External Genital WartsPhase 2NCT01943630
Safety and Efficacy Double Blind Vehicle Controlled Study of 15% AS101 Gel to Treat External Genital Warts
A Phase 2 study testing 15% AS101 gel in people with External Genital Warts, run by BioMAS Ltd at 4 sites in Israel.
Trial summary
The purpose of this double blind study is to determine whether topical 15% AS101 gel is effective and safe as compared to vehicle in the treatment of external genital warts in women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- External Genital Warts
- What is being tested?
- 15% AS101 gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesIsrael
- Study dates
- Jan 2015to May 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women at least 18 years of age and in good health;
- Must sign an ethics committee approved informed consent form and be able to adhere to study visits and protocol requirements;
- Women must agree to avoid sexual contact while the gel is on their skin;
- All study participants who are sexually active must use a protection method of contraception during treatment and for 60 days after completion of treatment;
- Patients with clinical diagnosis of external genital warts, in the external genitalia including vulva (labia minora and majora), inguinal folds, pubic area, perineum, perianal, or buttocks areas; two or more distinct external genital warts, and wart area to be treated that is equal to or less than 10 cm2.
Who cannot join
- Participation in an investigational trial within 30 days prior to screening;
- Previous participation in a trial investigating AS101 for any indication;
- Topical treatment for genital warts within 14 days of screening;
- Cutaneous surgery, including cryosurgery or laser, to genital area within 30 days of screening;
- Skin irritations of other clinical signs or symptoms associated with prior therapy.
- Topical and systemic immunosuppressive or immunomodulatory medications (including corticosteroids) within 30 days prior to screening, and while on study;
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- Current active infection with herpes genitalis or history of herpes genitalis infection within the last 30 days prior to screening (patients on long-term suppressive antiviral therapy are eligible);
- Diagnosis of high-grade cervical dysplasia;
- Internal anogenital, vaginal, cervical warts or urethral meatal warts requiring treatment;
- Chronic or acute skin condition that might interfere with the treatment or evaluation of study drug effect;
- Screening laboratory tests results from a complete blood count (CBC), chemistry panel and urine pregnancy test obtained during screening:
- Must be within the site laboratory's defined normal reference ranges, and/or according to the Investigator's decision;
- Urine pregnancy test in females of childbearing potential must be negative;
- Inadequate renal function: Serum Creatinine >2.0mg/dL (>2.0 ULN);
- Inadequate liver function: Serum (total) Bilirubin >2 mg/dl or ALT and/or AST greater than two times the upper limit of the reference range.
- Uncontrolled infection or acute severe febrile illness;
- Diagnosed as having uncontrolled cardiovascular, hematological, hepatic, neurological, renal, endocrine, vascular, autoimmune, or gastrointestinal abnormalities or disease;
- Pregnant or lactating;
- Known allergy to AS101 or any component of the investigational formulation; or
- Subjects with any other clinically significant medical condition, psychiatric condition or laboratory abnormality which would, in the judgment of the Investigator, interfere with the subject's ability to participate and comply with the trial.
Trial locations and contacts
4 sites in 1 country.
Israel4 sites, 4 recruiting
- Recruiting
Ha'Emek Medical Center, Department of Gynecology and obstetrics
Afula, 1834111
Shabtai Romano, MD, +972-4-6494331, shabtai_r@clalit.org.il
papillomatrial@gmail.com
- Recruiting
Kaplan Medical Center, Department of Gynecology
Rehovot, 76100
Alon Ben-Arie, MD, 972-8-9441325, Alon_B@clalit.org.il
Papillomatrial@gmail.com
- Recruiting
Ziv Medical Center, Department of Gynecology and obstetrics
Safed, 13100
Inbar Ben-Shachar, MD, 972-4-6828959, Inbar.b@ziv.health.gov.il
Papillomatrial@gmail.com
- Recruiting
Tel-Aviv Sourasky Medical Center, Department of Gynecology
Tel Aviv, 64239
Dan Grisaru, MD PhD, +972-3-6925604, dangr@tlvmc.gov.il
Papillomatrial@gmail.com
About this study
Official title: A Phase II, Multicenter, Randomized, Double Blind, Vehicle Controlled Study Evaluating the Efficacy and Tolerability of AS101 15% Gel for External Genital Warts.
The purpose of this double blind study is to determine whether topical 15% AS101 gel is effective and safe as compared to vehicle in the treatment of external genital warts in women.
Read the detailed description
Females with external genital warts who meet the eligibility criteria will be randomly allocated in a blinded manner in 1:1 ratio to one of the 2 following study arms: (1) AS101 15% gel or (2) Vehicle. The patients will apply the study drug at home once daily (overnight) until complete clearance of external genital warts or for up to 14 weeks (98 days).
During therapy all patients will return to the clinic every 2 weeks plus/minus 3 days of the treatment visit for clinical assessments of the treated area.
At week 6 of treatment the investigator will evaluate the treated area for all patients. If the investigator determines that there is no change in the disease spread area or lesion number compared to Day 1, study therapy is to be discontinued prior to 14 weeks (98 days) of treatment and the patient will be considered as not cleared. Last observation carried forward (LOCF) method will be used to analyze such patients.
Patients who at week 6 were evaluated by the investigator to have a change in the disease spread area or lesion number compared to Day 1, will continue treatment until complete clearance of warts or up to a maximum of 14 weeks (98 days).
Patients who were evaluated during any of the treatment visits with complete clearance will stop to apply the study therapy, continue to be followed once per 4 weeks for 84 days (12 weeks) for safety and recurrence evaluation. Patients who completed treatment with partial clearance or patients who discontinued for reasons of other than complete clearance will be followed 28 days after discontinuation for disease progression and reference to other therapy if was recommended.
Should significant irritation or any other skin adverse reaction occur during the treatment period, study therapy may be held for up to 7 consecutive days on up to two separate occasions.
Unblinding: Patients will be revealed as to the nature of their treatment only after all patients have completed study.
In case of pregnancy or related serious adverse event the nature of the treatment will be revealed to the patient prior to end of study.
If the investigator determines that there is a disease progression in total lesion number or infected wart area size of the Day 1 treated area, study therapy is to be discontinued prior to 98 days of treatment.
- Conditions
- External Genital Warts
- Being tested
- 15% AS101 gel, Vehicle
- Keywords
- HPV condyloma acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15% AS101 gelDrug
Administration of Topical 15% AS101 once a day (overnight)
VehicleDrug
Administration of Vehicle once a day (overnight)
| Study group | Role | What they receive |
|---|---|---|
| AS101 | Active comparator | Topical 15% AS101 gel, once a day (overnight) Receives: Drug: 15% AS101 gel |
| Vehicle | Placebo comparator | Vehicle, Once a day topical application (Overnight) Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of warts and infected area size (absolute and percent) as compared to Day 1.
Measured: within 14 weeks of treatment
Secondary outcomes (5)
Assessment of safety of AS101 15% gel as expressed by the occurence of local topical reactions such as erythema and edema and systemic reactions to the treatment
Measured: within 14 weeks of treatment and 3 months of follow up
In complete responders assessment of time to complete clearance of warts.
Measured: within 14 weeks of treatment
In complete responders assessment of recurrence rate and time to recurrence.
Measured: Within 3 months of follow up post treatment
Collection of patient's satisfaction data from treatment etc.
Measured: within 14 weeks of treatment
Assessment of tolerability to the 15% AS101 gel as expressed by patient's itching and burning reports.
Measured: within 14 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startJan 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for External Genital 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioMAS Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shabtai Romano, MD, Principal investigator, Ha'Emek Medical center, Department of Gynecology & obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943630
- Sponsor's protocol ID
- AS101-IL#002
- Status last verified
- Oct 2016
- First submitted
- 9 Sep 2013
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double Blind, Vehicle Controlled Study Evaluating the Efficacy and Tolerability of AS101 15% Gel for External Genital Warts.
- ClinicalTrials.gov ID
- NCT01943630
- Acronym / sponsor ID
- AS101-IL#002
- Conditions
- External Genital Warts
- Keywords
- HPV condyloma acuminata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BioMAS LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 17 Sep 2013 (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 double blind study is to determine whether topical 15% AS101 gel is effective and safe as compared to vehicle in the treatment of external genital warts in women.
Detailed description
Females with external genital warts who meet the eligibility criteria will be randomly allocated in a blinded manner in 1:1 ratio to one of the 2 following study arms: (1) AS101 15% gel or (2) Vehicle. The patients will apply the study drug at home once daily (overnight) until complete clearance of external genital warts or for up to 14 weeks (98 days).
During therapy all patients will return to the clinic every 2 weeks plus/minus 3 days of the treatment visit for clinical assessments of the treated area.
At week 6 of treatment the investigator will evaluate the treated area for all patients. If the investigator determines that there is no change in the disease spread area or lesion number compared to Day 1, study therapy is to be discontinued prior to 14 weeks (98 days) of treatment and the patient will be considered as not cleared. Last observation carried forward (LOCF) method will be used to analyze such patients.
Patients who at week 6 were evaluated by the investigator to have a change in the disease spread area or lesion number compared to Day 1, will continue treatment until complete clearance of warts or up to a maximum of 14 weeks (98 days).
Patients who were evaluated during any of the treatment visits with complete clearance will stop to apply the study therapy, continue to be followed once per 4 weeks for 84 days (12 weeks) for safety and recurrence evaluation. Patients who completed treatment with partial clearance or patients who discontinued for reasons of other than complete clearance will be followed 28 days after discontinuation for disease progression and reference to other therapy if was recommended.
Should significant irritation or any other skin adverse reaction occur during the treatment period, study therapy may be held for up to 7 consecutive days on up to two separate occasions.
Unblinding: Patients will be revealed as to the nature of their treatment only after all patients have completed study.
In case of pregnancy or related serious adverse event the nature of the treatment will be revealed to the patient prior to end of study.
If the investigator determines that there is a disease progression in total lesion number or infected wart area size of the Day 1 treated area, study therapy is to be discontinued prior to 98 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AS101 | Active comparator | Drug: 15% AS101 gelTopical 15% AS101 gel, once a day (overnight) |
| Vehicle | Placebo comparator | Drug: VehicleVehicle, Once a day topical application (Overnight) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women at least 18 years of age and in good health;
- Must sign an ethics committee approved informed consent form and be able to adhere to study visits and protocol requirements;
- Women must agree to avoid sexual contact while the gel is on their skin;
- All study participants who are sexually active must use a protection method of contraception during treatment and for 60 days after completion of treatment;
- Patients with clinical diagnosis of external genital warts, in the external genitalia including vulva (labia minora and majora), inguinal folds, pubic area, perineum, perianal, or buttocks areas; two or more distinct external genital warts, and wart area to be treated that is equal to or less than 10 cm2.
Key exclusion criteria (20 listed)
- Participation in an investigational trial within 30 days prior to screening;
- Previous participation in a trial investigating AS101 for any indication;
- Topical treatment for genital warts within 14 days of screening;
- Cutaneous surgery, including cryosurgery or laser, to genital area within 30 days of screening;
- Skin irritations of other clinical signs or symptoms associated with prior therapy.
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 |
|---|---|---|
| 15% AS101 gelAdministration of Topical 15% AS101 once a day (overnight) | Drug | AS101 |
| VehicleAdministration of Vehicle once a day (overnight) | Drug | Vehicle |
Primary outcome
Change in number of warts and infected area size (absolute and percent) as compared to Day 1.
Time frame: within 14 weeks of treatment
5 secondary outcomes
Assessment of safety of AS101 15% gel as expressed by the occurence of local topical reactions such as erythema and edema and systemic reactions to the treatment
Time frame: within 14 weeks of treatment and 3 months of follow up
In complete responders assessment of time to complete clearance of warts.
Time frame: within 14 weeks of treatment
In complete responders assessment of recurrence rate and time to recurrence.
Time frame: Within 3 months of follow up post treatment
Collection of patient's satisfaction data from treatment etc.
Time frame: within 14 weeks of treatment
Assessment of tolerability to the 15% AS101 gel as expressed by patient's itching and burning reports.
Time frame: within 14 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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.
Shabtai Romano, MD principal investigator
Ha'Emek Medical center, Department of Gynecology & obstetrics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 15% AS101 gel in people with External Genital Warts, run by BioMAS Ltd at 4 sites in Israel.
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 5 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 1 Nov 2016. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BioMas Ltd (+972-72-2204004, papillomatrial@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of warts and infected area size (absolute and percent) as compared to Day 1. (time frame: within 14 weeks of 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 1 Nov 2016.