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
|Condition or disease||Intervention/treatment||Phase|
|Condylomata Acuminata||Drug: VIR007||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Cream containing 10% EISO
- 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.
- 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
- 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
- Time to clearance [ Time Frame: 60-days ]Time to clearance over the trial
- Remission [ Time Frame: 90-days ]Percentage of subjects continuing in remission at the follow-up call
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
|Contact: Jeannette Cruz||(210) email@example.com|
|United States, Texas|
|Progressive Clinical Research||Recruiting|
|San Antonio, Texas, United States, 78231|
|Contact: Jeanette Cruz 210-614-5557 firstname.lastname@example.org|
|Principal Investigator: Mark Lee, MD|
|Principal Investigator:||Mark Lee, MD||Progressive Clinical Trials|