NCT01286441

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: ViroXis Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.
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.
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.

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-04-01
• Completion: 2014-06-01
• First posted: 2011-01-31
• Last updated: 2019-05-29
• Results posted: 2019-05-29

Locations

20 sites across 1 country: United States