Actinic KeratosisPhase 3NCT00859105
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis
A Phase 3 study testing Imiquimod 5%: manufactured by Apotex, Adara 5% Cream US and Adara 5% Cream Canada in people with Actinic Keratosis, run by Apotex Inc..
Trial summary
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Imiquimod 5%: manufactured by Apotex, Adara 5% Cream US and Adara 5% Cream Canada
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 497 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Nov 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp
- Women either must be 1 year post-menopausal, surgically sterile, or agree to use a medically accepted form or birth control
- Free of any systemic or dermatological disorder
- Any skin type or race, providing the skin pigmentation will allow discernment of erythema
Who cannot join
- Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp)
- History of cutaneous hyperreactivity or facial irritation to topical products
- Engaging in activities involving excessive or prolonged exposure to sunlight
- Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry
- Currently using or have used systemic steroids 2 months prior to study
- Currently using or have used on the treatment area over-the-counter retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic keratosis treatments 28 days prior to randomization
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- Pregnant or nursing mothers
- History of allergy or sensitivity to imiquimod or related compounds or other components of the formulation
- Taking immunosuppressant medication
About this study
Official title: A Multicenter, Double-Blind, Vehical-Controlled Study Comparing Imiquimod Cream, 5% (Apotex Inc.) to Aldara™ Cream, 5%(3M Pharmaceutials, U.S.) and Aldara™ Cream, 5%(3M Pharmaceuticals, Canada) in the Treatments of Actinic Keratosis.
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study
- Conditions
- Actinic Keratosis
- Being tested
- Imiquimod 5%: manufactured by Apotex, Adara 5% Cream US, Adara 5% Cream Canada, Imiquimod Vehicle
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod 5%: manufactured by ApotexDrug
Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks
Adara 5% Cream USDrug
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
Adara 5% Cream CanadaDrug
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.
Imiquimod VehicleDrug
Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod 5% | Experimental | Manufactured by Apotex Receives: Drug: Imiquimod 5%: manufactured by Apotex |
| Adara 5 % Cream US | Active comparator | Manufactured by 3M, US. Receives: Drug: Adara 5% Cream US |
| Adara 5% Cream Canada | Active comparator | Manufactured by 3M, Canada Receives: Drug: Adara 5% Cream Canada |
| Vehicle | Placebo comparator | Manufactured by Apotex Receives: Drug: Imiquimod Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Apotex Inc. and two Aldara (imiquimod) creams, manufactured by 3M (US & Canada) , and to show superiority over vehicle in the treatment of AK.
Measured: 24 weeks
Secondary outcomes (1)
The secondary objective is to compare the safety profiles of the three creams.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startFeb 2008
- Primary completionNov 2008
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apotex Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Brooks, Study director, Apotex Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859105
- Sponsor's protocol ID
- IMIQ-TOCR-01RB01-CE
- Status last verified
- Mar 2009
- First submitted
- 9 Mar 2009
- Last updated
- 10 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Vehical-Controlled Study Comparing Imiquimod Cream, 5% (Apotex Inc.) to Aldara™ Cream, 5%(3M Pharmaceutials, U.S.) and Aldara™ Cream, 5%(3M Pharmaceuticals, Canada) in the Treatments of Actinic Keratosis.
- ClinicalTrials.gov ID
- NCT00859105
- Acronym / sponsor ID
- IMIQ-TOCR-01RB01-CE
- Conditions
- Actinic Keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Apotex Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- First posted
- 10 Mar 2009 (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, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Imiquimod 5% | Experimental | Drug: Imiquimod 5%: manufactured by ApotexManufactured by Apotex |
| Adara 5 % Cream US | Active comparator | Drug: Adara 5% Cream USManufactured by 3M, US. |
| Adara 5% Cream Canada | Active comparator | Drug: Adara 5% Cream CanadaManufactured by 3M, Canada |
| Vehicle | Placebo comparator | Drug: Imiquimod VehicleManufactured by Apotex |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp
- Women either must be 1 year post-menopausal, surgically sterile, or agree to use a medically accepted form or birth control
- Free of any systemic or dermatological disorder
- Any skin type or race, providing the skin pigmentation will allow discernment of erythema
Key exclusion criteria (9 listed)
- Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp)
- History of cutaneous hyperreactivity or facial irritation to topical products
- Engaging in activities involving excessive or prolonged exposure to sunlight
- Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study entry
- Currently using or have used systemic steroids 2 months prior to study
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 5%: manufactured by ApotexTreatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks | Drug | Imiquimod 5% |
| Adara 5% Cream USTreatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks | Drug | Adara 5 % Cream US |
| Adara 5% Cream CanadaTreatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks. | Drug | Adara 5% Cream Canada |
| Imiquimod VehicleTreatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks | Drug | Vehicle |
Primary outcome
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Apotex Inc. and two Aldara (imiquimod) creams, manufactured by 3M (US & Canada) , and to show superiority over vehicle in the treatment of AK.
Time frame: 24 weeks
1 secondary outcome
The secondary objective is to compare the safety profiles of the three creams.
Time frame: 24 weeks
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 10 Mar 2009.
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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.
William Brooks study director
Apotex Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imiquimod 5%: manufactured by Apotex, Adara 5% Cream US and Adara 5% Cream Canada in people with Actinic Keratosis, run by Apotex Inc..
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 9 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 10 Mar 2009. 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. 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?
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Apotex Inc. and two Aldara (imiquimod) creams, manufactured by 3M (US & Canada) , and to show superiority over vehicle in the treatment of AK. (time frame: 24 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 10 Mar 2009; AzTrials last refreshed its copy on 30 Oct 2026.