Actinic KeratosisPhase 3NCT00294320
Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions
A Phase 3 study testing Aldara (Imiquimod) in people with Actinic Keratosis, run by MEDA Pharma GmbH & Co. KG at 1 site in France.
Trial summary
The purpose of this study is to evaluate the performance of two techniques to monitor the clearance of AK lesions when treated with Aldara 5% cream. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Aldara (Imiquimod)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2006to Jan 2007
- Phase
- Phase 3
- 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
- At least 5 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions
- Free of any significant findings (e.g tattoos) in the potential application site area.
- Willing to discontinue sun-tanning and use of sunbed/sun parlour use
- Willing to stop use of moisturisers, body oils, and over the counter retinol products or products containing alpha or beta hydroxyacids in the treatment or surrounding area.
- Willing ot withhold sunscreen and/or moisturiser use for 24 hours prior to each clinical assessment
Who cannot join
- Evidence of unstable or uncontrolled clinically significant medical condition.
- Any dermatological disease and or condition in the treatment of the surrounding area that may be exacerbated by treatment with imiquimod.
- Currently participating in another clinical study or have completed another study within an investigational drug within the past 30 days.
- Have active chemical dependency or alcoholism
- Have know allergies to any excipient or study cream
- Have received previous treatment with imiquimod for any indication within the treatment area.
- Known to be affected by porphyria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions (Clinical and Sub-clinical), When Treated With Aldara 5% (Imiquimod) Cream
The purpose of this study is to evaluate the performance of two techniques to monitor the clearance of AK lesions when treated with Aldara 5% cream.
Read the detailed description
Each technique will be assessed by comparison of lesion counts (clinical and sub-clinical) revealed by the techniques, at start and end of the study and those demonstrated during treatment. In addition a qualitative assessment of each technique will be made for performance and ease of use.
- Conditions
- Actinic Keratosis
- Being tested
- Aldara (Imiquimod), Vehicle cream
- Keywords
- Aldara, Actinic Keratosis
- 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)Drug
250mg of Imiquimod cream for application once daily 3 times per week.
Vehicle creamOther
250mg vehicle cream for application once daily 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 250mg of Imiquimod cream application once daily 3 times per week. Receives: Drug: Aldara (Imiquimod) |
| 2 | Placebo comparator | 250mg vehicle cream for application once daily 3 times per week. Receives: Other: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the performance of two techniques to monitor the clearance of AK lesions (clinical and subclinical) when treated with Aldara 5% cream by comparison of lesion counts.
Measured: 8 weeks after the end of treatment
Secondary outcomes (1)
To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.
Measured: 8 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Paul Ortonne, Professor, Principal investigator, CPCAD, Hopital L'Archet 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294320
- Sponsor's protocol ID
- 1517-IMIQ
- Status last verified
- Sep 2008
- First submitted
- 21 Feb 2006
- 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
- Pilot Study to Evaluate Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions (Clinical and Sub-clinical), When Treated With Aldara 5% (Imiquimod) Cream
- ClinicalTrials.gov ID
- NCT00294320
- Acronym / sponsor ID
- 1517-IMIQ
- Conditions
- Actinic Keratosis
- Keywords
- Aldara, Actinic Keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 22 Feb 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.
The purpose of this study is to evaluate the performance of two techniques to monitor the clearance of AK lesions when treated with Aldara 5% cream.
Detailed description
Each technique will be assessed by comparison of lesion counts (clinical and sub-clinical) revealed by the techniques, at start and end of the study and those demonstrated during treatment. In addition a qualitative assessment of each technique will be made for performance and ease of use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Aldara (Imiquimod)250mg of Imiquimod cream application once daily 3 times per week. |
| 2 | Placebo comparator | Other: Vehicle cream250mg vehicle cream for application once daily 3 times per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 5 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions
- Free of any significant findings (e.g tattoos) in the potential application site area.
- Willing to discontinue sun-tanning and use of sunbed/sun parlour use
- Willing to stop use of moisturisers, body oils, and over the counter retinol products or products containing alpha or beta hydroxyacids in the treatment or surrounding area.
- Willing ot withhold sunscreen and/or moisturiser use for 24 hours prior to each clinical assessment
Key exclusion criteria (7 listed)
- Evidence of unstable or uncontrolled clinically significant medical condition.
- Any dermatological disease and or condition in the treatment of the surrounding area that may be exacerbated by treatment with imiquimod.
- Currently participating in another clinical study or have completed another study within an investigational drug within the past 30 days.
- Have active chemical dependency or alcoholism
- Have know allergies to any excipient or study cream
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)250mg of Imiquimod cream for application once daily 3 times per week. | Drug | 1 |
| Vehicle cream250mg vehicle cream for application once daily 3 times per week. | Other | 2 |
Primary outcome
To compare the performance of two techniques to monitor the clearance of AK lesions (clinical and subclinical) when treated with Aldara 5% cream by comparison of lesion counts.
Time frame: 8 weeks after the end of treatment
1 secondary outcome
To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.
Time frame: 8 weeks after the end of 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 7 Feb 2022.
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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.
Jean-Paul Ortonne, Professor principal investigator
CPCAD, Hopital L'Archet 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aldara (Imiquimod) in people with Actinic Keratosis, run by MEDA Pharma GmbH & Co. KG at 1 site in France.
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 5 inclusion and 7 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 1 site in France. 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?
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?
To compare the performance of two techniques to monitor the clearance of AK lesions (clinical and subclinical) when treated with Aldara 5% cream by comparison of lesion counts. (time frame: 8 weeks after the end of treatment). 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.