Condylomata AcuminataPhase 2NCT03158974
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of External Genital Warts
A Phase 2 study testing East Indian Sandalwood Oil Cream in people with Condylomata Acuminata, run by ViroXis Corporation at 1 site in United States.
Trial summary
This trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and efficacy of VIR007 when administered topically for up to 60 days to adults between the ages of 18 to 65 years with a clinical diagnosis of external condylomata acuminata. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Condylomata Acuminata
- What is being tested?
- East Indian Sandalwood Oil Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 17 Jun 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are ≥18 but ≤65 years of age
- Are in good general health, as confirmed by medical history
- Have a clinical diagnosis of condylomata acuminata with ≥2 but ≤10 visible external genital warts (EGWs)
- Have EGW lesions <200mm2
- Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- Must be willing to use a barrier method of birth control while enrolled in the study.
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- If female of childbearing potential, must have a negative urine pregnancy test result prior to study treatment and must be willing to use a barrier method of birth control while enrolled in the study.
- Are willing to refrain from using any lotions, moisturizer, cleansers, cosmetics or creams, other than those issued as part of the study, on the affected areas during the treatment period.
- Are able to give written informed consent in a manner approved by the Institutional Review Board or Ethics Review Committee and comply with the requirements of the study.
- Are willing to avoid participation in any other clinical trial for the duration of this study.
- Are willing and able to participate as an outpatient, making regularly scheduled visits to the study center during the treatment and to comply with all study requirements including concomitant medication and other treatment restrictions.
- Are willing to forgo all other treatments (prescription, nonprescription, and nutritional supplements) for their EGWs.
Who cannot join
- Have evidence of an active malignancy or have been immunocompromised within the 60 days prior to Screening.
- Received any treatment for their EGW within 60 days of planned study enrollment.
- Are pregnant, breast-feeding, or planning to become pregnant during the study.
- Have EGWs ≥200mm2.
- Have any evidence, currently or in the last 60 days, of herpes genitalis or any other current and/or recurrent genital or uncontrolled infection that, in the opinion of the investigator, could confound the results of the study including human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
- Have any abnormal skin conditions, body piercings, hypertrophic scarring or body modification in the area that, in the opinion of the investigator, might affect the accurate evaluation of EGWs.
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- Shares a household with a subject currently enrolled in the study.
- Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments.
- Have internal genital wart lesions, including the urethra, vagina and/or rectum.
- If female, have any evidence of cervical dysplasia.
- Have evidence of clinically significant or unstable disease (eg, stroke, heart attack).
- Have a known sensitivity to any of the constituents of the test product including sensitivities to sandalwood oil, fragrances or any member of the Compositae family of vascular plants (eg, sunflowers, daisies, dahlias, etc.).
- Have a history of Bowenoid papulosis.
- Have received any of the following within 90 days prior to study treatment:
- Interferon or interferon inducers
- Cytotoxic drugs
- Immunomodulators or immunosuppressive therapies (inhaled/intranasal corticosteroids are permitted)
- Oral or parenteral corticosteroids
- Topical corticosteroids if greater than 2 gm/day
- Any dermatologic procedures or surgeries on the study area (including EGW treatments)
- Have a history of alcohol abuse, or suspected alcohol abuse, in the past two years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Progressive Clinical Research
San Antonio, Texas, 78231
About this study
Official title: A Phase 2, Open-label, Safety, Tolerability, and Efficacy Trial of a Botanical Drug at One Dose Level for the Treatment of External Condylomata Acuminata (Genital Warts) in Adult Immunocompetent Subjects
This trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and efficacy of VIR007 when administered topically for up to 60 days to adults between the ages of 18 to 65 years with a clinical diagnosis of external condylomata acuminata.
Read the detailed description
This trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and efficacy of VIR007 when administered topically for up to 60 days to adults between the ages of 18 to 65 years with a clinical diagnosis of external condylomata acuminata.
Subjects will enter the Screening Period once the informed consent process has been completed. Subjects with a clinical diagnosis of external condylomata acuminata and who meet all inclusion and none of the exclusion criteria will be enrolled.
Once subject eligibility is confirmed and the screening procedures completed, the subject will start the Treatment Period of the study. All enrolled subjects will receive VIR007 (cream containing 10% EISO) with the first dose applied topically during Visit 1 (Day 1). Subjects will be instructed on how to apply the study medication twice daily for up to 60 days or until the Investigator determines the lesions have cleared. Subjects will return to the clinic for study-related assessments on Study Days 7, 14, 28, 42 and a Final Study Visit on Day 60. 30 days following complete resolution, as determined by the study investigator, or, on Study Day 90, subjects will receive a follow-up telephone call and be queried regarding condition status since study completion.
- Conditions
- Condylomata Acuminata
- Being tested
- East Indian Sandalwood Oil Cream
- Keywords
- External Genital Warts
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
East Indian Sandalwood Oil CreamDrug
Also called VIR007
Cream containing 10% East Indian Sandalwood Oil (EISO)/Albuterpenoids
| Study group | Role | What they receive |
|---|---|---|
| VIR007 | Experimental | Cream containing 10% East Indian Sandalwood Oil (EISO)/Albuterpenoids Receives: Drug: East Indian Sandalwood Oil Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.
Measured: 60-days
Secondary outcomes (4)
Incidence of treatment-emergent tolerability issues
Tolerability will be assessed by the number of subjects reporting discomfort either during or immediately following the application of VIR007
Measured: 60-Days
Percentage of patients achieving complete clearance
The percentage of subjects achieving complete clearance of all EGW lesions over the course of the trial
Measured: 60-days
Time to clearance
Time to clearance over the trial
Measured: 60-days
Remission
Percentage of subjects continuing in remission at the follow-up call
Measured: 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 Aug 2017
- Primary completion17 Jun 2018
- Study completion17 Jun 2018
Why it stopped: Sponsor terminated study due to financial constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condylomata AcuminataStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViroXis Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Progressive Clinical Research
- Responsible party
- Sponsor
- Investigators
- Mark Lee, MD, Principal investigator, Progressive Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158974
- Sponsor's protocol ID
- VIR007-01
- Status last verified
- Apr 2021
- First submitted
- 16 May 2017
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Safety, Tolerability, and Efficacy Trial of a Botanical Drug at One Dose Level for the Treatment of External Condylomata Acuminata (Genital Warts) in Adult Immunocompetent Subjects
- ClinicalTrials.gov ID
- NCT03158974
- Acronym / sponsor ID
- VIR007-01
- Conditions
- Condylomata Acuminata
- Keywords
- External Genital Warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated study due to financial constraints.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ViroXis CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Progressive Clinical Research
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 17 Jun 2018 (actual)
- Study completion
- 17 Jun 2018 (actual)
- First posted
- 18 May 2017 (actual)
- 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.
This trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and efficacy of VIR007 when administered topically for up to 60 days to adults between the ages of 18 to 65 years with a clinical diagnosis of external condylomata acuminata.
Detailed description
This trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and efficacy of VIR007 when administered topically for up to 60 days to adults between the ages of 18 to 65 years with a clinical diagnosis of external condylomata acuminata.
Subjects will enter the Screening Period once the informed consent process has been completed. Subjects with a clinical diagnosis of external condylomata acuminata and who meet all inclusion and none of the exclusion criteria will be enrolled.
Once subject eligibility is confirmed and the screening procedures completed, the subject will start the Treatment Period of the study. All enrolled subjects will receive VIR007 (cream containing 10% EISO) with the first dose applied topically during Visit 1 (Day 1). Subjects will be instructed on how to apply the study medication twice daily for up to 60 days or until the Investigator determines the lesions have cleared. Subjects will return to the clinic for study-related assessments on Study Days 7, 14, 28, 42 and a Final Study Visit on Day 60. 30 days following complete resolution, as determined by the study investigator, or, on Study Day 90, subjects will receive a follow-up telephone call and be queried regarding condition status since study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIR007 | Experimental | Drug: East Indian Sandalwood Oil CreamCream containing 10% East Indian Sandalwood Oil (EISO)/Albuterpenoids |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Are ≥18 but ≤65 years of age
- Are in good general health, as confirmed by medical history
- Have a clinical diagnosis of condylomata acuminata with ≥2 but ≤10 visible external genital warts (EGWs)
- Have EGW lesions <200mm2
- Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
Key exclusion criteria (21 listed)
- Have evidence of an active malignancy or have been immunocompromised within the 60 days prior to Screening.
- Received any treatment for their EGW within 60 days of planned study enrollment.
- Are pregnant, breast-feeding, or planning to become pregnant during the study.
- Have EGWs ≥200mm2.
- Have any evidence, currently or in the last 60 days, of herpes genitalis or any other current and/or recurrent genital or uncontrolled infection that, in the opinion of the investigator, could confound the results of the study including human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
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 |
|---|---|---|
| East Indian Sandalwood Oil CreamAlso: VIR007Cream containing 10% East Indian Sandalwood Oil (EISO)/Albuterpenoids | Drug | VIR007 |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 60-days
Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.
4 secondary outcomes
Incidence of treatment-emergent tolerability issues
Time frame: 60-Days
Percentage of patients achieving complete clearance
Time frame: 60-days
Time to clearance
Time frame: 60-days
Remission
Time frame: 90-days
Results and safety
The study was stopped early (reason given: Sponsor terminated study due to financial constraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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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.
Mark Lee, MD principal investigator
Progressive Clinical Trials
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 East Indian Sandalwood Oil Cream in people with Condylomata Acuminata, run by ViroXis Corporation at 1 site in United States.
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 12 inclusion and 21 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: stopped early, as of the sponsor's last update on 3 May 2021. 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 United States. 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 was stopped early (reason given: Sponsor terminated study due to financial constraints.). Results are not available in the source record.
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?
Incidence of treatment-emergent adverse events (time frame: 60-days). 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 3 May 2021.