Comparison Between Podofilox Topical Gel 0.5% and Allerga... | NCT03532776

Status Module

Name	Class
bioRASI, LLC	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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 %

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:
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.
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.

Name	Affiliation	Role
Evgeniy Cherepanov, MD	bioRASI, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Leon Medical Research		Miami	Florida	33015	United States
Well Pharma Medical Research Corp

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Podofilox Gel 0.5 %	Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles Podofilox Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
FG001	Condylox Topical Gel 0.5%

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 15, 2018	Apr 22, 2021

Arm/Group Information

ID	Title	Description
BG000	Podofilox Gel 0.5 %	Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles Podofilox Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
BG001	Condylox Topical Gel 0.5%	Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles Condylox Topical Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
BG002	Placebo Gel	Subjects in this arm will receive a vehicle that matches the test product, except for the inclusion of the active ingredient Placebo Gel: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG000201 BG001198 BG00267 BG003466

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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".

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.

Posted

Count of Participants

Participants

28 days.

ID	Title	Description
OG000	Podofilox Gel 0.5 %	Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles Podofilox Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
OG001	Condylox Topical Gel 0.5%	Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles Condylox Topical Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
OG002	Placebo Gel	Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles

Units	Counts
Participants	OG000155 OG001153 OG00252

Title

Denominators

Categories

Title	Measurements
	OG000100 OG001102 OG00212

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Equivalence ratio	0.98			2-Sided	90	-12	7					Equivalence	BE limits: -20.0% to 20.0%

Secondary

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).

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).

Posted

Count of Participants

Participants

28 days (at visit 6)

ID	Title	Description
OG000	Podofilox Gel 0.5 %	Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles Podofilox Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
OG001	Condylox Topical Gel 0.5%	Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles Condylox Topical Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles

Secondary

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.

Posted

Count of Participants

Participants

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.

ID	Title	Description
OG000	Podofilox Gel 0.5 %	Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles Podofilox Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
OG001	Condylox Topical Gel 0.5%	Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles Condylox Topical Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
OG002	Placebo Gel	Subjects in this arm will receive a vehicle that matches the test product, except for the inclusion of the active ingredient Placebo Gel: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Podofilox Gel 0.5 %	Podofilox Gel 0.5% twice a day, three days following by four days of discontinuation, up to four cycles Podofilox Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles	201	0	201	105	201
EG001	Condylox Topical Gel 0.5%	Condylox Topical Gel 0.5% twice daily, three days following by four days of discontinuation, up to four cycles Condylox Topical Gel 0.5%: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles	198	1	198	114	198
EG002	Placebo Gel	Subjects in this arm will receive a vehicle that matches the test product, except for the inclusion of the active ingredient Placebo Gel: Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles	67	0	67	33	67

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Application site erythema	General disorders	Non-systematic Assessment	EG00069 affected201 at risk EG00179 affected198 at risk EG00220 affected67 at risk
Application site pain	General disorders	Non-systematic Assessment	EG00052 affected201 at risk EG00156 affected198 at risk EG00216 affected67 at risk
Application site pruritus	General disorders	Non-systematic Assessment	EG00024 affected201 at risk EG00126 affected198 at risk EG0027 affected67 at risk
Application site dryness	General disorders	Non-systematic Assessment	EG00019 affected201 at risk EG00117 affected198 at risk EG0024 affected67 at risk
Application site erosion	General disorders	Non-systematic Assessment	EG00015 affected201 at risk EG00119 affected198 at risk EG0021 affected67 at risk
Application site erosion	General disorders	Non-systematic Assessment	EG0006 affected201 at risk EG00110 affected198 at risk EG0025 affected67 at risk
Application site haemorrhage	General disorders	Non-systematic Assessment	EG0002 affected201 at risk EG0012 affected198 at risk EG0020 affected67 at risk
Application site necrosis	General disorders	Non-systematic Assessment	EG0000 affected201 at risk EG0011 affected198 at risk EG0020 affected67 at risk
Feeling hot	General disorders	Non-systematic Assessment	EG0001 affected201 at risk EG0010 affected198 at risk EG0020 affected67 at risk
Erythema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0004 affected201 at risk EG0014 affected198 at risk EG0021 affected67 at risk
Pruritus	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0003 affected201 at risk EG0013 affected198 at risk EG0022 affected67 at risk
Skin burning sensation	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected201 at risk EG0012 affected198 at risk EG0020 affected67 at risk
Dry skin	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected201 at risk EG0011 affected198 at risk EG0020 affected67 at risk
Pain of skin	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected201 at risk EG0011 affected198 at risk EG0020 affected67 at risk
Skin erosion	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected201 at risk EG0011 affected198 at risk EG0020 affected67 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG0003 affected201 at risk EG0013 affected198 at risk EG0022 affected67 at risk
Paraesthesia	Nervous system disorders	Non-systematic Assessment	EG0001 affected201 at risk EG0011 affected198 at risk EG0021 affected67 at risk
Burning sensation	Nervous system disorders	Non-systematic Assessment	EG0000 affected201 at risk EG0011 affected198 at risk EG0020 affected67 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0000 affected201 at risk EG0011 affected198 at risk EG0020 affected67 at risk
Abdominal pain lower	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected201 at risk EG0010 affected198 at risk EG0020 affected67 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected201 at risk EG0011 affected198 at risk EG0020 affected67 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected201 at risk EG0010 affected198 at risk EG0020 affected67 at risk
Genital herpes	Infections and infestations	Non-systematic Assessment	EG0001 affected201 at risk EG0010 affected198 at risk EG0020 affected67 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0000 affected201 at risk EG0011 affected198 at risk EG0020 affected67 at risk
Dysuria	Renal and urinary disorders	Non-systematic Assessment	EG0002 affected201 at risk EG0010 affected198 at risk EG0020 affected67 at risk
Thermal burn	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected201 at risk EG0011 affected198 at risk EG0020 affected67 at risk
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected201 at risk EG0011 affected198 at risk EG0020 affected67 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected201 at risk EG0010 affected198 at risk EG0020 affected67 at risk
Vulvovaginal burning sensation	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected201 at risk EG0011 affected198 at risk EG0020 affected67 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected201 at risk EG0010 affected198 at risk EG0020 affected67 at risk
Hyperaemia	Vascular disorders	Non-systematic Assessment	EG0001 affected201 at risk EG0010 affected198 at risk EG0020 affected67 at risk