Trials Sponsors Conditions Drugs Pricing

Conditions

Anogenital Human Papillomavirus Infection Condyloma Anal

Keywords

Condylomata acuminata, Fulguration, Imiquimod

Outcome Measures

Primary Outcomes (1)

Difference in recurrence rates between the two arms
Recurrence is evaluated by clinical examination (proctoscopy)
12 months

Secondary Outcomes (1)

CD4 (cluster of differentiation 4) cell count
12 months

Study Arms (2)

Interventional Arm

EXPERIMENTAL

Imiquimod 5% cream therapy Fulguration

Drug: Imiquimod 5% creamProcedure: Fulguration

Placebo Arm

PLACEBO COMPARATOR

Placebo cream therapy Fulguration

Drug: Placebo creamProcedure: Fulguration

Interventions

Imiquimod 5% creamDrug

Patients receive topical Imiquimod therapy for 12 weeks.

Also known as: Aldara

Interventional Arm

Placebo creamDrug

Patients receive topical Doritin therapy for 12 weeks

Also known as: Doritin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ability to understand and willingness to sign and date a written consent document
Male and female patients \>= 18 years of age

Sponsors & Collaborators

Medical University Innsbruck
Otherlead

Study Sites (1)

Visceral-, Transplant- and Thoracic Surgery

Innsbruck, Tyrol, 6020, Austria

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

ImiquimodDiathermy

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsGenital Diseases

Study Officials

Dietmar Öfner-Velano, MD
University Hospital for Visceral, Transplant and Thoracic Surgery
STUDY DIRECTOR

Central Study Contacts

Irmgard E Kronberger, MD

CONTACT

0043512504 irmgard.kronberger@i-med.ac.at

Sascha Czipin, MD

CONTACT

0043512504

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Leading Consultent

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 20, 2017

Study Start

November 15, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Interventional Arm

Placebo Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Interventional Arm

Placebo Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations