A Phase 3 interventional study of Imiquimod 5% cream and Placebo cream in Anogenital Human Papillomavirus Infection and Condyloma Anal, sponsored by Medical University Innsbruck. Status unknown at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-23.
Sponsored by Medical University Innsbruck · Phase 3, Interventional, and Treatment
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
116 studies on the registry are indexed under Condylomata Acuminata; 11 are open to participants now.
This study's planned enrollment of 200 is above the median of 158 across 95 interventional studies indexed under Condylomata Acuminata.
Browse Condylomata Acuminata studies →Medical University Innsbruck is the lead sponsor of 186 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Imiquimod 5% cream therapy Fulguration
Drug: Imiquimod 5% cream · Procedure: Fulguration
Placebo cream therapy Fulguration
Drug: Placebo cream · Procedure: Fulguration
Patients receive topical Imiquimod therapy for 12 weeks.
Also known as: Aldara
Patients receive topical Doritin therapy for 12 weeks
Also known as: Doritin
Surgical Excision and Fulguration of condyloma
Difference in recurrence rates between the two arms
Recurrence is evaluated by clinical examination (proctoscopy)
Time frame: 12 months
CD4 (cluster of differentiation 4) cell count
Influence of CD4 cell count in the subgroup of HIV positive patients
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2021; primary completion for Nov 2024, 36 months later.
Of 28 phase 3 interventional studies under Condylomata Acuminata, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 61. This study's planned 36 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Imiquimod
Medical University Innsbruck →