NCT03158974

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

A Phase 2, Open-label, Safety, Tolerability, and Efficacy Trial of a Botanical Drug at One Dose Level for the Treatment of External Condylomata Acuminata (Genital Warts) in Adult Immunocompetent Subjects

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: ViroXis Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and efficacy of VIR007 when administered topically for up to 60 days to adults between the ages of 18 to 65 years with a clinical diagnosis of external condylomata acuminata.

Detailed description

This trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and efficacy of VIR007 when administered topically for up to 60 days to adults between the ages of 18 to 65 years with a clinical diagnosis of external condylomata acuminata. Subjects will enter the Screening Period once the informed consent process has been completed. Subjects with a clinical diagnosis of external condylomata acuminata and who meet all inclusion and none of the exclusion criteria will be enrolled. Once subject eligibility is confirmed and the screening procedures completed, the subject will start the Treatment Period of the study. All enrolled subjects will receive VIR007 (cream containing 10% EISO) with the first dose applied topically during Visit 1 (Day 1). Subjects will be instructed on how to apply the study medication twice daily for up to 60 days or until the Investigator determines the lesions have cleared. Subjects will return to the clinic for study-related assessments on Study Days 7, 14, 28, 42 and a Final Study Visit on Day 60. 30 days following complete resolution, as determined by the study investigator, or, on Study Day 90, subjects will receive a follow-up telephone call and be queried regarding condition status since study completion.

Conditions

• Condylomata Acuminata

Interventions

Type	Name	Description
DRUG	East Indian Sandalwood Oil Cream	Cream containing 10% East Indian Sandalwood Oil (EISO)/Albuterpenoids

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-06-17
• Completion: 2018-06-17
• First posted: 2017-05-18
• Last updated: 2021-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study