Trial · NCT03532776
Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts
NCT03532776, Phase 3, Completed, Dermax SA; results first posted 2021-07-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts. Trials, record NCT03532776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03532776
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts
- NCT number
- NCT03532776
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 466 participants, actual
- Lead sponsor
- Dermax SA
- Conditions
- External Anogenital Warts
- Interventions
- Podofilox Gel 0.5%, Condylox Topical Gel 0.5%, Placebo Gel
- First posted
- 2018-05-22
- Last updated
- 2021-07-27
- Results first posted
- 2021-07-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas. | 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". |
| Secondary | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | 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). |
| Secondary | 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. | AEs will be summarized based on the frequency of AEs and their severity for all treated subjects. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas. | 28 days. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | 28 days (at visit 6) | Safety Population, 266 subjects completed the study at visit 6 (Podofilox Gel 0.5%: 114 subjects; Condylox Topical Gel 0.5%: 102 subjects and Placebo gel: 50 subjects). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas. | Podofilox Gel 0.5 % | 100 | Participants | ||
| Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas. | Condylox Topical Gel 0.5% | 102 | Participants | ||
| Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas. | Placebo Gel | 12 | Participants | ||
| Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Podofilox Gel 0.5 % | Erythema / Absent | 102 | Participants | |
| Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Condylox Topical Gel 0.5% | Erythema / Absent | 81 | Participants | |
| Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Placebo Gel | Erythema / Absent | 45 | Participants | |
| Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Podofilox Gel 0.5 % | Erythema / Mild | 9 | Participants | |
| Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Condylox Topical Gel 0.5% | Erythema / Mild | 14 | Participants | |
| Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Placebo Gel | Erythema / Mild | 4 | Participants | |
| Local Application Site Reaction Scores (Erythema, Dryness, Burning/Stinging, Erosion, Edema, Pain, Itching, and Bleeding) Per Skin Reaction Scale. | Podofilox Gel 0.5 % | Erythema / Moderate | 3 | Participants |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Podofilox Gel 0.5 % | 201 | |
| Overall Study | STARTED | Condylox Topical Gel 0.5% | 198 | |
| Overall Study | STARTED | Placebo Gel | 67 | |
| Overall Study | COMPLETED | Podofilox Gel 0.5 % | 196 | |
| Overall Study | COMPLETED | Condylox Topical Gel 0.5% | 194 | |
| Overall Study | COMPLETED | Placebo Gel | 63 | |
| Overall Study | NOT COMPLETED | Podofilox Gel 0.5 % | 5 | |
| Overall Study | NOT COMPLETED | Condylox Topical Gel 0.5% | 4 | |
| Overall Study | NOT COMPLETED | Placebo Gel | 4 |
Source ClinicalTrials.gov
Adverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Application site erythema | General disorders | Podofilox Gel 0.5 % | 69 | 201 | |
| other | Application site erythema | General disorders | Condylox Topical Gel 0.5% | 79 | 198 | |
| other | Application site erythema | General disorders | Placebo Gel | 20 | 67 | |
| other | Application site pain | General disorders | Podofilox Gel 0.5 % | 52 | 201 | |
| other | Application site pain | General disorders | Condylox Topical Gel 0.5% | 56 | 198 | |
| other | Application site pain | General disorders | Placebo Gel | 16 | 67 | |
| other | Application site pruritus | General disorders | Podofilox Gel 0.5 % | 24 | 201 | |
| other | Application site pruritus | General disorders | Condylox Topical Gel 0.5% | 26 | 198 | |
| other | Application site pruritus | General disorders | Placebo Gel | 7 | 67 | |
| other | Application site dryness | General disorders | Podofilox Gel 0.5 % | 19 | 201 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Podofilox Gel 0.5 % | 0 | 201 |
| Total, all-cause mortality | Condylox Topical Gel 0.5% | 0 | 198 |
| Total, all-cause mortality | Placebo Gel | 0 | 67 |
| Total, other adverse events | Podofilox Gel 0.5 % | 105 | 201 |
| Total, other adverse events | Condylox Topical Gel 0.5% | 114 | 198 |
| Total, other adverse events | Placebo Gel | 33 | 67 |
| Total, serious adverse events | Podofilox Gel 0.5 % | 0 | 201 |
| Total, serious adverse events | Condylox Topical Gel 0.5% | 1 | 198 |
| Total, serious adverse events | Placebo Gel | 0 | 67 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03532776
GET https://conductscience.org/api/trials/v1/NCT03532776/results?page=2