WartsPhase 2NCT00115141
Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults
A Phase 2 study testing Resiquimod in people with Warts, run by Graceway Pharmaceuticals, LLC.
Trial summary
The primary purpose of this study is to evaluate the effectiveness in adults, of four different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks. A second purpose is to evaluate the safety of the drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Warts
- What is being tested?
- Resiquimod
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to not given
- Phase
- Phase 2
- 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
- Diagnosis of common warts
- Two forms of birth control
Who cannot join
- Pregnant or breast feeding
- Other types of warts, ie. plantar
- Currently participating in another clinical study
- Chronic viral hepatitis B or C
About this study
Official title: A Three-Stage, Modified-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 3 Times Per Week for 4 Weeks for the Treatment of Common Warts in Adults
The primary purpose of this study is to evaluate the effectiveness in adults, of four different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks.
A second purpose is to evaluate the safety of the drug.
- Conditions
- Warts
- Being tested
- Resiquimod
- Keywords
- Wart(s), Adults, Common Wart(s)
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResiquimodDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of treated wart(s)
Secondary outcomes (2)
Partial clearance of treated wart(s)
Wart recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2005 (estimated)
- Study startApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 88 participants
Sponsor and investigators
- Lead sponsor
- Graceway Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115141
- Sponsor's protocol ID
- 1513-RESI
- Status last verified
- Nov 2006
- First submitted
- 21 Jun 2005
- Last updated
- 19 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Stage, Modified-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 3 Times Per Week for 4 Weeks for the Treatment of Common Warts in Adults
- ClinicalTrials.gov ID
- NCT00115141
- Acronym / sponsor ID
- 1513-RESI
- Conditions
- Warts
- Keywords
- Wart(s), Adults, Common Wart(s)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants
- Lead sponsor
- Graceway Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- First posted
- 22 Jun 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 primary purpose of this study is to evaluate the effectiveness in adults, of four different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks.
A second purpose is to evaluate the safety of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of common warts
- Two forms of birth control
Key exclusion criteria (4 listed)
- Pregnant or breast feeding
- Other types of warts, ie. plantar
- Currently participating in another clinical study
- Chronic viral hepatitis B or C
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 |
|---|---|---|
| Resiquimod | Drug | – |
Primary outcome
Clearance of treated wart(s)
2 secondary outcomes
Partial clearance of treated wart(s)
Wart recurrence
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 19 Feb 2007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resiquimod in people with Warts, run by Graceway Pharmaceuticals, LLC.
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 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 19 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Clearance of treated wart(s). 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 19 Feb 2007.