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

NCT ID: NCT01286441

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-06-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo for East Indian Sandalwood Oil ointment administered topically twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

10% EISO

East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily

Group Type: ACTIVE_COMPARATOR

10% EISO

Intervention Type: DRUG

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.

20% EISO

East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily

Group Type: ACTIVE_COMPARATOR

20% EISO

Intervention Type: DRUG

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% EISO

East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily

Group Type: ACTIVE_COMPARATOR

30% EISO

Intervention Type: DRUG

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.

Interventions

10% EISO

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

20% EISO

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.

Intervention Type: DRUG

30% EISO

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.

Intervention Type: DRUG

Other Intervention Names

10% East Indian sandalwood oil ointment; sandalwood scented placebo ointment; 20% East Indian sandalwood oil ointment; 30% East Indian sandalwood oil Ointment

Eligibility Criteria

Inclusion Criteria

1. Are male or female, and 18 years of age or older at enrollment;

2. Have 2 to 10 common warts (Verruca vulgaris) to be treated within a single 5 cm-by-5 cm contiguous area (the treatment area);

3. 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;

4. The total surface area of the warts to be treated is ≤600 mm2;

5. 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);

6. Are judged to be in good health based upon the results of a physical examination, medical history, and safety laboratory tests;

7. Are willing and able to provide written informed consent;

8. Agree to use no wart-removing product (prescription or over-the-counter [OTC]) other than the study product during the course of the study;

9. Are willing and able to comply with the requirements of the study;

10. 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.

11. Are willing to refrain from using cosmetics or other topical products in the treatment area for the duration of the study.

Exclusion Criteria

1. Have less than 2 or more than 10 common warts within the designated treatment area;

2. Have warts outside of the treatment area that would interfere with study procedures or analyses;

3. Have participated in an investigational trial within 30 days prior to enrollment;

4. Have participated in a prior trial investigating EISO use for the treatment of common warts;

5. Have used salicylic acid or any over-the-counter wart-removing product in the treatment area within 30 days prior to enrollment;

6. Have used or will use oral zinc and/or cimetidine within 30 days prior to enrollment or during the course of the study;

7. Have received cryotherapy in the treatment area within 60 days prior to enrollment;

8. 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;

9. 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);

10. Have any current uncontrolled infection;

11. Are pregnant, plan to become pregnant, or are breastfeeding;

12. 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.);

13. 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.);

14. Have any active malignancy or are undergoing treatment for any malignancy other than nonmelanoma skin cancer;

15. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ViroXis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rogers, Arkansas, United States

Fremont, California, United States

Lomita, California, United States

Miami, Florida, United States

Arlington Heights, Illinois, United States

Elwood, Indiana, United States

Owensboro, Kentucky, United States

Beverly, Massachusetts, United States

Haverhill, Massachusetts, United States

Fort Gratiot, Michigan, United States

Newington, New Hampshire, United States

Portsmouth, New Hampshire, United States

Rochester, New York, United States

Raleigh, North Carolina, United States

Salisbury, North Carolina, United States

Columbus, Ohio, United States

College Station, Texas, United States

Dallas, Texas, United States

San Antonio, Texas, United States

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

VIR001-01

Identifier Type: -

Identifier Source: org_study_id