Wart; External Genital OrgansPhase 1/2NCT01555112
Safety and Efficacy Study to Test Topical AS101 for External Genital Warts
A Phase 1/2 study testing Topical AS101 in people with Wart; External Genital Organs and Condyloma Acuminata, run by BioMAS Ltd at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether the improved topical ointment formulation, AS101, is safe and effective in the treatment of external genital warts in females. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Wart; External Genital Organs, Condyloma Acuminata
- What is being tested?
- Topical AS101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Jul 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 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 ointment is on their skin;
- All study participants who are sexually active must use a barrier protection method of contraception such as condom in addition to another birth control measure such as oral contraceptives, intrauterine device, spermicide or surgical sterilization during treatment and for 60 days after completion of treatment;
- Patients with first 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;
- A minimum of one lesion and a maximum of 10 lesions identified at study entry, and the maximum diameter of the largest wart is no larger than 10 mm;
- Papanicolaou smears must be obtained in all females within 12 months of Day 1 and be negative for evidence of high grade intraepithelial neoplasia. Women with high grade intraepithelial neoplasia on cytology will be eligible if subsequent colposcopy with biopsy of suspicious area is negative for high grade squamous intraepithelial lesions (Grade 2 or 3). Atypia, HPV effect, and low grade intraepithelial lesions (Grade 1) are acceptable.
Who cannot join
- Participation in an investigational trial within 30 days prior to Day 1;
- Use of systemic steroids within 30 days of Day 1;
- Previous participation in a trial investigating AS101 for any indication.
- Any prior treatment for genital warts prior to participation;
- Topical and systemic immunosuppressive or immunomodulatory medications (including corticosteroids) within 30 days prior Day 1, and while on study;
- Known history of HIV, HBV and HCV viral infection.
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- Current active infection with herpes genitalis or history of herpes genitalis infection within the last 30 days prior to Day 1 (patients on long-term suppressive antiviral therapy are eligible);
- Current and/or recurrent pathologically relevant genital infections other than genital warts;
- Diagnosis of high-grade cervical dysplasia;
- Internal anogenital, vaginal, urethral and cervical warts requiring treatment;
- Chronic or acute skin condition that might interfere with the evaluation of the treatment or study drug effect;
- Cutaneous surgery, including cryosurgery, to genital area within 30 days of Day 1;
- Screening laboratory tests results from a complete blood count (CBC), chemistry panel, urine pregnancy test and urinalysis obtained during screening (Day -14 to Day 0):
- 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 autoimmune disease;
- Pregnant or lactating;
- Current drug or alcohol abuse that may interfere with the objectives of the study;
- Known allergy to AS101 or any component of the investigational formulation;
- 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 in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II, Open Labeled, Uncontrolled, Single Center Study of Topical AS101 for External Genital Warts
The purpose of this study is to determine whether the improved topical ointment formulation, AS101, is safe and effective in the treatment of external genital warts in females.
Read the detailed description
Human papillomavirus (HPV)-induced condyloma acuminata (CA), commonly known as anogenital or genital warts, is among the most common sexually transmitted diseases. There are a wide variety of available treatments of genital warts, but none are considered completely effective. It has been suggested that AS101 works by stimulating the innate and acquired arms of the immune system.
In previous proof-of-concept clinical study AS101 topical cream was tested on HPV warts and shown cure in high percentages. However the cream formulation was unstable therefore a new formulation was developed mainly for the carrier. In this study the improved AS101 ointment will be tested in female patients with external genital warts in an open study to assess its safety and efficacy.
- Conditions
- Wart; External Genital Organs, Condyloma Acuminata
- Being tested
- Topical AS101
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical AS101Drug
AS101 15% ointment will be applied topically twice daily on external genital warts for up to 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Topical AS101 | Experimental | 15% AS101 ointment applied twice a day for treatment of external genital warts. Receives: Drug: Topical AS101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with Adverse Events and their severity
Measured: up to 16 weeks
Secondary outcomes (5)
Number of patients with complete and partial clearance of external genital warts
Measured: 16 weeks
Number of warts that were completely or partially cleared
Measured: 16 weeks
Time to complete clearance
Measured: 16 weeks
Recurrence rate in treatment area
Measured: 3 months follow up
Time to recurrence
Measured: 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wart; External Genital OrgansStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555112
- Sponsor's protocol ID
- AS101-IL#001
- Status last verified
- Aug 2013
- First submitted
- 11 Mar 2012
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open Labeled, Uncontrolled, Single Center Study of Topical AS101 for External Genital Warts
- ClinicalTrials.gov ID
- NCT01555112
- Acronym / sponsor ID
- AS101-IL#001
- Conditions
- Wart; External Genital Organs, Condyloma Acuminata
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BioMAS LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Mar 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 whether the improved topical ointment formulation, AS101, is safe and effective in the treatment of external genital warts in females.
Detailed description
Human papillomavirus (HPV)-induced condyloma acuminata (CA), commonly known as anogenital or genital warts, is among the most common sexually transmitted diseases. There are a wide variety of available treatments of genital warts, but none are considered completely effective. It has been suggested that AS101 works by stimulating the innate and acquired arms of the immune system.
In previous proof-of-concept clinical study AS101 topical cream was tested on HPV warts and shown cure in high percentages. However the cream formulation was unstable therefore a new formulation was developed mainly for the carrier. In this study the improved AS101 ointment will be tested in female patients with external genital warts in an open study to assess its safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical AS101 | Experimental | Drug: Topical AS10115% AS101 ointment applied twice a day for treatment of external genital warts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women 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 ointment is on their skin;
- All study participants who are sexually active must use a barrier protection method of contraception such as condom in addition to another birth control measure such as oral contraceptives, intrauterine device, spermicide or surgical sterilization during treatment and for 60 days after completion of treatment;
- Patients with first 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;
Key exclusion criteria (23 listed)
- Participation in an investigational trial within 30 days prior to Day 1;
- Use of systemic steroids within 30 days of Day 1;
- Previous participation in a trial investigating AS101 for any indication.
- Any prior treatment for genital warts prior to participation;
- Topical and systemic immunosuppressive or immunomodulatory medications (including corticosteroids) within 30 days prior Day 1, and while on study;
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 |
|---|---|---|
| Topical AS101AS101 15% ointment will be applied topically twice daily on external genital warts for up to 16 weeks. | Drug | Topical AS101 |
Primary outcome
The number of patients with Adverse Events and their severity
Time frame: up to 16 weeks
5 secondary outcomes
Number of patients with complete and partial clearance of external genital warts
Time frame: 16 weeks
Number of warts that were completely or partially cleared
Time frame: 16 weeks
Time to complete clearance
Time frame: 16 weeks
Recurrence rate in treatment area
Time frame: 3 months follow up
Time to recurrence
Time frame: 3 months follow up
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 15 Aug 2013.
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, Afula, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Topical AS101 in people with Wart; External Genital Organs and Condyloma Acuminata, run by BioMAS Ltd at 1 site 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 7 inclusion and 23 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 15 Aug 2013. 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 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. 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?
The number of patients with Adverse Events and their severity (time frame: up to 16 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 15 Aug 2013.