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

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Common Warts

Intervention / Treatment
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* Drug: 10% EISO
* Drug: Placebo
* Drug: 20% EISO
* Drug: 30% EISO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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. Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo for East Indian Sandalwood Oil ointment administered topically twice daily | Drug: Placebo<br>* 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.<br>* Other names: sandalwood scented placebo ointment;|
| Active Comparator: 10% EISO<br>East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily | Drug: 10% EISO<br>* 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.<br>* Other names: 10% East Indian sandalwood oil ointment;|
| Active Comparator: 20% EISO<br>East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily | Drug: 20% EISO<br>* 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.<br>* Other names: 20% East Indian sandalwood oil ointment;|
| Active Comparator: 30% EISO<br>East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily | Drug: 30% EISO<br>* 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.<br>* Other names: 30% East Indian sandalwood oil Ointment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Achieving Partial Resolution of Treated Warts | Partial Resolution is defined as >/= 75% Reduction of treated wart | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Verruca vulgaris