconda Pharma at 4 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety, tolerability and efficacy of the topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human papillomavirus (HPV). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anogenital Warts, Condylomata Acuminata, Human Papillomavirus Infection
- What is being tested?
- AP611074
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 28 Feb 2012to 6 May 2013
- Phase
- Phase 1/2
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Main Inclusion Criteria:
- Male or female patient aged between 18 and 55 years.
- External condylomas, 1-15 lesions, non-confluent and individually isolated.
- Lesions must not be internal (ie, they must not penetrate the urethral meatus, vagina or anal canal); their visualization must be complete by patients and investigators without major facilitation maneuvers and easily documented by digital pictures.
- Lesions should have a total surface smaller than 5 cm2, and an individual surface smaller than 1 cm2; lesions should be easily measured using a "French Catheter Scale".
- Lesions to be treated should have appeared between 1-6 months before screening and patients should not have received any previous condyloma treatment since their appearance.
- For patients having previous episodes of condyloma lesions, they shouldn't have received any condyloma treatment for at least 12 months before screening.
Main Exclusion Criteria:
- Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease that, in the Investigator's judgment, prevents the patients from participating to the study.
- Patients with VIN or PIN (intraepithelial neoplasia of vulva or penis; ie, Bowenoid papulosis), or genital disease (ie, lichen sclerosus, lichen planus, lichen simplex chronicus, dermatitis, psoriasis, bullous diseases, systemic diseases with genital manifestations) requiring treatment.
- Patients with fibroepithelial polyps or scaly non-viral papillomas, seborrheic keratosis, follicular papules, syringoma, or circumscribed lymphangiomas.
- Patients whose skin condition or coloration would interfere with the observation and the follow-up of the lesions during the study.
- Patients for whom a proper follow-up of the lesions during the study will not be possible, because of hair growth in the treatment area.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Argentina2 sites
IADT - Instituto Argentino de Diagnostico y Tratamiento S.A.
Buenos Aires, C1122AAL
Hospotal Italinao de Buenos Aires - Dept of Dermatology and Gynecology
Buenos Aires, C1181ACH
France2 sites
Hopital Henri Mondor-Dept of Dermatology
Créteil, 94010
SGS Aster
Paris, 75014
About this study
Official title: A Double-blind, Placebo Controlled, Randomized, Phase IIa Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of Repeated Topical Applications Over 42 Days of AP611074 5% Gel in Condyloma Patients
The purpose of this study is to determine the safety, tolerability and efficacy of the topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human papillomavirus (HPV).
Read the detailed description
Genital warts (GW; also called condylomas or condylomata acuminata) are lesions caused by infection of Human papillomavirus (HPV)(specifically HPV-6 or HPV-11 types, found in > 95% of lesions). GW are sexually transmitted and affect about 1% of the sexually active population. GW represent a distressful condition for social and sexual life, especially in the cases of external condylomas. No HPV-specific antiviral treatment exists to date, and all existing therapies (either surgical or drug) have limited efficacy, with a significant level of GW recurrences and are associated with local skin reactions. AP611074 is a synthetic new chemical entity that is a potent and selective inhibitor of the interaction between two viral proteins from HPV6 and HPV11, an interaction that is a necessary step for HPV DNA replication and thus viral production. AP611074 is the "first in class" specific HPV antiviral described to treat condyloma caused by HPV infection.
- Being tested
- AP611074, Placebo
- Keywords
- Genital warts, Anogenital warts, HPV, Human papillomavirus, Antiviral
- Medical subject headings
- Condylomata Acuminata, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP611074Drug
Also called HPV antiviral, Anticondyloma drug
PlaceboDrug
Placebo gel manufactured to appear identical to AP611074 5% gel
| Study group | Role | What they receive |
|---|---|---|
| AP611074 5% gel | Experimental | Twice daily application of 100 mg dose of AP611074 5% gel for 41 days followed by a single morning application on Day 42 Receives: Drug: AP611074 |
| Placebo gel | Placebo comparator | Twice daily application of 100 mg dose of placebo gel for 41 days followed by a single morning application on Day 42 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment
Measured: 6 weeks
Secondary outcomes (2)
Safety and local tolerability
Descriptive statistics will be calculated by comparing the number of subjects between Day 1 and Day 42 in each treatment group (active or placebo) presenting AEs, or changes in physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory parameters (biochemistry, hematology, urinalysis), and local tolerability (erythema, scaling, stinging, oedema)
Measured: Up to 8 weeks
Pharmacokinetic evaluation
Plasma concentrations of AP611074 will be measured from blood samples once weekly up to 8 weeks in all patients. Data will be summarized with descriptive statistics by nominal sampling time.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study start28 Feb 2012
- Primary completion6 May 2013
- Study completion6 May 2013
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 1/2
- 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
- Anaconda Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olivier Chosidow, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532102
- Sponsor's protocol ID
- AP611074.CT3
- Other IDs
- 2011-003760-80
- Status last verified
- May 2018
- First submitted
- 12 Jan 2012
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo Controlled, Randomized, Phase IIa Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of Repeated Topical Applications Over 42 Days of AP611074 5% Gel in Condyloma Patients
- ClinicalTrials.gov ID
- NCT01532102
- Acronym / sponsor ID
- AP611074.CT3
- Keywords
- Genital warts, Anogenital warts, HPV, Human papillomavirus, Antiviral
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Anaconda PharmaIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2012 (actual)
- Primary completion
- 6 May 2013 (actual)
- Study completion
- 6 May 2013 (actual)
- First posted
- 14 Feb 2012 (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 determine the safety, tolerability and efficacy of the topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human papillomavirus (HPV).
Detailed description
Genital warts (GW; also called condylomas or condylomata acuminata) are lesions caused by infection of Human papillomavirus (HPV)(specifically HPV-6 or HPV-11 types, found in > 95% of lesions). GW are sexually transmitted and affect about 1% of the sexually active population. GW represent a distressful condition for social and sexual life, especially in the cases of external condylomas. No HPV-specific antiviral treatment exists to date, and all existing therapies (either surgical or drug) have limited efficacy, with a significant level of GW recurrences and are associated with local skin reactions. AP611074 is a synthetic new chemical entity that is a potent and selective inhibitor of the interaction between two viral proteins from HPV6 and HPV11, an interaction that is a necessary step for HPV DNA replication and thus viral production. AP611074 is the "first in class" specific HPV antiviral described to treat condyloma caused by HPV infection.
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 |
|---|---|---|
| AP611074 5% gel | Experimental | Drug: AP611074Twice daily application of 100 mg dose of AP611074 5% gel for 41 days followed by a single morning application on Day 42 |
| Placebo gel | Placebo comparator | Drug: PlaceboTwice daily application of 100 mg dose of placebo gel for 41 days followed by a single morning application on Day 42 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| AP611074Also: HPV antiviral, Anticondyloma drug | Drug | AP611074 5% gel |
| PlaceboPlacebo gel manufactured to appear identical to AP611074 5% gel | Drug | Placebo gel |
Primary outcome
Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment
Time frame: 6 weeks
2 secondary outcomes
Safety and local tolerability
Time frame: Up to 8 weeks
Pharmacokinetic evaluation
Time frame: Up to 8 weeks
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 30 May 2018.
Related trials for Anogenital Warts
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Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
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RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
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Not yet recruitingEarly Phase 1
the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
Warts
RecruitingPhase 2
To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years
HPV Infection, HPV-Related Carcinoma
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.
Olivier Chosidow, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AP611074 in people with Anogenital Warts and Condylomata Acuminata, run by Anaconda Pharma at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Argentina, France. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment (time frame: 6 weeks). 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 30 May 2018.