Genital WartsPhase 3NCT00674739
Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
A Phase 3 study testing Imiquimod and 3.75% imiquimod cream in people with Genital Warts, run by Graceway Pharmaceuticals, LLC at 30 sites in United States.
Trial summary
The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Genital Warts
- What is being tested?
- Imiquimod and 3.75% imiquimod cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 470 participants
- Where
- 30 sitesUnited States
- Study dates
- May 2008to Jul 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- In good general health
- Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 warts
- Negative pregnancy test (for women who are able to become pregnant)
Who cannot join
- Women who are pregnant, lactating or planning to become pregnant during the study
- Evidence of clinically significant or unstable disease (such as stroke, heart attack)
- Have any of the following conditions: HIV infection; current or history of high risk HPV infection (e.g., HPV 16, 18, etc.); outbreak of herpes genitalia in the wart areas; internal warts requiring or undergoing treatment; dermatological disease (e.g., psoriasis) or skin condition in the wart areas
- Have received specific treatments in the treatment area(s) within the designated time period prior to study treatment initiation.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Dermatology Practice
Ann Arbor, Michigan, 48103
Perimeter Institute for Clinical Research
Atlanta, Georgia, 30338
Medical College of Georgia
Augusta, Georgia, 30912
Professional Quality Research, Women Partners in Health
Austin, Texas, 78705
Professional Quality Research, The Urology Team
Austin, Texas, 78759
Visions Clinical Research
Boynton Beach, Florida, 33437
Clinicos, LLC
Colorado Springs, Colorado, 80904
University of Texas Southwestern Medical Center Dermatology Dept
Dallas, Texas, 75390
Colorado Medical Research Center
Denver, Colorado, 80210
Edinger Medical Group Clinical Research Center
Fountain Valley, California, 92708
East Bay Dermatology Medical Group
Fremont, California, 94538
Private Practice
Great Neck, New York, 11021
Indiana University Infectious Disease Research Group
Indianapolis, Indiana, 46202
WILMAX Clinical Research
Mobile, Alabama, 36608
Montgomery Women's Health Associates
Montgomery, Alabama, 36116
Segal Institute for Clinical Research
North Miami, Florida, 33161
Alegent Health Clinic
Omaha, Nebraska, 68124
Philadelphia Institute of Dermatology
Philadelphia, Pennsylvania, 19144
Women's Health Research
Phoenix, Arizona, 85015
Precision Trials
Phoenix, Arizona, 85032
Private Practice
Purchase, New York, 10577
Atlanta North Gynecology
Roswell, Georgia, 30075
Progressive Clinical Research
San Antonio, Texas, 78229
Coastal Medical Research Group
San Luis Obispo, California, 93405
Miami Research Associates
South Miami, Florida, 33143
State University of NY Stony Brook
Stony Brook, New York, 11794
Discovery Clinical Research
Sunrise, Florida, 33316
Premier Pharmaceutical Research
Tempe, Arizona, 85282
Torrance Clinical Research
Torrance, California, 90505
Visions Clinical Research
Tucson, Arizona, 85712
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts
The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams.
External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.
- Conditions
- Genital Warts
- Being tested
- Imiquimod, 3.75% imiquimod cream, placebo cream
- Keywords
- external genital warts, perianal warts, condylomata acuminata, venereal warts, HPV types 6 and 11
- 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
Also called imiquimod 2.5% topical creram
daily topical application for up to 8 weeks
3.75% imiquimod creamDrug
Also called 3.75% imiquimod topical cream
3.75% imiquimod cream applied daily to wart areas for up to 8 weeks.
placebo creamDrug
Also called placebo matching cream
placebo cream applied daily to wart areas for up to 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| imiquimod cream | Experimental | 2.5% imiquimod cream applied daily to wart area for up to 8 weeks Receives: Drug: Imiquimod |
| 3.75% imiquimod cream | Experimental | 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks. Receives: Drug: 3.75% imiquimod cream |
| placebo cream | Placebo comparator | placebo cream applied daily to wart areas for up to 8 weeks Receives: Drug: placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study
Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.
Measured: Up to 16 weeks
Secondary outcomes (2)
Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.
Local skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit.
Rest period was a temporary interruption of dosing dur to intolerable LSRs.
Measured: Up to 16 weeks
Treatment Related Adverse Events
Numbers of subjects in each treatment group reporting one or more adverse events
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Graceway Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jason Wu, MD, Study director, Graceway Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674739
- Sponsor's protocol ID
- GW01-0801
- Status last verified
- May 2011
- First submitted
- 7 May 2008
- Last updated
- 24 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts
- ClinicalTrials.gov ID
- NCT00674739
- Acronym / sponsor ID
- GW01-0801
- Conditions
- Genital Warts
- Keywords
- external genital warts, perianal warts, condylomata acuminata, venereal warts, HPV types 6 and 11
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Graceway Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Posted 18 May 2011
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 determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams.
External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| imiquimod cream | Experimental | Drug: Imiquimod2.5% imiquimod cream applied daily to wart area for up to 8 weeks |
| 3.75% imiquimod cream | Experimental | Drug: 3.75% imiquimod cream3.75% imiquimod cream applied daily to wart areas for up to 8 weeks. |
| placebo cream | Placebo comparator | Drug: placebo creamplacebo cream applied daily to wart areas for up to 8 weeks |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- In good general health
- Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 warts
- Negative pregnancy test (for women who are able to become pregnant)
Key exclusion criteria (4 listed)
- Women who are pregnant, lactating or planning to become pregnant during the study
- Evidence of clinically significant or unstable disease (such as stroke, heart attack)
- Have any of the following conditions: HIV infection; current or history of high risk HPV infection (e.g., HPV 16, 18, etc.); outbreak of herpes genitalia in the wart areas; internal warts requiring or undergoing treatment; dermatological disease (e.g., psoriasis) or skin condition in the wart areas
- Have received specific treatments in the treatment area(s) within the designated time period prior to study treatment initiation.
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 |
|---|---|---|
| ImiquimodAlso: imiquimod 2.5% topical creramdaily topical application for up to 8 weeks | Drug | imiquimod cream |
| 3.75% imiquimod creamAlso: 3.75% imiquimod topical cream3.75% imiquimod cream applied daily to wart areas for up to 8 weeks. | Drug | 3.75% imiquimod cream |
| placebo creamAlso: placebo matching creamplacebo cream applied daily to wart areas for up to 8 weeks | Drug | placebo cream |
Primary outcome
Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study
Time frame: Up to 16 weeks
Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.
2 secondary outcomes
Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.
Time frame: Up to 16 weeks
Treatment Related Adverse Events
Time frame: Up to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Genital Warts
Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
Not yet recruitingPhase 3
Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts
Warts, Plantar Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
Not yet recruitingEarly Phase 1
the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
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.
Jason Wu, MD study director
Graceway Pharmaceuticals
30 sites 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 and 3.75% imiquimod cream in people with Genital Warts, run by Graceway Pharmaceuticals, LLC at 30 sites in United States.
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 3 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: finished, as of the sponsor's last update on 24 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. 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?
Yes. Results are posted in the registry (first posted 18 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study (time frame: Up to 16 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 24 May 2011.