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

Medical University Innsbruck

Status and phase: Not yet enrolling; Phase 3

Conditions: Condyloma Anal; Anogenital Human Papillomavirus Infection

Treatments: Drug: Placebo cream; Drug: Imiquimod 5% cream; Procedure: Fulguration

Study type: Interventional

Funder types: Other

Identifiers

NCT03289260

AdAM_2017

Details and patient eligibility

About

AdAM is a prospective, randomized, controlled, double-blinded, monocentric trial in patients receiving surgical therapy due to anal HPV infection.

Aim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical Imiquimod-therapy). It is planned to include 200 patients.

100 patients receive surgical therapy+ topical Imiquimod therapy, 100 patients receive surgical therapy + topical Placebo therapy

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to understand and willingness to sign and date a written consent document
• Male and female patients >= 18 years of age
• Negative urine/serum pregnancy test
• Indication for surgical therapy of anal HPV lesions

Exclusion criteria

• Participation in another clinical study with experimental therapy
• Diagnosis and therapy of HPV associated lesions in the last 12 months
• Known intolerance of hypersensitivity to Imiquimod
• Women who are pregnant of lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Interventional Arm

Experimental group

Description:

Imiquimod 5% cream therapy Fulguration

Treatment:

Drug: Imiquimod 5% cream

Procedure: Fulguration

Placebo Arm

Placebo Comparator group

Description:

Placebo cream therapy Fulguration

Treatment:

Drug: Placebo cream

Procedure: Fulguration