NCT01532102

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2012

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

February 28, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2013

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

January 12, 2012

Last Update Submit

May 29, 2018

Conditions

Anogenital WartsCondylomata AcuminataHuman Papillomavirus Infection

Keywords

Genital wartsAnogenital wartsHPVHuman papillomavirusAntiviral

Outcome Measures

Primary Outcomes (1)

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

    6 weeks

Secondary Outcomes (2)

  • Safety and local tolerability

    Up to 8 weeks

  • Pharmacokinetic evaluation

    Up to 8 weeks

Study Arms (2)

AP611074 5% gel

EXPERIMENTAL

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

Drug: AP611074

Placebo gel

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AP611074DRUG
Also known as: HPV antiviral, Anticondyloma drug
AP611074 5% gel
PlaceboDRUG

Placebo gel manufactured to appear identical to AP611074 5% gel

Placebo gel

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Buenos Aires, C1122AAL, Argentina

Location

Hospotal Italinao de Buenos Aires - Dept of Dermatology and Gynecology

Buenos Aires, C1181ACH, Argentina

Location

Hopital Henri Mondor-Dept of Dermatology

Créteil, 94010, France

Location

SGS Aster

Paris, 75014, France

Location

MeSH Terms

Conditions

Condylomata AcuminataPapillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsGenital DiseasesUrogenital DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Chosidow, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

February 14, 2012

Study Start

February 28, 2012

Primary Completion

May 6, 2013

Study Completion

May 6, 2013

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

FR(2)AR(2)