Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts

Completed · Phase 3 · Has a placebo group

Conditions studied: External Anogenital Warts

In brief

A clinical endpoint bioequivalence (BE) study for a Podofilox Gel 0.5% formulation for the treatment of external anogenital warts in comparison to Condylox® Gel 0.5% that follows the study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations

Key facts

Study ID: NCT03532776
Run by: Dermax SA
People needed: 466
Starts: 2018-04-20
Expected to finish: 2020-01-31
Last updated by the study team: 2021-07-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Willing and able to provide written informed consent prior to participating in this study.
Male or female subjects, aged 18-65 inclusive, with a clinical diagnosis of external anogenital warts (i.e., perianal warts and/or external genital warts), including two or more distinct external genital warts, and wart area that is equal or less than 10 cm2. Histological confirmation should be obtained if there is any doubt of the diagnosis.
Females of childbearing potential may be enrolled if they practice a method of birth control with a reliability of at least 90%.
Sexually active study participants must agree to abstain from sexual activity of any kind throughout the treatment period to prevent cross- and reinfection by HPV.
Any female subject with childbearing potential has a negative urine pregnancy test at Baseline.
Negative HIV test within 4 weeks before Baseline.

You may not qualify if…

Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
Hypersensitivity or intolerance to Podofilox or any component of the formulation.
History of previous unsuccessful treatment with any formulation of Podofilox.
Wart area that is greater than 10 cm2.
Patients with internal anogenital and mucous membrane warts, Bowenoid papulosis, squamous cell carcinoma, active herpes lesion, or other skin abnormalities of treatment area, such as eczema, or skin that had not healed following surgery (cryosurgery, laser ablation or similar).
Primary or secondary immunodeficiency.
Known presence of diabetes type I or II.
Local irritation in any treatment area that would interfere with treatment.
Use within 4 weeks prior to baseline of any: 1) treatment for anogenital warts, 2) systemic corticosteroids, or 3) systemic immunosuppressive drug.
Any medical or surgical condition in the judgment of the Investigator that may interfere with the assessment of efficacy or safety, or pose a risk to the subject.
Patients known to abuse alcohol and/or drugs, or with a history of chronic alcohol or drug abuse that may result in protocol noncompliance.
Received another investigational drug, device or biologic within 90 days prior to the start of Screening or has planned to participate in another clinical trial while enrolled in this study.
Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study
Employee (or employee's family member) of the research center or private practice, CRO or Sponsor, or subjects who have a conflict of interest.
Subjects living (e.g., siblings, spouses, relatives, roommates) in the same household cannot be enrolled in the study at the same time.
Previous enrollment in this study, current enrollment in this study at another participating site or current enrollment in another study (in parallel to this study) at another clinical research site.

Where it is running

Leon Medical Research — Miami, Florida, United States
Well Pharma Medical Research Corp — Miami, Florida, United States
Paddington Testing Co, Inc — Philadelphia, Pennsylvania, United States
TMC Life Research, Inc — Houston, Texas, United States
"Ecology of Health" LLC — Chelyabinsk, Russia
State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Dermatovenerology Dispensary" — Chelyabinsk, Russia
State autonoumous institution of Healthcare of Moscow region "Korolev Dermatovenerology dispensary" — Korolyov, Russia
"Moscow scientific-practical center of Dermatovenerology and cosmetology" — Moscow, Russia
"Clinic of urology №1" LLC — Penza, Russia
Rostov State Medical University — Rostov-on-Don, Russia
State Budgetary Institution of Healthcare "Dermatovenerologic dispensary #8" of Krasnogvardeyskiy district of Saint Petersburg — Saint Petersburg, Russia
Regional State-Financed Health Institution of Healthcare "Smolensk Dermatovenerologic dispensary" — Smolensk, Russia
Medical Center of Private Enterprise "Dzerkalo" — Dnipro, Ukraine
Municipal institution "Ivano-Frankivsk Regional Clinical Skin and Venereal Dispensary" — Ivano-Frankivsk, Ukraine
Municipal Health Care Institution "Kharkiv City Clinical Dermatovenerologic Dispensary №5" — Kharkiv, Ukraine
Municipal Institution "Rivne Regional Dermatology and Venerology Dispensary" of Rivne Regional Council — Rivne, Ukraine
Municipal Institution "Zaporizhzhya Regional Dermatovenerology Clinical Dispensary" of Zaporizhzhya Regional Council — Zaporizhzhya, Ukraine

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.