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

NCT03532776 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 016-POD-001
• Study Type: interventional
• Target: 466
• Locations: 3 countries
• Sites: 17

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study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations

Conditions

External Anogenital Warts

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.

  28 days (at visit 6)

• Analysis of Safety Variables Will be Based on All Adverse Events (AE).

  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.

Study Arms (3)

Podofilox Gel 0.5 %

EXPERIMENTAL

Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles

Drug: Podofilox Gel 0.5%

Condylox Topical Gel 0.5%

ACTIVE COMPARATOR

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%

Placebo Gel

PLACEBO COMPARATOR

Subjects in this arm will receive a vehicle that matches the test product, except for the inclusion of the active ingredient

Drug: Placebo Gel

Interventions

Podofilox Gel 0.5% DRUG

Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles

Podofilox Gel 0.5 %

Condylox Topical Gel 0.5% DRUG

Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles

Condylox Topical Gel 0.5%

Placebo Gel DRUG

Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles

Placebo Gel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Dermax SA: lead
• bioRASI, LLC: collaborator

Study Sites (17)

Leon Medical Research

Miami, Florida, 33015, United States

Location

Well Pharma Medical Research Corp

Miami, Florida, 33143, United States

Location

Paddington Testing Co, Inc

Philadelphia, Pennsylvania, 19103, United States

Location

TMC Life Research, Inc

Houston, Texas, 77054, United States

Location

"Ecology of Health" LLC

Chelyabinsk, Russia

Location

State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Dermatovenerology Dispensary"

Chelyabinsk, Russia

Location

State autonoumous institution of Healthcare of Moscow region "Korolev Dermatovenerology dispensary"

Korolyov, Russia

Location

"Moscow scientific-practical center of Dermatovenerology and cosmetology"

Moscow, Russia

Location

"Clinic of urology №1" LLC

Penza, Russia

Location

Rostov State Medical University

Rostov-on-Don, Russia

Location

State Budgetary Institution of Healthcare "Dermatovenerologic dispensary #8" of Krasnogvardeyskiy district of Saint Petersburg

Saint Petersburg, Russia

Location

Regional State-Financed Health Institution of Healthcare "Smolensk Dermatovenerologic dispensary"

Smolensk, Russia

Location

Medical Center of Private Enterprise "Dzerkalo"

Dnipro, Ukraine

Location

Municipal institution "Ivano-Frankivsk Regional Clinical Skin and Venereal Dispensary"

Ivano-Frankivsk, Ukraine

Location

Municipal Health Care Institution "Kharkiv City Clinical Dermatovenerologic Dispensary №5"

Kharkiv, Ukraine

Location

Municipal Institution "Rivne Regional Dermatology and Venerology Dispensary" of Rivne Regional Council

Rivne, Ukraine

Location

Municipal Institution "Zaporizhzhya Regional Dermatovenerology Clinical Dispensary" of Zaporizhzhya Regional Council

Zaporizhzhya, Ukraine

Location

Results Point of Contact

• Title: Chauvel Virginie
• Organization: Dermax

chauvelvirginie07@gmail.com

+32 488 07 04 18

Study Officials

• Evgeniy Cherepanov, MD

  bioRASI, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: May 22, 2018
• Study Start: April 20, 2018
• Primary Completion: December 2, 2018
• Study Completion: January 31, 2020
• Last Updated: July 27, 2021
• Results First Posted: July 27, 2021

Record last verified: 2019-02

Locations

US (4); UA (5); RU (8)