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

NCT03158974 | Terminated Phase 2 FDA Drug

• 1 other identifier: VIR007-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Condylomata Acuminata

Keywords

External Genital Warts

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events

  Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.

  60-days

Secondary Outcomes (4)

• Incidence of treatment-emergent tolerability issues

  60-Days

• Percentage of patients achieving complete clearance

  60-days

• Time to clearance

  60-days

• Remission

  90-days

Study Arms (1)

VIR007

EXPERIMENTAL

Cream containing 10% East Indian Sandalwood Oil (EISO)/Albuterpenoids

Drug: East Indian Sandalwood Oil Cream

Interventions

East Indian Sandalwood Oil Cream DRUG

Cream containing 10% East Indian Sandalwood Oil (EISO)/Albuterpenoids

Also known as: VIR007

VIR007

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are ≥18 but ≤65 years of age
• Are in good general health, as confirmed by medical history
• Have a clinical diagnosis of condylomata acuminata with ≥2 but ≤10 visible external genital warts (EGWs)
• Have EGW lesions \<200mm2
• 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 adverse events.
• Must be willing to use a barrier method of birth control while enrolled in the study.
• If female of childbearing potential, must have a negative urine pregnancy test result prior to study treatment and must be willing to use a barrier method of birth control while enrolled in the study.
• Are willing to refrain from using any lotions, moisturizer, cleansers, cosmetics or creams, other than those issued as part of the study, on the affected areas during the treatment period.
• Are able to give written informed consent in a manner approved by the Institutional Review Board or Ethics Review Committee and comply with the requirements of the study.
• Are willing to avoid participation in any other clinical trial for the duration of this study.
• Are willing and able to participate as an outpatient, making regularly scheduled visits to the study center during the treatment and to comply with all study requirements including concomitant medication and other treatment restrictions.
• Are willing to forgo all other treatments (prescription, nonprescription, and nutritional supplements) for their EGWs.

You may not qualify if:

• Have evidence of an active malignancy or have been immunocompromised within the 60 days prior to Screening.
• Received any treatment for their EGW within 60 days of planned study enrollment.
• Are pregnant, breast-feeding, or planning to become pregnant during the study.
• Have EGWs ≥200mm2.
• Have any evidence, currently or in the last 60 days, of herpes genitalis or any other current and/or recurrent genital or uncontrolled infection that, in the opinion of the investigator, could confound the results of the study including human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
• Have any abnormal skin conditions, body piercings, hypertrophic scarring or body modification in the area that, in the opinion of the investigator, might affect the accurate evaluation of EGWs.
• Shares a household with a subject currently enrolled in the study.
• Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments.
• Have internal genital wart lesions, including the urethra, vagina and/or rectum.
• If female, have any evidence of cervical dysplasia.
• Have evidence of clinically significant or unstable disease (eg, stroke, heart attack).
• Have a known sensitivity to any of the constituents of the test product including sensitivities to sandalwood oil, fragrances or any member of the Compositae family of vascular plants (eg, sunflowers, daisies, dahlias, etc.).
• Have a history of Bowenoid papulosis.
• Have received any of the following within 90 days prior to study treatment:
• Interferon or interferon inducers

Sponsors & Collaborators

• ViroXis Corporation: lead
• Progressive Clinical Research: collaborator

Study Sites (1)

Progressive Clinical Research

San Antonio, Texas, 78231, United States

Location

MeSH Terms

Conditions

Condylomata Acuminata

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Lee, MD

  Progressive Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: August 1, 2017
• Primary Completion: June 17, 2018
• Study Completion: June 17, 2018
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)