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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01286441
Recruitment Status : Completed
First Posted : January 31, 2011
Results First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
ViroXis Corporation

Tracking Information
First Submitted Date  ICMJE January 27, 2011
First Posted Date  ICMJE January 31, 2011
Results First Submitted Date  ICMJE April 10, 2019
Results First Posted Date  ICMJE May 29, 2019
Last Update Posted Date May 29, 2019
Study Start Date  ICMJE November 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2011)
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 ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
Number of Subjects Achieving Partial Resolution of Treated Warts [ Time Frame: 12 weeks ]
Partial Resolution is defined as >/= 75% Reduction of treated wart
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2011)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for Treatment of Common Warts
Official Title  ICMJE 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)
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Common Warts
Intervention  ICMJE
  • Drug: 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.
    Other Name: 10% East Indian sandalwood oil ointment
  • 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.
    Other Name: sandalwood scented placebo ointment
  • 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.
    Other Name: 20% East Indian sandalwood oil ointment
  • 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.
    Other Name: 30% East Indian sandalwood oil Ointment
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo for East Indian Sandalwood Oil ointment administered topically twice daily
    Intervention: Drug: Placebo
  • Active Comparator: 10% EISO
    East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily
    Intervention: Drug: 10% EISO
  • Active Comparator: 20% EISO
    East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily
    Intervention: Drug: 20% EISO
  • Active Comparator: 30% EISO
    East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily
    Intervention: Drug: 30% EISO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2019)
183
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2011)
180
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01286441
Other Study ID Numbers  ICMJE VIR001-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party ViroXis Corporation
Original Responsible Party Ian Clements, President & Chief Executive Officer, ViroXis Corporation, Inc.
Current Study Sponsor  ICMJE ViroXis Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ViroXis Corporation
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP