Actinic KeratosisPhase 2NCT00335179
Cellular and Molecular Events During Treatment of Actinic Keratosis With Imiquimod 5% Cream
A Phase 2 study testing Aldara (imiquimod 5% cream) in people with Actinic Keratosis, run by Graceway Pharmaceuticals, LLC at 1 site in United States.
Trial summary
Treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes that are turned on, and turned off, by skin cells. Some of the drug induced changes in skin cells should also be visible using a special microscope. This study examines both types of changes. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Aldara (imiquimod 5% cream)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jul 2003
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have actinic keratoses on balding scalp
- Discontinuation of tanning bed use
- Discontinuation of moisturizers
- Avoidance of retinol products
Who cannot join
- Uncontrolled, clinically significant medical condition
- Dermatologic disease other than actinic keratosis in treatment area
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92350
About this study
Official title: Double-Blind, Vehicle-Controlled Study to Evaluate Cellular and Molecular Events During Four Weeks of Treatment for Actinic Keratosis With Aldara (Imiquimod) Cream, 5%
Treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes that are turned on, and turned off, by skin cells. Some of the drug induced changes in skin cells should also be visible using a special microscope. This study examines both types of changes.
Read the detailed description
The primary objective of this study was to assess apoptosis by examining the gene expression profiles of actinic keratosis (AK) lesions that were treated with imiquimod 5% cream or vehicle cream once daily 3 times per week for 4 weeks. Secondary objectives were to assess the utility of confocal microscopy (CM) to visually track cellular response to treatment with study cream compared with clinical and histological evaluations, and to evaluate the safety of treatment with imiquimod in subjects with AK on the balding scalp.
- Conditions
- Actinic Keratosis
- Being tested
- Aldara (imiquimod 5% cream), Vehicle cream
- Keywords
- Actinic keratosis, AK, imiquimod, confocal microscopy, gene microarray
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aldara (imiquimod 5% cream)Drug
Also called imiquimod cream
Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream
Vehicle creamDrug
Also called placebo cream
Vehicle cream in 250 mg
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod cream | Active comparator | Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream Applied 3 times per week for 4 weeks Receives: Drug: Aldara (imiquimod 5% cream) |
| Vehicle cream | Placebo comparator | Vehicle cream 250 mg Applied 3 times per week for 4 weeks Receives: Drug: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression profiling of treated lesions
Measured: weeks 1, 2, and 4, and at 4 weeks post-treatment
Secondary outcomes (1)
Confocal microscopic evaluation before, during and post treatment
Measured: weeks 1, 2, 4 and at 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startJan 2003
- Primary completionJul 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Actinic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Graceway Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- TC Meng, MD, Study director, Graceway Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335179
- Sponsor's protocol ID
- 1467-IMIQ
- Status last verified
- Jul 2010
- First submitted
- 8 Jun 2006
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Torres A, Storey L, Anders M, Miller RL, Bulbulian BJ, Jin J, Raghavan S, Lee J, Slade HB, Birmachu W. Microarray analysis of aberrant gene expression in actinic keratosis: effect of the Toll-like receptor-7 agonist imiquimod. Br J Dermatol. 2007 Dec;157(6):1132-47. doi: 10.1111/j.1365-2133.2007.08218.x. Epub 2007 Oct 18.
PubMed 17944981Torres A, Storey L, Anders M, Miller RL, Bulbulian BJ, Jin J, Raghavan S, Lee J, Slade HB, Birmachu W. Immune-mediated changes in actinic keratosis following topical treatment with imiquimod 5% cream. J Transl Med. 2007 Jan 26;5:7. doi: 10.1186/1479-5876-5-7.
PubMed 17257431
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Vehicle-Controlled Study to Evaluate Cellular and Molecular Events During Four Weeks of Treatment for Actinic Keratosis With Aldara (Imiquimod) Cream, 5%
- ClinicalTrials.gov ID
- NCT00335179
- Acronym / sponsor ID
- 1467-IMIQ
- Conditions
- Actinic Keratosis
- Keywords
- Actinic keratosis, AK, imiquimod, confocal microscopy, gene microarray
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Graceway Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 9 Jun 2006 (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.
Treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes that are turned on, and turned off, by skin cells. Some of the drug induced changes in skin cells should also be visible using a special microscope. This study examines both types of changes.
Detailed description
The primary objective of this study was to assess apoptosis by examining the gene expression profiles of actinic keratosis (AK) lesions that were treated with imiquimod 5% cream or vehicle cream once daily 3 times per week for 4 weeks. Secondary objectives were to assess the utility of confocal microscopy (CM) to visually track cellular response to treatment with study cream compared with clinical and histological evaluations, and to evaluate the safety of treatment with imiquimod in subjects with AK on the balding scalp.
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 |
|---|---|---|
| Imiquimod cream | Active comparator | Drug: Aldara (imiquimod 5% cream)Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream Applied 3 times per week for 4 weeks |
| Vehicle cream | Placebo comparator | Drug: Vehicle creamVehicle cream 250 mg Applied 3 times per week for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have actinic keratoses on balding scalp
- Discontinuation of tanning bed use
- Discontinuation of moisturizers
- Avoidance of retinol products
Key exclusion criteria (2 listed)
- Uncontrolled, clinically significant medical condition
- Dermatologic disease other than actinic keratosis in treatment area
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 |
|---|---|---|
| Aldara (imiquimod 5% cream)Also: imiquimod creamImiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream | Drug | Imiquimod cream |
| Vehicle creamAlso: placebo creamVehicle cream in 250 mg | Drug | Vehicle cream |
Primary outcome
Gene expression profiling of treated lesions
Time frame: weeks 1, 2, and 4, and at 4 weeks post-treatment
1 secondary outcome
Confocal microscopic evaluation before, during and post treatment
Time frame: weeks 1, 2, 4 and at 4 weeks post-treatment
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 23 Jul 2010.
- Background: PubMed 17944981Torres A, Storey L, Anders M, Miller RL, Bulbulian BJ, Jin J, Raghavan S, Lee J, Slade HB, Birmachu W. Microarray analysis of aberrant gene expression in actinic keratosis: effect of the Toll-like receptor-7 agonist imiquimod. Br J Dermatol. 2007 Dec;157(6):1132-47. doi: 10.1111/j.1365-2133.2007.08218.x. Epub 2007 Oct 18.
- Background: PubMed 17257431Torres A, Storey L, Anders M, Miller RL, Bulbulian BJ, Jin J, Raghavan S, Lee J, Slade HB, Birmachu W. Immune-mediated changes in actinic keratosis following topical treatment with imiquimod 5% cream. J Transl Med. 2007 Jan 26;5:7. doi: 10.1186/1479-5876-5-7.
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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.
TC Meng, MD study director
Graceway Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aldara (imiquimod 5% cream) in people with Actinic Keratosis, run by Graceway Pharmaceuticals, LLC at 1 site 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 4 inclusion and 2 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 23 Jul 2010. 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 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 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?
Gene expression profiling of treated lesions (time frame: weeks 1, 2, and 4, and at 4 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00335179, which also lists 2 linked publications.
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 Jul 2010.