External Anogenital WartsPhase 3NCT03532776

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

A Phase 3 study testing Podofilox Gel 0.5% and Condylox Topical Gel 0.5% in people with External Anogenital Warts, run by Dermax SA at 17 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: External Anogenital Warts
What is being tested?: Podofilox Gel 0.5% and Condylox Topical Gel 0.5%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 466 participants
Where: 17 sitesin 3 countries
Study dates: 20 Apr 2018to 31 Jan 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

17 sites in 3 countries.

Country

City, postcode or hospital

17 sites in 3 countries

Russia8 sites

"Ecology of Health" LLC
Chelyabinsk
State Budgetary Institution of Healthcare "Chelyabinsk Regional Clinical Dermatovenerology Dispensary"
Chelyabinsk
State autonoumous institution of Healthcare of Moscow region "Korolev Dermatovenerology dispensary"
Korolyov
"Moscow scientific-practical center of Dermatovenerology and cosmetology"
Moscow
"Clinic of urology №1" LLC
Penza
Rostov State Medical University
Rostov-on-Don
State Budgetary Institution of Healthcare "Dermatovenerologic dispensary #8" of Krasnogvardeyskiy district of Saint Petersburg
Saint Petersburg
Regional State-Financed Health Institution of Healthcare "Smolensk Dermatovenerologic dispensary"
Smolensk

Other trials in Russia

Ukraine5 sites

Medical Center of Private Enterprise "Dzerkalo"
Dnipro
Municipal institution "Ivano-Frankivsk Regional Clinical Skin and Venereal Dispensary"
Ivano-Frankivsk
Municipal Health Care Institution "Kharkiv City Clinical Dermatovenerologic Dispensary №5"
Kharkiv
Municipal Institution "Rivne Regional Dermatology and Venerology Dispensary" of Rivne Regional Council
Rivne
Municipal Institution "Zaporizhzhya Regional Dermatovenerology Clinical Dispensary" of Zaporizhzhya Regional Council
Zaporizhzhya

Other trials in Ukraine

United States4 sites

TMC Life Research, Inc
Houston, Texas, 77054
Leon Medical Research
Miami, Florida, 33015
Well Pharma Medical Research Corp
Miami, Florida, 33143
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

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.

Read the 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.

Conditions: External Anogenital Warts
Being tested: Podofilox Gel 0.5%, Condylox Topical Gel 0.5%, Placebo Gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Podofilox 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%Drug
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
Placebo GelDrug
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles

Study groups in NCT03532776
Study group	Role	What they receive
Podofilox Gel 0.5 %	Experimental	Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles Receives: 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 Receives: 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 Receives: Drug: Placebo Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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".
Measured: 28 days.

Secondary outcomes (2)

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).
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 201831 Jan 2020

First posted22 May 2018
Study start20 Apr 2018
Primary completion2 Dec 2018
Study completion31 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for External Anogenital WartsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 466 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03532776
Sponsor's protocol ID: 016-POD-001
Status last verified: Feb 2019
First submitted: 11 Jan 2018
Last updated: 27 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03532776
Acronym / sponsor ID: 016-POD-001
Conditions: External Anogenital Warts
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 466 participants (actual)
Lead sponsor: Dermax SAIndustry (pharma, biotech, devices)
Collaborators: bioRASI, LLC
Study start: 20 Apr 2018 (actual)
Primary completion: 2 Dec 2018 (actual)
Study completion: 31 Jan 2020 (actual)
First posted: 22 May 2018 (actual)
Results: Posted 27 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Podofilox Gel 0.5 %	Experimental	Drug: Podofilox Gel 0.5%Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles
Condylox Topical Gel 0.5%	Active comparator	Drug: Condylox Topical Gel 0.5%Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles
Placebo Gel	Placebo comparator	Drug: Placebo GelSubjects in this arm will receive a vehicle that matches the test product, except for the inclusion of the active ingredient

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (16 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Podofilox Gel 0.5%Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles	Drug	Podofilox Gel 0.5 %
Condylox Topical Gel 0.5%Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles	Drug	Condylox Topical Gel 0.5%
Placebo GelApply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles	Drug	Placebo Gel

Primary outcome

Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas.
Time frame: 28 days.
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".

2 secondary outcomes

Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale.
Time frame: 28 days (at visit 6)
Analysis of Safety Variables Will be Based on All Adverse Events (AE).
Time frame: 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.

Results and safety

Results posted to the registry on 27 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Podofilox Gel 0.5 %	201	196
Condylox Topical Gel 0.5%	198	194
Placebo Gel	67	63

Primary outcome: Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas.

Time frame: 28 days.. Count of participants. Unit: Participants

Measure	Podofilox Gel 0.5 % n = 155	Condylox Topical Gel 0.5% n = 153	Placebo Gel n = 52
Value	100	102	12

Podofilox Gel 0.5 % vs Condylox Topical Gel 0.5%: Equivalence ratio: 0.98 (90% CI -12 to 7)

Population analysed: Due to GCP non-compliance in site 201, two sets of Efficacy Analysis were generated: Definitive Efficacy Analysis Set excluding site 201 and Supplemental Efficacy Analysis Set including site 201. Analysis using Definitive Efficacy Analysis Set (without site 201) were considered definitive for bioequivalence. The same analyses were performed using supplemental efficacy analysis set (sensitivity analysis) and these analyses were considered supportive.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Podofilox Gel 0.5 %	0 of 201 (0%)	105 of 201 (52.2%)	0 of 201
Condylox Topical Gel 0.5%	1 of 198 (0.5%)	114 of 198 (57.6%)	0 of 198
Placebo Gel	0 of 67 (0%)	33 of 67 (49.3%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Evgeniy Cherepanov, MD study director

bioRASI, LLC

17 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Podofilox Gel 0.5% and Condylox Topical Gel 0.5% in people with External Anogenital Warts, run by Dermax SA at 17 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Russia, Ukraine, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas. (time frame: 28 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03532776.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.