Imiquimod therapy after surgical removal of anal HPV-lesions to reduce likelihood of recurrence

Adjuvante Imiquimod Therapie zur Senkung der Rezidivrate nach operativer Therapie bei analen HPV-Läsionen - AdAM

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000842-23-AT

Enrollment

200

Registered

2018-01-11

Start date

2018-02-19

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anal HPV-lesions

Interventions

Trade Name: Aldara Product Name: Aldara Pharmaceutical Form: Cream INN or Proposed INN: IMIQUIMOD CAS Number: 99011-02-6 Other descriptive name: Aldara Concentration unit: % percent Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age >=18 years - Indication of surgical sanitation of HPV-lesions in anal area by means of fulguration Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: - participation in other trials - diagnosis of HPV-associated lesions in the last 12 month - known allergy to Imiquimod - pregnant of lactating women

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective of the study to evaluate the efficacy of combination therapy of surgical intervention and "adjuvant" topical Imiquimod therapy;Secondary Objective: -Secondary aim of the trial is to evaluate the influence of the CD4 count on therapeutic effect of HIV-positive patients -Influence of the grading (high/low) on the regression rate -Additional effect on the perception of Adverse Events -Differences in subgroups (sex, HIV, MSM);Primary end point(s): Primary endpoint ist the difference in regression rate between intervention and placebo group within 12 month after fulguration;Timepoint(s) of evaluation of this end point: Follow-ups will be performed every 3 month during 1 year.	—

Measure

Time frame

Main Objective: Primary objective of the study to evaluate the efficacy of combination therapy of surgical intervention and "adjuvant" topical Imiquimod therapy;Secondary Objective: -Secondary aim of the trial is to evaluate the influence of the CD4 count on therapeutic effect of HIV-positive patients -Influence of the grading (high/low) on the regression rate -Additional effect on the perception of Adverse Events -Differences in subgroups (sex, HIV, MSM);Primary end point(s): Primary endpoint ist the difference in regression rate between intervention and placebo group within 12 month after fulguration;Timepoint(s) of evaluation of this end point: Follow-ups will be performed every 3 month during 1 year.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are: - CD4 count - number of regressions - differences in classification of the virus high/low risk - Subtyp analysis (Sex, HIV, MSM);Timepoint(s) of evaluation of this end point: Follow-ups will be performed every 3 month during 1 year.	—

Countries

Austria

Contacts

Public ContactDr. med. Sascha Czipin

Medical University Innsbruck

sascha.czipin@i-med.ac.at++4351250480823

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026