A Phase 2 Trial of East Indian Sandalwood Oil in the Treatment of Common Warts (Verruca Vulgaris)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ViroXis Corporation
ClinicalTrials.gov Identifier:
NCT01286441
First received: January 27, 2011
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Common Warts
Drug: East Indian Sandalwood Oil ointment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel-group, Multicenter, Placebo-controlled Phase 2 Dose-ranging Trial of the Efficacy and Safety of a New Botanical Drug Product Containing East Indian Sandalwood Oil in the Treatment of Common Warts (Verruca Vulgaris)

Resource links provided by NLM:


Further study details as provided by ViroXis Corporation:

Primary Outcome Measures:
  • The primary objective of the study is to evaluate the efficacy and safety of 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). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Secondary objectives are to provide information on recurrence of common warts and to obtain an estimate of systemic exposure to alpha-santalol at steady state. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: November 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo for East Indian Sandalwood Oil ointment administered topically twice daily
Drug: East Indian Sandalwood Oil ointment
During the Treatment Period, subjects will be randomized to one of the four treatment arms and will apply study medication (either placebo, 10% EISO, 20% EISO or 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.
Active Comparator: 10% EISO
East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily
Drug: East Indian Sandalwood Oil ointment
During the Treatment Period, subjects will be randomized to one of the four treatment arms and will apply study medication (either placebo, 10% EISO, 20% EISO or 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.
Active Comparator: 20% EISO
East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily
Drug: East Indian Sandalwood Oil ointment
During the Treatment Period, subjects will be randomized to one of the four treatment arms and will apply study medication (either placebo, 10% EISO, 20% EISO or 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.
Active Comparator: 30% EISO
East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily
Drug: East Indian Sandalwood Oil ointment
During the Treatment Period, subjects will be randomized to one of the four treatment arms and will apply study medication (either placebo, 10% EISO, 20% EISO or 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286441

Locations
United States, Arkansas
Rogers, Arkansas, United States, 72758
United States, California
Fremont, California, United States, 95438
Lomita, California, United States, 90717
United States, Florida
Miami, Florida, United States, 33135
United States, Illinois
Arlington Hts, Illinois, United States, 60005
United States, Indiana
Elwood, Indiana, United States, 46036
United States, Kentucky
Owensboro, Kentucky, United States, 42303
United States, Massachusetts
Beverly, Massachusetts, United States, 01915
Haverhill, Massachusetts, United States, 01830
United States, Michigan
Fort Gratiot, Michigan, United States, 48059
United States, New Hampshire
Newington, New Hampshire, United States, 03801
West Portsmouth, New Hampshire, United States, 03801
United States, New York
Rochester, New York, United States, 14623
United States, North Carolina
Raleigh, North Carolina, United States, 27612
Salisbury, North Carolina, United States, 28144
United States, Ohio
Columbus, Ohio, United States, 43231
United States, Texas
College Station, Texas, United States, 77845
Dallas, Texas, United States, 75234
San Antonio, Texas, United States, 78258
United States, Virginia
Virginia Beach, Virginia, United States, 23455
Sponsors and Collaborators
ViroXis Corporation
  More Information

No publications provided

Responsible Party: ViroXis Corporation
ClinicalTrials.gov Identifier: NCT01286441     History of Changes
Other Study ID Numbers: VIR001
Study First Received: January 27, 2011
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ViroXis Corporation:
Verruca vulgaris

Additional relevant MeSH terms:
Warts
DNA Virus Infections
Neoplasms
Papillomavirus Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014