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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03158974
Recruitment Status : Recruiting
First Posted : May 18, 2017
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
Progressive Clinical Research
Information provided by (Responsible Party):
ViroXis Corporation

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.

Condition or disease Intervention/treatment Phase
Condylomata Acuminata Drug: VIR007 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Warts Warts

Arm Intervention/treatment
Experimental: VIR007
Cream containing 10% EISO
Drug: VIR007
Cream




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: 60-days ]
    Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.


Secondary Outcome Measures :
  1. Incidence of treatment-emergent tolerability issues [ Time Frame: 60-Days ]
    Tolerability will be assessed by the number of subjects reporting discomfort either during or immediately following the application of VIR007

  2. Percentage of patients achieving complete clearance [ Time Frame: 60-days ]
    The percentage of subjects achieving complete clearance of all EGW lesions over the course of the trial

  3. Time to clearance [ Time Frame: 60-days ]
    Time to clearance over the trial

  4. Remission [ Time Frame: 90-days ]
    Percentage of subjects continuing in remission at the follow-up call



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Are ≥18 but ≤65 years of age
  2. Are in good general health, as confirmed by medical history
  3. Have a clinical diagnosis of condylomata acuminata with ≥2 but ≤10 visible external genital warts (EGWs)
  4. Have EGW lesions <200mm2
  5. 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.
  6. Must be willing to use a barrier method of birth control while enrolled in the study.
  7. 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.
  8. 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.
  9. 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.
  10. Are willing to avoid participation in any other clinical trial for the duration of this study.
  11. 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.
  12. Are willing to forgo all other treatments (prescription, nonprescription, and nutritional supplements) for their EGWs.

Exclusion Criteria:

  1. Have evidence of an active malignancy or have been immunocompromised within the 60 days prior to Screening.
  2. Received any treatment for their EGW within 60 days of planned study enrollment.
  3. Are pregnant, breast-feeding, or planning to become pregnant during the study.
  4. Have EGWs ≥200mm2.
  5. 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.
  6. 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.
  7. Shares a household with a subject currently enrolled in the study.
  8. Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments.
  9. Have internal genital wart lesions, including the urethra, vagina and/or rectum.
  10. If female, have any evidence of cervical dysplasia.
  11. Have evidence of clinically significant or unstable disease (eg, stroke, heart attack).
  12. 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.).
  13. Have a history of Bowenoid papulosis.
  14. Have received any of the following within 90 days prior to study treatment:

    • Interferon or interferon inducers
    • Cytotoxic drugs
    • Immunomodulators or immunosuppressive therapies (inhaled/intranasal corticosteroids are permitted)
    • Oral or parenteral corticosteroids
    • Topical corticosteroids if greater than 2 gm/day
    • Any dermatologic procedures or surgeries on the study area (including EGW treatments)
  15. Have a history of alcohol abuse, or suspected alcohol abuse, in the past two years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158974


Contacts
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Contact: Jeannette Cruz (210) 614-5557 jcruz@progclin.com

Locations
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United States, Texas
Progressive Clinical Research Recruiting
San Antonio, Texas, United States, 78231
Contact: Jeanette Cruz    210-614-5557    info@progclin.com   
Principal Investigator: Mark Lee, MD         
Sponsors and Collaborators
ViroXis Corporation
Progressive Clinical Research
Investigators
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Principal Investigator: Mark Lee, MD Progressive Clinical Trials

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Responsible Party: ViroXis Corporation
ClinicalTrials.gov Identifier: NCT03158974     History of Changes
Other Study ID Numbers: VIR007-01
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ViroXis Corporation:
External Genital Warts

Additional relevant MeSH terms:
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Condylomata Acuminata
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases