Genital WartsPhase 4NCT00189293
Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts
A Phase 4 study testing Imiquimod in people with Genital Warts, run by MEDA Pharma GmbH & Co. KG at 12 sites in Italy.
Trial summary
The purpose of this study is to compare the recurrence rate following total clearance of external genital warts (EGWs) when clearance has been obtained by imiquimod (3 applications per week for 4 weeks) followed by ablative therapy (laser or electrocautery therapy) with that from just ablative therapy treatment alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genital Warts
- What is being tested?
- Imiquimod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 12 sitesItaly
- Study dates
- Jun 2005to Dec 2007
- Phase
- Phase 4
- 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
- Subjects with at least 1 visible genital or perianal wart
- Total wart area 1 to 40 square centimeters.
Who cannot join
- Pregnant or lactating women
- Known other sexually transmitted disease
- Evidence of a clinically significant immunodeficiency
- Evidence of unstable cardiovascular, pulmonary, hematological, hepatic, renal, endocrine, collagen vascular, neurological or gastrointestinal abnormality or disease.
- Treatment within the 4 weeks prior to the Randomization Visit with any of the following systemic or topical treatments: interferons, interferon inducers, immunomodulators, immunosuppressive drugs, antiviral drugs (except for systemic acyclovir, valacyclovir and famciclovir), cytotoxic drugs, investigational drugs, or any drugs known to have major organ toxicity.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
Clinica Ostetrica e Ginecologica Università Politecnica delle Marche
Ancona, 60123
Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia
Asti, 14100
Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico
Bari, 70100
Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele
Catania, 95124
Clinica Ostetrica Ginecologica, Ospedale Careggi
Florence, 50134
Struttura Complessa Oncologia Chirurgica C Istituto Scientifico dei Tumori IST
Genova, 16132
Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento
Milan, 20122
Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco
Milan
Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia
Modena, 41100
Unità Operativa di Ginecologia Oncologica, Ospedale Oncologico M. Ascoli
Palermo, 90127
Ostetricia e Ginecologia, Ospedale S. Maria delle Grazie
Pozzuoli, 80078
Ambulatorio di Colposcopia e Patologia Cervico-Vaginale, Università Cattolica del Sacro Cuore
Roma, 00168
About this study
Official title: Multicenter, Randomised, Double-blind, Vehicle-controlled Study Comparing Recurrence Rate Following Imiquimod 5% Cream or Vehicle 3 Times Per Week for 4 Weeks Prior to Ablative Therapy in Subjects Suffering From External Ano-Genital Warts
The purpose of this study is to compare the recurrence rate following total clearance of external genital warts (EGWs) when clearance has been obtained by imiquimod (3 applications per week for 4 weeks) followed by ablative therapy (laser or electrocautery therapy) with that from just ablative therapy treatment alone.
Read the detailed description
To compare the recurrence rate 24 weeks after ablative therapy in subjects with external genital warts trated with imiquimod, 3 applications per week for 4 weeks followed by ablative therapy versus vehicle, 3 applications per week for 4 weeks followed by ablative therapy. A recurrence is defined as the investoigator-assessed occurrence of lesion(s) within the baseline area cleared by the treatment: imiquimod/vehicle then ablative therapy (either the initial ablative therápy session (A0), or if required for complete clearance of baseline lesions, a second ablative therapy session (A2).
- Conditions
- Genital Warts
- Being tested
- Imiquimod, vehicle cream
- Keywords
- External Ano-Genital Warts, Ablative Therapy, Aldara
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImiquimodDrug
Imiquimod 5% cream three times per week for 4 weeks (1 sachet)
1 or 2 sachet(s)
vehicle creamOther
vehicle cream three times per week for 4 weeks (1 sachet)
1 or 2 sachet(s)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Imiquimod 5% cream Receives: Drug: Imiquimod |
| 2 | Other | vehicle cream Receives: Other: vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
recuurence rate 24 weeks after ablative therapy
Measured: 24 weeks
Secondary outcomes (7)
Time to recurrence
Recurrence rate at 4 and 12 weeks post ablation
Measured: 4 and 12 weeks
Reduction of EGW area
Measured: 4 and 12 weeks
Healing and cosmetic outcome
Measured: 4, 12 and 24 weeks
Local and general tolerability
Percent of complete clearance after initial topical treatment
Measured: up to 6 weeks after initial topical treatment
Occurrence of new lesions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital WartsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Fausto Boselli, MD, Principal investigator, Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189293
- Sponsor's protocol ID
- 1526-IMIQ
- Other IDs
- 2004-004654-19, 2004
- Status last verified
- Sep 2008
- First submitted
- 12 Sep 2005
- Last updated
- 7 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomised, Double-blind, Vehicle-controlled Study Comparing Recurrence Rate Following Imiquimod 5% Cream or Vehicle 3 Times Per Week for 4 Weeks Prior to Ablative Therapy in Subjects Suffering From External Ano-Genital Warts
- ClinicalTrials.gov ID
- NCT00189293
- Acronym / sponsor ID
- 1526-IMIQ
- Conditions
- Genital Warts
- Keywords
- External Ano-Genital Warts, Ablative Therapy, Aldara
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- 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.
The purpose of this study is to compare the recurrence rate following total clearance of external genital warts (EGWs) when clearance has been obtained by imiquimod (3 applications per week for 4 weeks) followed by ablative therapy (laser or electrocautery therapy) with that from just ablative therapy treatment alone.
Detailed description
To compare the recurrence rate 24 weeks after ablative therapy in subjects with external genital warts trated with imiquimod, 3 applications per week for 4 weeks followed by ablative therapy versus vehicle, 3 applications per week for 4 weeks followed by ablative therapy. A recurrence is defined as the investoigator-assessed occurrence of lesion(s) within the baseline area cleared by the treatment: imiquimod/vehicle then ablative therapy (either the initial ablative therápy session (A0), or if required for complete clearance of baseline lesions, a second ablative therapy session (A2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ImiquimodImiquimod 5% cream |
| 2 | Other | Other: vehicle creamvehicle cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with at least 1 visible genital or perianal wart
- Total wart area 1 to 40 square centimeters.
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Known other sexually transmitted disease
- Evidence of a clinically significant immunodeficiency
- Evidence of unstable cardiovascular, pulmonary, hematological, hepatic, renal, endocrine, collagen vascular, neurological or gastrointestinal abnormality or disease.
- Treatment within the 4 weeks prior to the Randomization Visit with any of the following systemic or topical treatments: interferons, interferon inducers, immunomodulators, immunosuppressive drugs, antiviral drugs (except for systemic acyclovir, valacyclovir and famciclovir), cytotoxic drugs, investigational drugs, or any drugs known to have major organ toxicity.
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 |
|---|---|---|
| ImiquimodImiquimod 5% cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s) | Drug | 1 |
| vehicle creamvehicle cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s) | Other | 2 |
Primary outcome
recuurence rate 24 weeks after ablative therapy
Time frame: 24 weeks
7 secondary outcomes
Time to recurrence
Recurrence rate at 4 and 12 weeks post ablation
Time frame: 4 and 12 weeks
Reduction of EGW area
Time frame: 4 and 12 weeks
Healing and cosmetic outcome
Time frame: 4, 12 and 24 weeks
Local and general tolerability
Percent of complete clearance after initial topical treatment
Time frame: up to 6 weeks after initial topical treatment
Occurrence of new lesions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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Warts
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.
Fausto Boselli, MD principal investigator
Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imiquimod in people with Genital Warts, run by MEDA Pharma GmbH & Co. KG at 12 sites in Italy.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recuurence rate 24 weeks after ablative therapy (time frame: 24 weeks). 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 7 Feb 2022.