A Phase 3 interventional study of Podofilox Gel 0.5% and Condylox Topical Gel 0.5% in External Anogenital Warts, sponsored by Dermax SA. Completed at 17 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-27.
Sponsored by Dermax SA · Phase 3, Interventional, and Treatment
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study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations
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.
180 studies on the registry are indexed under Warts; 28 are open to participants now.
This study's enrollment of 466 is above the median of 70 across 159 interventional studies indexed under Warts.
Browse Warts studies →This is the only study on the registry with Dermax SA as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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% twice daily, three days following by four days of discontinuation, up to four cycles
Drug: Condylox Topical Gel 0.5%
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
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
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".
Time frame: 28 days.
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).
Time frame: 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.
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.
| Milestone | Podofilox Gel 0.5 % | Condylox Topical Gel 0.5% | Placebo Gel |
|---|---|---|---|
| Started | 201 | 198 | 67 |
| Completed | 196 | 194 | 63 |
| Not completed | 5 | 4 | 4 |
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".
| Participants | Podofilox Gel 0.5 % | Condylox Topical Gel 0.5% | Placebo Gel |
|---|---|---|---|
| Number and Percentage of Subjects With Total Disappearance of All Warts Within All Treated Areas. | 100 | 102 | 12 |
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).
| Participants | Podofilox Gel 0.5 % | Condylox Topical Gel 0.5% | Placebo Gel |
|---|---|---|---|
| Erythema — Absent | 102 | 81 | 45 |
| Erythema — Mild | 9 | 14 | 4 |
| Erythema — Moderate | 3 | 7 | 1 |
| Erythema — Severe | 0 | 0 | 0 |
| Dryness — Absent | 111 | 94 | 50 |
| Dryness — Mild | 3 | 7 | 0 |
| Dryness — Moderate | 0 | 1 | 0 |
| Dryness — Severe | 0 | 0 | 0 |
| Burning/Stinging — Absent | 108 | 92 | 48 |
| Burning/Stinging — Mild | 4 | 5 | 1 |
| Burning/Stinging — Moderate | 2 | 5 | 1 |
| Burning/Stinging — Severe | 0 | 0 | 0 |
| Erosion — Absent | 111 | 97 | 50 |
| Erosion — Mild | 1 | 2 | 0 |
| Erosion — Moderate | 2 | 3 | 0 |
| Erosion — Severe | 0 | 0 | 0 |
| Edema — Absent | 112 | 98 | 50 |
| Edema — Mild | 2 | 4 | 0 |
| Edema — Moderate | 0 | 0 | 0 |
| Edema — Severe | 0 | 0 | 0 |
| Pain — Absent | 114 | 99 | 50 |
| Pain — Mild | 0 | 3 | 0 |
| Pain — Moderate | 0 | 0 | 0 |
| Pain — Severe | 0 | 0 | 0 |
| Itching — Absent | 111 | 94 | 49 |
| Itching — Mild | 1 | 6 | 1 |
| Itching — Moderate | 2 | 2 | 0 |
| Itching — Severe | 0 | 0 | 0 |
| Bleeding — Absent | 114 | 102 | 50 |
| Bleeding — Mild | 0 | 0 | 0 |
| Bleeding — Moderate | 0 | 0 | 0 |
| Bleeding — Severe | 0 | 0 | 0 |
AEs will be summarized based on the frequency of AEs and their severity for all treated subjects.
| Participants | Podofilox Gel 0.5 % | Condylox Topical Gel 0.5% | Placebo Gel |
|---|---|---|---|
| Number of subjects with at least One TEAE | 105 | 114 | 33 |
| Number of Subjects with at Least One Related TEAE | 102 | 105 | 29 |
| Number of Subjects with at Least One Severe TEAE | 4 | 1 | 0 |
| Number of Subjects with at Least One TEAE Leading to Discontinuation | 1 | 1 | 0 |
| Number of Subjects with at Least One TEAE Leading to Death | 0 | 0 | 0 |
| Number of Subjects with at Least One TESAE | 0 | 1 | 0 |
| Number of Subjects with at Least One Related TESAE | 0 | 1 | 0 |
| Number of Subjects with at Least One Severe TESAE | 0 | 1 | 0 |
| Number of Subjects with at Least One TESAE Leading to Discontinuation | 0 | 1 | 0 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Podofilox Gel 0.5 % | 0/201 (0%) | 0/201 (0%) | 105/201 (52.2%) |
| Condylox Topical Gel 0.5% | 0/198 (0%) | 1/198 (0.5%) | 114/198 (57.6%) |
| Placebo Gel | 0/67 (0%) | 0/67 (0%) | 33/67 (49.3%) |
| Event | Podofilox Gel 0.5 % | Condylox Topical Gel 0.5% | Placebo Gel |
|---|---|---|---|
| Application Site NecrosisGeneral disorders | 0/201 | 1/198 | 0/67 |
| Event | Podofilox Gel 0.5 % | Condylox Topical Gel 0.5% | Placebo Gel |
|---|---|---|---|
| Application site erythemaGeneral disorders | 69/201 | 79/198 | 20/67 |
| Application site painGeneral disorders | 52/201 | 56/198 | 16/67 |
| Application site pruritusGeneral disorders | 24/201 | 26/198 | 7/67 |
| Application site erosionGeneral disorders | 15/201 | 19/198 | 1/67 |
| Application site drynessGeneral disorders | 19/201 | 17/198 | 4/67 |
| Application site erosionGeneral disorders | 6/201 | 10/198 | 5/67 |
| PruritusSkin and subcutaneous tissue disorders | 3/201 | 3/198 | 2/67 |
| HeadacheNervous system disorders | 3/201 | 3/198 | 2/67 |
| ErythemaSkin and subcutaneous tissue disorders | 4/201 | 4/198 | 1/67 |
| ParaesthesiaNervous system disorders | 1/201 | 1/198 | 1/67 |
| Age, Categorical(Participants) | Podofilox Gel 0.5 % | Condylox Topical Gel 0.5% | Placebo Gel | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 201 | 198 | 67 | 466 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Podofilox Gel 0.5 % | Condylox Topical Gel 0.5% | Placebo Gel | Total |
|---|---|---|---|---|
| Mean | 35.6 ± 12.745 | 37.7 ± 11.24 | 32.3 ± 10.401 | 34.7 ± 11.705 |
| Sex: Female, Male(Participants) | Podofilox Gel 0.5 % | Condylox Topical Gel 0.5% | Placebo Gel | Total |
|---|---|---|---|---|
| Female | 85 | 83 | 28 | 196 |
| Male | 116 | 115 | 39 | 270 |
| Ethnicity (NIH/OMB)(Participants) | Podofilox Gel 0.5 % | Condylox Topical Gel 0.5% | Placebo Gel | Total |
|---|---|---|---|---|
| Hispanic or Latino | 36 | 38 | 17 | 91 |
| Not Hispanic or Latino | 165 | 160 | 50 | 375 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Podofilox Gel 0.5 % | Condylox Topical Gel 0.5% | Placebo Gel | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 2 | 0 | 0 | 2 |
| Native Hawaiian or Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 19 | 14 | 5 | 38 |
| White | 176 | 180 | 62 | 418 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| other | 4 | 4 | 0 | 8 |
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