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

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.

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study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations

Study Overview

• Status: Completed
• Conditions: External Anogenital Warts
• Intervention / Treatment: Drug: Podofilox Gel 0.5%; Drug: Condylox Topical Gel 0.5%; Drug: Placebo Gel

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.

• Study Type: Interventional
• Enrollment (Actual): 466
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Chelyabinsk, Russian Federation
    • "Ecology of Health" LLC
  • Chelyabinsk, Russian Federation
    • State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Dermatovenerology Dispensary"
  • Korolev, Russian Federation
    • State autonoumous institution of Healthcare of Moscow region "Korolev Dermatovenerology dispensary"
  • Moscow, Russian Federation
    • "Moscow scientific-practical center of Dermatovenerology and cosmetology"
  • Penza, Russian Federation
    • "Clinic of urology №1" LLC
  • Rostov-on-Don, Russian Federation
    • Rostov State Medical University
  • Smolensk, Russian Federation
    • Regional State-Financed Health Institution of Healthcare "Smolensk Dermatovenerologic dispensary"
  • St. Petersburg, Russian Federation
    • State Budgetary Institution of Healthcare "Dermatovenerologic dispensary #8" of Krasnogvardeyskiy district of Saint Petersburg
• Ukraine
  • Dnipro, Ukraine
    • Medical Center of Private Enterprise "Dzerkalo"
  • Ivano-Frankivs'k, Ukraine
    • Municipal institution "Ivano-Frankivsk Regional Clinical Skin and Venereal Dispensary"
  • Kharkiv, Ukraine
    • Municipal Health Care Institution "Kharkiv City Clinical Dermatovenerologic Dispensary №5"
  • Rivne, Ukraine
    • Municipal Institution "Rivne Regional Dermatology and Venerology Dispensary" of Rivne Regional Council
  • Zaporizhzhya, Ukraine
    • Municipal Institution "Zaporizhzhya Regional Dermatovenerology Clinical Dispensary" of Zaporizhzhya Regional Council
• United States
  • Florida
    • Miami, Florida, United States, 33015
      • Leon Medical Research
    • Miami, Florida, United States, 33143
      • Well Pharma Medical Research Corp
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co, Inc
  • Texas
    • Houston, Texas, United States, 77054
      • TMC Life Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Podofilox Gel 0.5 %; Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles	Drug: Podofilox Gel 0.5%; Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
Active Comparator: Condylox Topical Gel 0.5%; Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles	Drug: Condylox Topical Gel 0.5%; Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
Placebo Comparator: Placebo Gel; Subjects in this arm will receive a vehicle that matches the test product, except for the inclusion of the active ingredient	Drug: Placebo Gel; Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas.	The primary endpoint is the Number and Percentage of subjects in the per protocol (PP) population with "treatment success" defined as "total disappearance of all warts within all treated areas".	28 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.	Local application site reactions scores (erythema, dryness, burning/stinging, erosion, edema, pain, itching and bleeding) in each group during the study drug application period. Other adverse events including serious adverse events throughout the study participation. Local skin reaction scores for erythema, dryness, burning/stinging, erosion, edema, pain, itching and bleeding will be recorded by the Investigator for every study visit based on their intensity. Skin Reaction Scale will be used absent, mild (slight, barely perceptible), moderate (distinct presence) and severe (marked, intense).	28 days (at visit 6)
Analysis of Safety Variables Will be Based on All Adverse Events (AE).	AEs will be summarized based on the frequency of AEs and their severity for all treated subjects.	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.

Collaborators and Investigators

• Sponsor: Dermax SA
• Collaborators: bioRASI, LLC
• Investigators: Study Director: Evgeniy Cherepanov, MD, bioRASI, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2018
• Primary Completion (Actual): December 2, 2018
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Condylomata Acuminata; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Dermatologic Agents; Keratolytic Agents; Podophyllotoxin
• Other Study ID Numbers: 016-POD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes