Common WartsPhase 2NCT01286441

A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for Treatment of Common Warts

A Phase 2 study testing 10% EISO, 20% EISO and 30% EISO in people with Common Warts, run by ViroXis Corporation at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Nonclinical studies have shown sandalwood oil to have anti-inflammatory, anti-fungal, antiviral, and anti-bacterial activities. Previous clinical studies have shown East Indian Sandalwood oil to be promising as a treatment for common warts in adults and children. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Common Warts
What is being tested?: 10% EISO, 20% EISO and 30% EISO
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 183 participants
Where: 20 sitesUnited States
Study dates: Nov 2012to Jun 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Are male or female, and 18 years of age or older at enrollment;
Have 2 to 10 common warts (Verruca vulgaris) to be treated within a single 5 cm-by-5 cm contiguous area (the treatment area);
The treatment area can be located anywhere on the body except for the following prohibited areas: the eye area (including eyelids), lips, mouth cavity, nasal cavity, inner ear, palms of the hands, soles of the feet, or the anogenital area;
The total surface area of the warts to be treated is ≤600 mm2;
If female of childbearing potential, have a negative urine pregnancy test at Screening and Randomization/Day 1, and are willing to use effective contraception during the study (ie, oral, implanted, or injectable contraceptives, intrauterine device (IUD), diaphragm, condom, tubal ligation, abstinence, or are in a monogamous relationship with a partner who has had a vasectomy);
Are judged to be in good health based upon the results of a physical examination, medical history, and safety laboratory tests;

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Are willing and able to provide written informed consent;
Agree to use no wart-removing product (prescription or over-the-counter [OTC]) other than the study product during the course of the study;
Are willing and able to comply with the requirements of the study;
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 AEs.
Are willing to refrain from using cosmetics or other topical products in the treatment area for the duration of the study.

Who cannot join

Have less than 2 or more than 10 common warts within the designated treatment area;
Have warts outside of the treatment area that would interfere with study procedures or analyses;
Have participated in an investigational trial within 30 days prior to enrollment;
Have participated in a prior trial investigating EISO use for the treatment of common warts;
Have used salicylic acid or any over-the-counter wart-removing product in the treatment area within 30 days prior to enrollment;
Have used or will use oral zinc and/or cimetidine within 30 days prior to enrollment or during the course of the study;

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Have received cryotherapy in the treatment area within 60 days prior to enrollment;
Have required or will require systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrollment or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed;
Have any current and/or recurrent pathologically relevant skin infections in the treatment area other than common warts (with the exception of Herpes simplex virus labialis);
Have any current uncontrolled infection;
Are pregnant, plan to become pregnant, or are breastfeeding;
Have a known sensitivity to any of the constituents of the investigational or control products including sandalwood oil, fragrances, or any members of the Compositae family of vascular plants (eg, sunflowers, daisies, dahlias, etc.);
Have any chronic or acute medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk (including human immunodeficiency virus, systemic lupus erythematosis, viral hepatitis, etc.);
Have any active malignancy or are undergoing treatment for any malignancy other than nonmelanoma skin cancer;
Have, in the opinion of the investigator, clinically significant clinical laboratory results at the time of screening that may interfere with the study results or place the subject at undue risk.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Arlington Heights, Illinois, 60005
Study site
Beverly, Massachusetts, 01915
Study site
College Station, Texas, 77845
Study site
Columbus, Ohio, 43231
Study site
Dallas, Texas, 75234
Study site
Elwood, Indiana, 46036
Study site
Fort Gratiot, Michigan, 48059
Study site
Fremont, California, 95438
Study site
Haverhill, Massachusetts, 01830
Study site
Lomita, California, 90717
Study site
Miami, Florida, 33135
Study site
Newington, New Hampshire, 03801
Study site
Owensboro, Kentucky, 42303
Study site
Portsmouth, New Hampshire, 03801
Study site
Raleigh, North Carolina, 27612
Study site
Rochester, New York, 14623
Study site
Rogers, Arkansas, 72758
Study site
Salisbury, North Carolina, 28144
Study site
San Antonio, Texas, 78258
Study site
Virginia Beach, Virginia, 23455

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About this study

Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Dose-ranging, Efficacy and Safety Trial of a New Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) for Treatment of Common Warts (Verruca Vulgaris)

The primary objective of this study is to evaluate the efficacy and safety of 10%, 20%, and 30% East Indian Sandalwood Oil (EISO) ointment compared with the ointment placebo administered twice daily (bid) for 12 weeks for the treatment of common warts (Verruca vulgaris).

Conditions: Common Warts
Being tested: 10% EISO, Placebo, 20% EISO, 30% EISO
Keywords: Verruca vulgaris
Medical subject headings: Warts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

10% EISODrug
Also called 10% East Indian sandalwood oil ointment
During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
PlaceboDrug
Also called sandalwood scented placebo ointment
During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
20% EISODrug
Also called 20% East Indian sandalwood oil ointment
During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
30% EISODrug
Also called 30% East Indian sandalwood oil Ointment
During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.

Study groups in NCT01286441
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo for East Indian Sandalwood Oil ointment administered topically twice daily Receives: Drug: Placebo
10% EISO	Active comparator	East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily Receives: Drug: 10% EISO
20% EISO	Active comparator	East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily Receives: Drug: 20% EISO
30% EISO	Active comparator	East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily Receives: Drug: 30% EISO

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete Resolution of All Treated Warts by or at Week 12
During the Treatment Period, subjects will apply study medication to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks. Clinical evaluations, including wart counts, wart measurements and recording of adverse events and concomitant medications will be performed. Photographs of the treatment area will be taken at all study visits
Measured: 12 weeks

Secondary outcomes (1)

Number of Subjects Achieving Partial Resolution of Treated Warts
Partial Resolution is defined as >/= 75% Reduction of treated wart
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Jun 2014

First posted31 Jan 2011 (estimated)
Study startNov 2012
Primary completionApr 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Common 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01286441
Sponsor's protocol ID: VIR001-01
Status last verified: May 2019
First submitted: 27 Jan 2011
Last updated: 29 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Dose-ranging, Efficacy and Safety Trial of a New Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) for Treatment of Common Warts (Verruca Vulgaris)
ClinicalTrials.gov ID: NCT01286441
Acronym / sponsor ID: VIR001-01
Conditions: Common Warts
Keywords: Verruca vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 183 participants (actual)
Lead sponsor: ViroXis CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Apr 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 31 Jan 2011 (estimated)
Results: Posted 29 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo for East Indian Sandalwood Oil ointment administered topically twice daily
10% EISO	Active comparator	Drug: 10% EISOEast Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily
20% EISO	Active comparator	Drug: 20% EISOEast Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily
30% EISO	Active comparator	Drug: 30% EISOEast Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Are male or female, and 18 years of age or older at enrollment;
Have 2 to 10 common warts (Verruca vulgaris) to be treated within a single 5 cm-by-5 cm contiguous area (the treatment area);
The treatment area can be located anywhere on the body except for the following prohibited areas: the eye area (including eyelids), lips, mouth cavity, nasal cavity, inner ear, palms of the hands, soles of the feet, or the anogenital area;
The total surface area of the warts to be treated is ≤600 mm2;
If female of childbearing potential, have a negative urine pregnancy test at Screening and Randomization/Day 1, and are willing to use effective contraception during the study (ie, oral, implanted, or injectable contraceptives, intrauterine device (IUD), diaphragm, condom, tubal ligation, abstinence, or are in a monogamous relationship with a partner who has had a vasectomy);

Key exclusion criteria (15 listed)

Have less than 2 or more than 10 common warts within the designated treatment area;
Have warts outside of the treatment area that would interfere with study procedures or analyses;
Have participated in an investigational trial within 30 days prior to enrollment;
Have participated in a prior trial investigating EISO use for the treatment of common warts;
Have used salicylic acid or any over-the-counter wart-removing product in the treatment area within 30 days prior to enrollment;

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
10% EISOAlso: 10% East Indian sandalwood oil ointmentDuring the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.	Drug	10% EISO
PlaceboAlso: sandalwood scented placebo ointmentDuring the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.	Drug	Placebo
20% EISOAlso: 20% East Indian sandalwood oil ointmentDuring the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.	Drug	20% EISO
30% EISOAlso: 30% East Indian sandalwood oil OintmentDuring the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.	Drug	30% EISO

Primary outcome

Complete Resolution of All Treated Warts by or at Week 12
Time frame: 12 weeks
During the Treatment Period, subjects will apply study medication to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks. Clinical evaluations, including wart counts, wart measurements and recording of adverse events and concomitant medications will be performed. Photographs of the treatment area will be taken at all study visits

1 secondary outcome

Number of Subjects Achieving Partial Resolution of Treated Warts
Time frame: 12 weeks

Results and safety

Results posted to the registry on 29 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	45	38
10% EISO	44	37
20% EISO	46	39
30% EISO	48	37

Primary outcome: Complete Resolution of All Treated Warts by or at Week 12

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 43	10% EISO n = 42	20% EISO n = 45	30% EISO n = 43
Value	2	5	2	3

Population analysed: FAS population was used for this outcome measure

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Over the entire duration of the treatment and follow up periods (24 WEEKS). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 45 (0%)	3 of 45 (6.7%)	Not reported
10% EISO	1 of 44 (2.3%)	0 of 44 (0%)	Not reported
20% EISO	0 of 46 (0%)	0 of 46 (0%)	Not reported
30% EISO	0 of 48 (0%)	3 of 48 (6.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

20 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 10% EISO, 20% EISO and 30% EISO in people with Common Warts, run by ViroXis Corporation at 20 sites 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 11 inclusion and 15 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 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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. 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?

Yes. Results are posted in the registry (first posted 29 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Resolution of All Treated Warts by or at Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01286441.

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 29 May 2019.