Anogenital Human Papillomavirus InfectionPhase 3AdAMNCT03289260
Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial
A Phase 3 study testing Imiquimod 5% cream and Fulguration in people with Anogenital Human Papillomavirus Infection and Condyloma Anal, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anogenital Human Papillomavirus Infection, Condyloma Anal
- What is being tested?
- Imiquimod 5% cream and Fulguration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 15 Nov 2021to 15 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Austria1 site
Visceral-, Transplant- and Thoracic Surgery
Innsbruck, Tyrol, 6020
About this study
Official title: Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions
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
- Being tested
- Imiquimod 5% cream, Placebo cream, Fulguration
- Keywords
- Condylomata acuminata, Fulguration, Imiquimod
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod 5% creamDrug
Also called Aldara
Patients receive topical Imiquimod therapy for 12 weeks.
Placebo creamDrug
Also called Doritin
Patients receive topical Doritin therapy for 12 weeks
FulgurationProcedure or surgery
Surgical Excision and Fulguration of condyloma
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Imiquimod 5% cream therapy Fulguration Receives: Drug: Imiquimod 5% cream; Procedure: Fulguration |
| Placebo Arm | Placebo comparator | Placebo cream therapy Fulguration Receives: Drug: Placebo cream; Procedure: Fulguration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in recurrence rates between the two arms
Recurrence is evaluated by clinical examination (proctoscopy)
Measured: 12 months
Secondary outcomes (1)
CD4 (cluster of differentiation 4) cell count
Influence of CD4 cell count in the subgroup of HIV positive patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start15 Nov 2021 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anogenital Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irmgard E Kronberger, MD, Medical University Innsbruck
- Investigators
- Dietmar Öfner-Velano, MD, Study director, University Hospital for Visceral, Transplant and Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289260
- Sponsor's protocol ID
- AdAM_2017
- Acronym
- AdAM
- Status last verified
- Sep 2020
- First submitted
- 19 Sep 2017
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions
- ClinicalTrials.gov ID
- NCT03289260
- Acronym / sponsor ID
- AdAM / AdAM_2017
- Keywords
- Condylomata acuminata, Fulguration, Imiquimod
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 15 Nov 2021 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Drug: Imiquimod 5% cream, Procedure: FulgurationImiquimod 5% cream therapy Fulguration |
| Placebo Arm | Placebo comparator | Drug: Placebo cream, Procedure: FulgurationPlacebo cream therapy Fulguration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imiquimod 5% creamAlso: AldaraPatients receive topical Imiquimod therapy for 12 weeks. | Drug | Interventional Arm |
| Placebo creamAlso: DoritinPatients receive topical Doritin therapy for 12 weeks | Drug | Placebo Arm |
| FulgurationSurgical Excision and Fulguration of condyloma | Procedure or surgery | Interventional Arm, Placebo Arm |
Primary outcome
Difference in recurrence rates between the two arms
Time frame: 12 months
Recurrence is evaluated by clinical examination (proctoscopy)
1 secondary outcome
CD4 (cluster of differentiation 4) cell count
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dietmar Öfner-Velano, MD study director
University Hospital for Visceral, Transplant and Thoracic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imiquimod 5% cream and Fulguration in people with Anogenital Human Papillomavirus Infection and Condyloma Anal, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irmgard E Kronberger, MD (0043512504 ext. 80823, irmgard.kronberger@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in recurrence rates between the two arms (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.