KeratosisPhase 4NCT00110682
Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses
A Phase 4 study testing Imiquimod used as an adjunct to cryotherapy in people with Keratosis and Actinic Keratosis, run by Derm Research @ 888 Inc. at 3 sites in Canada.
Trial summary
Study Aims: To compare the long-term efficacy and safety of imiquimod versus vehicle used as an adjunct to cryotherapy. To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratosis, Actinic Keratosis
- What is being tested?
- Imiquimod used as an adjunct to cryotherapy
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2005to Dec 2006
- 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
- Diagnosis of actinic keratosis with 4 or more discreet lesions on the face or balding scalp. Lesions must be within a treatment area not exceeding 50 cm2 (combined total must not exceed 50 cm2)
- Women of childbearing potential using appropriate contraceptive methods
Who cannot join
- Previous treatments with imiquimod for AK in the prescribed area within the past 5 months or cryosurgery in the same area within the past 4 weeks.
- Patients unwilling to stay out of the sun or wear protective clothing or to use sunscreen with a minimum of SPF 15 during the study.
- Basal or squamous cell carcinomas in the prescribed treatment area in the past 2 years.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Centre de Recherche Dermatologique, CRDQ
Sainte-Foy, Quebec, G1V 4X7
DermResearch @ 888 Inc
Vancouver, British Columbia, V4C 6X4
Windsor Clinical Research
Windsor, Ontario
About this study
Official title: A Randomized, Parallel-Group, Vehicle-Controlled, Double-Blind Study of Topical Imiquimod 5% Cream Used as an Adjunct to Cryotherapy in the Management of Actinic Keratoses, With a Long-Term (1 Year) Follow-Up
Study Aims:
- To compare the long-term efficacy and safety of imiquimod versus vehicle used as an adjunct to cryotherapy.
- To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups.
Hypothesis: The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses (AK) compared to the vehicle arm.
Read the detailed description
Evaluation of: (i) topical imiquimod 5% cream or (ii) vehicle cream used two times weekly for eight weeks starting two weeks post cryotherapy.
Study Aims:
- To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups.
- To assess and compare the efficacy of the 2 different treatment groups.
- To assess and compare the safety of the 2 different treatment groups.
Study Design: 6 visits over 62 weeks
- Conditions
- Keratosis, Actinic Keratosis
- Being tested
- Imiquimod used as an adjunct to cryotherapy
- Keywords
- Actinic Keratosis, Cryotherapy, Imiquimod
- Medical subject headings
- Keratosis, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod used as an adjunct to cryotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate and time to recurrence of lesions
Secondary outcomes (3)
Time to reach treatment success
Percentage of patients who clear
Patient improvement assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2005 (estimated)
- Study startApr 2005
- Primary completionOct 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratosisStudies 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
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Derm Research @ 888 Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Investigators
- Yves Poulin, MD FRCPC, Principal investigator, Centre de Recherche Dermatologique du Quebec MetropolitaineJerry KL Tan, MD FDRPC, Principal investigator, U. of Western Ontario, Windsor OntarioRichard Thomas, MD FRCPC, Principal investigator, Derm Research @ 888 Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110682
- Sponsor's protocol ID
- DR 2004-05
- Status last verified
- Apr 2008
- First submitted
- 12 May 2005
- Last updated
- 24 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Vehicle-Controlled, Double-Blind Study of Topical Imiquimod 5% Cream Used as an Adjunct to Cryotherapy in the Management of Actinic Keratoses, With a Long-Term (1 Year) Follow-Up
- ClinicalTrials.gov ID
- NCT00110682
- Acronym / sponsor ID
- DR 2004-05
- Conditions
- Keratosis, Actinic Keratosis
- Keywords
- Actinic Keratosis, Cryotherapy, Imiquimod
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Derm Research @ 888 Inc.Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Apr 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 13 May 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.
Study Aims:
- To compare the long-term efficacy and safety of imiquimod versus vehicle used as an adjunct to cryotherapy.
- To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups.
Hypothesis: The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses (AK) compared to the vehicle arm.
Detailed description
Evaluation of: (i) topical imiquimod 5% cream or (ii) vehicle cream used two times weekly for eight weeks starting two weeks post cryotherapy.
Study Aims:
- To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups.
- To assess and compare the efficacy of the 2 different treatment groups.
- To assess and compare the safety of the 2 different treatment groups.
Study Design: 6 visits over 62 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double 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 actinic keratosis with 4 or more discreet lesions on the face or balding scalp. Lesions must be within a treatment area not exceeding 50 cm2 (combined total must not exceed 50 cm2)
- Women of childbearing potential using appropriate contraceptive methods
Key exclusion criteria (3 listed)
- Previous treatments with imiquimod for AK in the prescribed area within the past 5 months or cryosurgery in the same area within the past 4 weeks.
- Patients unwilling to stay out of the sun or wear protective clothing or to use sunscreen with a minimum of SPF 15 during the study.
- Basal or squamous cell carcinomas in the prescribed treatment area in the past 2 years.
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 used as an adjunct to cryotherapy | Drug | – |
Primary outcome
Recurrence rate and time to recurrence of lesions
3 secondary outcomes
Time to reach treatment success
Percentage of patients who clear
Patient improvement assessment
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 24 Apr 2008.
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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.
Yves Poulin, MD FRCPC principal investigator
Centre de Recherche Dermatologique du Quebec Metropolitaine
Jerry KL Tan, MD FDRPC principal investigator
U. of Western Ontario, Windsor Ontario
Richard Thomas, MD FRCPC principal investigator
Derm Research @ 888 Inc.
3 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 used as an adjunct to cryotherapy in people with Keratosis and Actinic Keratosis, run by Derm Research @ 888 Inc. at 3 sites in Canada.
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 3 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 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Recurrence rate and time to recurrence of lesions. 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 Apr 2008; AzTrials last refreshed its copy on 8 Nov 2026.