Clinical trial NCT01286441: A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for Treatment of Common Warts
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Common Warts
Keywords: Verruca vulgaris
Lead sponsor: ViroXis Corporation
Sponsor class: INDUSTRY
First posted: 2011-01-31
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Complete Resolution of All Treated Warts by or at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Subjects Achieving Partial Resolution of Treated Warts
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rogers
country: United States
state: Arkansas
city: Fremont
country: United States
state: California
city: Lomita
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Arlington Heights
country: United States
state: Illinois
city: Elwood
country: United States
state: Indiana
city: Owensboro
country: United States
state: Kentucky
city: Beverly
country: United States
state: Massachusetts
city: Haverhill
country: United States
state: Massachusetts
city: Fort Gratiot
country: United States
state: Michigan
city: Newington
country: United States
state: New Hampshire
city: Portsmouth
country: United States
state: New Hampshire
city: Rochester
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: College Station
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Virginia Beach
country: United States
state: Virginia
Study officials:
References: