NCT03532776 is a Phase 3 clinical trial of Podofilox Gel 0.5% in External Anogenital Warts, sponsored by Dermax SA.

Who is sponsoring NCT03532776?

NCT03532776 is sponsored by Dermax SA.

What drugs are being tested in NCT03532776?

Interventions in NCT03532776: Podofilox Gel 0.5%, Condylox Topical Gel 0.5%, Placebo Gel.

What condition does NCT03532776 study?

NCT03532776 studies External Anogenital Warts.

Is NCT03532776 still recruiting?

NCT03532776 is currently completed. Last updated 27 July 2021.

Are results published for NCT03532776?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-07-27 · How we verify

NCT03532776

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 27 July 2021

What this trial tests

Phase 3 trial testing Podofilox Gel 0.5% in External Anogenital Warts in 466 participants. Completed in 31 January 2020.

Timeline

20 April 2018

Primary endpoint
2 December 2018

31 January 2020

Quick facts

Lead sponsor	Dermax SA
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	466
Start date	20 April 2018
Primary completion	2 December 2018
Estimated completion	31 January 2020
Sites	17 locations across Russia, United States, Ukraine

Drugs / interventions tested

Podofilox Gel 0.5% — full drug profile →
Condylox Topical Gel 0.5% — full drug profile →
Placebo Gel

Conditions studied

External Anogenital Warts — all drugs for External Anogenital Warts →

Sponsor

Dermax SA — full company profile →

Who can join

Adults 18 to 65, any sex, with External Anogenital Warts. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas. Primary · 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".

Group	Value	95% CI
Podofilox Gel 0.5 %	100
Condylox Topical Gel 0.5%	102
Placebo Gel	12

Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. Secondary · 28 days (at visit 6)

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).

Erythema

Group	Value	95% CI
Podofilox Gel 0.5 %	102
Condylox Topical Gel 0.5%	81
Placebo Gel	45
Podofilox Gel 0.5 %	9
Condylox Topical Gel 0.5%	14
Placebo Gel	4
Podofilox Gel 0.5 %	3
Condylox Topical Gel 0.5%	7
Placebo Gel	1
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0

Dryness

Group	Value	95% CI
Podofilox Gel 0.5 %	111
Condylox Topical Gel 0.5%	94
Placebo Gel	50
Podofilox Gel 0.5 %	3
Condylox Topical Gel 0.5%	7
Placebo Gel	0
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	1
Placebo Gel	0
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0

Burning/Stinging

Group	Value	95% CI
Podofilox Gel 0.5 %	108
Condylox Topical Gel 0.5%	92
Placebo Gel	48
Podofilox Gel 0.5 %	4
Condylox Topical Gel 0.5%	5
Placebo Gel	1
Podofilox Gel 0.5 %	2
Condylox Topical Gel 0.5%	5
Placebo Gel	1
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0

Erosion

Group	Value	95% CI
Podofilox Gel 0.5 %	111
Condylox Topical Gel 0.5%	97
Placebo Gel	50
Podofilox Gel 0.5 %	1
Condylox Topical Gel 0.5%	2
Placebo Gel	0
Podofilox Gel 0.5 %	2
Condylox Topical Gel 0.5%	3
Placebo Gel	0
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0

Edema

Group	Value	95% CI
Podofilox Gel 0.5 %	112
Condylox Topical Gel 0.5%	98
Placebo Gel	50
Podofilox Gel 0.5 %	2
Condylox Topical Gel 0.5%	4
Placebo Gel	0
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0

Pain

Group	Value	95% CI
Podofilox Gel 0.5 %	114
Condylox Topical Gel 0.5%	99
Placebo Gel	50
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	3
Placebo Gel	0
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0

Itching

Group	Value	95% CI
Podofilox Gel 0.5 %	111
Condylox Topical Gel 0.5%	94
Placebo Gel	49
Podofilox Gel 0.5 %	1
Condylox Topical Gel 0.5%	6
Placebo Gel	1
Podofilox Gel 0.5 %	2
Condylox Topical Gel 0.5%	2
Placebo Gel	0
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0

Bleeding

Group	Value	95% CI
Podofilox Gel 0.5 %	114
Condylox Topical Gel 0.5%	102
Placebo Gel	50
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0

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

AEs will be summarized based on the frequency of AEs and their severity for all treated subjects.

Number of subjects with at least One TEAE

Group	Value	95% CI
Podofilox Gel 0.5 %	105
Condylox Topical Gel 0.5%	114
Placebo Gel	33

Number of Subjects with at Least One Related TEAE

Group	Value	95% CI
Podofilox Gel 0.5 %	102
Condylox Topical Gel 0.5%	105
Placebo Gel	29

Number of Subjects with at Least One Severe TEAE

Group	Value	95% CI
Podofilox Gel 0.5 %	4
Condylox Topical Gel 0.5%	1
Placebo Gel	0

Number of Subjects with at Least One TEAE Leading to Discontinuation

Group	Value	95% CI
Podofilox Gel 0.5 %	1
Condylox Topical Gel 0.5%	1
Placebo Gel	0

Number of Subjects with at Least One TEAE Leading to Death

Group	Value	95% CI
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	0
Placebo Gel	0

Number of Subjects with at Least One TESAE

Group	Value	95% CI
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	1
Placebo Gel	0

Number of Subjects with at Least One Related TESAE

Group	Value	95% CI
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	1
Placebo Gel	0

Number of Subjects with at Least One Severe TESAE

Group	Value	95% CI
Podofilox Gel 0.5 %	0
Condylox Topical Gel 0.5%	1
Placebo Gel	0

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Podofilox Gel 0.5 %

Serious: 0/201 (0%)

Deaths: 0/201

Condylox Topical Gel 0.5%

Serious: 1/198 (1%)

Deaths: 0/198

Placebo Gel

Serious: 0/67 (0%)

Deaths: 0/67

Serious adverse events (1 terms)

Reaction	System	Podofilox Gel 0.5 %	Condylox Topical Gel 0.5%	Placebo Gel
Application Site Necrosis	General disorders	—	—	—

Other adverse events (31 terms — click to expand)

Reaction	System	Podofilox Gel 0.5 %	Condylox Topical Gel 0.5%	Placebo Gel
Application site erythema	General disorders	—	—	—
Application site pain	General disorders	—	—	—
Application site pruritus	General disorders	—	—	—
Application site dryness	General disorders	—	—	—
Application site erosion	General disorders	—	—	—
Application site erosion	General disorders	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Application site haemorrhage	General disorders	—	—	—
Skin burning sensation	Skin and subcutaneous tissue disorders	—	—	—
Dysuria	Renal and urinary disorders	—	—	—
Application site necrosis	General disorders	—	—	—
Feeling hot	General disorders	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—
Pain of skin	Skin and subcutaneous tissue disorders	—	—	—
Skin erosion	Skin and subcutaneous tissue disorders	—	—	—
Paraesthesia	Nervous system disorders	—	—	—
Burning sensation	Nervous system disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Genital herpes	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Thermal burn	Injury, poisoning and procedural complications	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Vulvovaginal burning sensation	Reproductive system and breast disorders	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Hyperaemia	Vascular disorders	—	—	—

Most-reported serious reactions: Application Site Necrosis.

Data from ClinicalTrials.gov NCT03532776 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03532776 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dermax SA
Last refreshed: 27 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03532776.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing