Clinical trial NCT03532776: Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo- Controlled, Study of Hyloris Developments' Podofilox Topical Gel 0.5% Compared to Allergan's Condylox® Gel 0.5% in Male and Female Patients With External Anogenital Warts.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: External Anogenital Warts
Lead sponsor: Dermax SA
Sponsor class: INDUSTRY
Collaborators: name: bioRASI, LLC
First posted: 2018-05-22
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations

Detailed description: This is a multicenter, parallel group, randomized, double-blind, placebo-controlled, trial with clinical endpoint comparing Podofilox Topical Gel 0.5% to Condylox® Gel 0.5% and a matching placebo. The study will be conducted among adult male and female patients with external anogenital warts. The Investigator will assess vital signs and perform physical examination identifying any clinically significant abnormalities. Laboratory samples will be collected, including HIV, Hepatitis B\&C, and urine pregnancy tests (UPT) for women of childbearing potential. The Investigator will confirm the diagnosis of External Anogenital Warts (EAW) and the absence of contraindications specified in the exclusion criterion 4 during the visual examination. The biopsy of skin lesions will be performed per the discretion of the Investigator for microscopic verification of the diagnosis of EAWs if any doubts of the diagnosis.

Eligibility criteria: Inclusion Criteria:

1. Willing and able to provide written informed consent prior to participating in this study.
2. 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.
3. Females of childbearing potential may be enrolled if they practice a method of birth control with a reliability of at least 90%.
4. 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.
5. Any female subject with childbearing potential has a negative urine pregnancy test at Baseline.
6. Negative HIV test within 4 weeks before Baseline.

   Exclusion Criteria:
7. Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
8. Hypersensitivity or intolerance to Podofilox or any component of the formulation.
9. History of previous unsuccessful treatment with any formulation of Podofilox.
10. Wart area that is greater than 10 cm2.
11. 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).
12. Primary or secondary immunodeficiency.
13. Known presence of diabetes type I or II.
14. Local irritation in any treatment area that would interfere with treatment.
15. Use within 4 weeks prior to baseline of any: 1) treatment for anogenital warts, 2) systemic corticosteroids, or 3) systemic immunosuppressive drug.
16. 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.
17. Patients known to abuse alcohol and/or drugs, or with a history of chronic alcohol or drug abuse that may result in protocol noncompliance.
18. 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.
19. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study
20. Employee (or employee's family member) of the research center or private practice, CRO or Sponsor, or subjects who have a conflict of interest.
21. Subjects living (e.g., siblings, spouses, relatives, roommates) in the same household cannot be enrolled in the study at the same time.
22. 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.

Primary outcomes:
measure: Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas.
timeFrame: 28 days.
Secondary outcomes:
measure: Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
timeFrame: 28 days (at visit 6)
measure: Analysis of Safety Variables Will be Based on All Adverse Events (AE).
timeFrame: The AE reporting period for this study begins with the signature of the Informed Consent Form and, for unresolved AEs, ends 30 days following the last study medication application, a total of up to 65 days.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Leon Medical Research
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corp
state: Florida
city: Philadelphia
country: United States
facility: Paddington Testing Co, Inc
state: Pennsylvania
city: Houston
country: United States
facility: TMC Life Research, Inc
state: Texas
city: Chelyabinsk
country: Russian Federation
facility: "Ecology of Health" LLC
city: Chelyabinsk
country: Russian Federation
facility: State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Dermatovenerology Dispensary"
city: Korolev
country: Russian Federation
facility: State autonoumous institution of Healthcare of Moscow region "Korolev Dermatovenerology dispensary"
city: Moscow
country: Russian Federation
facility: "Moscow scientific-practical center of Dermatovenerology and cosmetology"
city: Penza
country: Russian Federation
facility: "Clinic of urology №1" LLC
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Smolensk
country: Russian Federation
facility: Regional State-Financed Health Institution of Healthcare "Smolensk Dermatovenerologic dispensary"
city: St. Petersburg
country: Russian Federation
facility: State Budgetary Institution of Healthcare "Dermatovenerologic dispensary #8" of Krasnogvardeyskiy district of Saint Petersburg
city: Dnipro
country: Ukraine
facility: Medical Center of Private Enterprise "Dzerkalo"
city: Ivano-Frankivs'k
country: Ukraine
facility: Municipal institution "Ivano-Frankivsk Regional Clinical Skin and Venereal Dispensary"
city: Kharkiv
country: Ukraine
facility: Municipal Health Care Institution "Kharkiv City Clinical Dermatovenerologic Dispensary №5"
city: Rivne
country: Ukraine
facility: Municipal Institution "Rivne Regional Dermatology and Venerology Dispensary" of Rivne Regional Council
city: Zaporizhzhya
country: Ukraine
facility: Municipal Institution "Zaporizhzhya Regional Dermatovenerology Clinical Dispensary" of Zaporizhzhya Regional Council
Study officials:
affiliation: bioRASI, LLC
name: Evgeniy Cherepanov, MD
role: STUDY_DIRECTOR
References: