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Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts

Primary Purpose

Anogenital Warts, Condylomata Acuminata, Human Papillomavirus Infection

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AP611074

Placebo

About this trial

This is an interventional treatment trial for Anogenital Warts focused on measuring Genital warts, Anogenital warts, HPV, Human papillomavirus, Antiviral

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

Male or female patient aged between 18 and 55 years.
External condylomas, 1-15 lesions, non-confluent and individually isolated.
Lesions must not be internal (ie, they must not penetrate the urethral meatus, vagina or anal canal); their visualization must be complete by patients and investigators without major facilitation maneuvers and easily documented by digital pictures.
Lesions should have a total surface smaller than 5 cm2, and an individual surface smaller than 1 cm2; lesions should be easily measured using a "French Catheter Scale".
Lesions to be treated should have appeared between 1-6 months before screening and patients should not have received any previous condyloma treatment since their appearance.
For patients having previous episodes of condyloma lesions, they shouldn't have received any condyloma treatment for at least 12 months before screening.

Main Exclusion Criteria:

Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease that, in the Investigator's judgment, prevents the patients from participating to the study.
Patients with VIN or PIN (intraepithelial neoplasia of vulva or penis; ie, Bowenoid papulosis), or genital disease (ie, lichen sclerosus, lichen planus, lichen simplex chronicus, dermatitis, psoriasis, bullous diseases, systemic diseases with genital manifestations) requiring treatment.
Patients with fibroepithelial polyps or scaly non-viral papillomas, seborrheic keratosis, follicular papules, syringoma, or circumscribed lymphangiomas.
Patients whose skin condition or coloration would interfere with the observation and the follow-up of the lesions during the study.
Patients for whom a proper follow-up of the lesions during the study will not be possible, because of hair growth in the treatment area.

Sites / Locations

IADT - Instituto Argentino de Diagnostico y Tratamiento S.A.
Hospotal Italinao de Buenos Aires - Dept of Dermatology and Gynecology
Hopital Henri Mondor-Dept of Dermatology
SGS Aster

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AP611074 5% gel

Placebo gel

Arm Description

Twice daily application of 100 mg dose of AP611074 5% gel for 41 days followed by a single morning application on Day 42

Twice daily application of 100 mg dose of placebo gel for 41 days followed by a single morning application on Day 42

Outcomes

Primary Outcome Measures

Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment

Secondary Outcome Measures

Safety and local tolerability

Descriptive statistics will be calculated by comparing the number of subjects between Day 1 and Day 42 in each treatment group (active or placebo) presenting AEs, or changes in physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory parameters (biochemistry, hematology, urinalysis), and local tolerability (erythema, scaling, stinging, oedema)

Pharmacokinetic evaluation

Plasma concentrations of AP611074 will be measured from blood samples once weekly up to 8 weeks in all patients. Data will be summarized with descriptive statistics by nominal sampling time.

Full Information

NCT ID

NCT01532102

First Posted

January 12, 2012

Last Updated

May 29, 2018

Sponsor

Anaconda Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01532102

Brief Title

Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts

Official Title

A Double-blind, Placebo Controlled, Randomized, Phase IIa Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of Repeated Topical Applications Over 42 Days of AP611074 5% Gel in Condyloma Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

February 28, 2012 (Actual)

Primary Completion Date

May 6, 2013 (Actual)

Study Completion Date

May 6, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anaconda Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the safety, tolerability and efficacy of the topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human papillomavirus (HPV).

Detailed Description

Genital warts (GW; also called condylomas or condylomata acuminata) are lesions caused by infection of Human papillomavirus (HPV)(specifically HPV-6 or HPV-11 types, found in > 95% of lesions). GW are sexually transmitted and affect about 1% of the sexually active population. GW represent a distressful condition for social and sexual life, especially in the cases of external condylomas. No HPV-specific antiviral treatment exists to date, and all existing therapies (either surgical or drug) have limited efficacy, with a significant level of GW recurrences and are associated with local skin reactions. AP611074 is a synthetic new chemical entity that is a potent and selective inhibitor of the interaction between two viral proteins from HPV6 and HPV11, an interaction that is a necessary step for HPV DNA replication and thus viral production. AP611074 is the "first in class" specific HPV antiviral described to treat condyloma caused by HPV infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anogenital Warts, Condylomata Acuminata, Human Papillomavirus Infection

Keywords

Genital warts, Anogenital warts, HPV, Human papillomavirus, Antiviral

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AP611074 5% gel

Arm Type

Experimental

Arm Description

Twice daily application of 100 mg dose of AP611074 5% gel for 41 days followed by a single morning application on Day 42

Arm Title

Placebo gel

Arm Type

Placebo Comparator

Arm Description

Twice daily application of 100 mg dose of placebo gel for 41 days followed by a single morning application on Day 42

Intervention Type

Drug

Intervention Name(s)

AP611074

Other Intervention Name(s)

HPV antiviral, Anticondyloma drug

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo gel manufactured to appear identical to AP611074 5% gel

Primary Outcome Measure Information:

Title

Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Safety and local tolerability

Description

Time Frame

Up to 8 weeks

Title

Pharmacokinetic evaluation

Description

Plasma concentrations of AP611074 will be measured from blood samples once weekly up to 8 weeks in all patients. Data will be summarized with descriptive statistics by nominal sampling time.

Time Frame

Up to 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria: Male or female patient aged between 18 and 55 years. External condylomas, 1-15 lesions, non-confluent and individually isolated. Lesions must not be internal (ie, they must not penetrate the urethral meatus, vagina or anal canal); their visualization must be complete by patients and investigators without major facilitation maneuvers and easily documented by digital pictures. Lesions should have a total surface smaller than 5 cm2, and an individual surface smaller than 1 cm2; lesions should be easily measured using a "French Catheter Scale". Lesions to be treated should have appeared between 1-6 months before screening and patients should not have received any previous condyloma treatment since their appearance. For patients having previous episodes of condyloma lesions, they shouldn't have received any condyloma treatment for at least 12 months before screening. Main Exclusion Criteria: Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease that, in the Investigator's judgment, prevents the patients from participating to the study. Patients with VIN or PIN (intraepithelial neoplasia of vulva or penis; ie, Bowenoid papulosis), or genital disease (ie, lichen sclerosus, lichen planus, lichen simplex chronicus, dermatitis, psoriasis, bullous diseases, systemic diseases with genital manifestations) requiring treatment. Patients with fibroepithelial polyps or scaly non-viral papillomas, seborrheic keratosis, follicular papules, syringoma, or circumscribed lymphangiomas. Patients whose skin condition or coloration would interfere with the observation and the follow-up of the lesions during the study. Patients for whom a proper follow-up of the lesions during the study will not be possible, because of hair growth in the treatment area.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olivier Chosidow, MD, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

IADT - Instituto Argentino de Diagnostico y Tratamiento S.A.

City

Buenos Aires

ZIP/Postal Code

C1122AAL

Country

Argentina

Facility Name

Hospotal Italinao de Buenos Aires - Dept of Dermatology and Gynecology

City

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Hopital Henri Mondor-Dept of Dermatology

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

SGS Aster

City

Paris

ZIP/Postal Code

75014

Country

France

12. IPD Sharing Statement

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Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts

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