Actinic KeratosisPhase 1NCT01788007
Clinical Study to Evaluate the Bioequivalence of Two Imiquimod Cream 3.75% Formulations in Patients With Actinic Keratosis.
A Phase 1 study testing Imiquimod Topical Cream 3.75% and Zyclara® (imiquimod) Topical Cream 3.75% in people with Actinic Keratosis, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The objective of this study is to compare the relative efficacy and safety of the test formulation Imiquimod 3.75% Topical Cream to the marketed formulation Zyclara® (imiquimod) 3.75% Topical Cream in the treatment of actinic keratosis. 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?
- Imiquimod Topical Cream 3.75% and Zyclara® (imiquimod) Topical Cream 3.75%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 443 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2013
- Phase
- Phase 1
- 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
- Signed informed consent form.
- Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.
- Diagnosis of actinic keratosis with at least 5 and no more than 20 clinically typical, visible or palpable actinic keratosis lesions, each at least 4 mm in diameter, in an area that exceeds 25 cm2 on either the face (excluding ear) or balding scalp (but not both.)
- Women either must be 1 year post-menopausal, surgically sterile, or if they are of child-bearing potential, they must: a) have been using systemic birth control, intrauterine device, or Norplant for at least 28 days prior to the start of treatment period, or used barrier methods consistently, at least 14 days before study cream administration; b) had a normal menstrual cycle for the month prior to the start of treatment; c) have a negative urine pregnancy test result upon entry into the study; d) agree to use a medically accepted form of birth control throughout the study period.
- Free from any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events.
- Any skin type or race, providing the skin pigmentation will allow discernment of erythema.
- Willingness and capability to cooperate to the extent and degree required by the protocol.
Who cannot join
- Presence of atopic dermatitis, basal cell carcinoma, squamous cell carcinoma, eczema, psoriasis, rosacea, sunburn or other possible confounding skin conditions on the face or bald scalp.
- Use within six months prior to baseline on the face or bald scalp of chemical peel, dermabrasion, laser abrasion, psoralen plus ultraviolet A therapy, or ultra violet B therapy.
- Use within one month prior to baseline on the face or bald scalp of cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision, topical 5-fluorouracil, topical corticosteroids, topical diclofenac, topical imiquimod, topical retinoids or other treatments for actinic keratosis including glycolic acids or over-the-counter products containing retinol, alpha or beta hydroxy acids.
- Use within one month prior to baseline of immunomodulators or immunosuppressive therapies, interferon, oral corticosteroids or cytotoxic drugs.
- Known allergies to imiquimod or any excipients to the test or reference creams.
- Receiving 5-fluorouracil or other systemic cancer chemotherapy within 6 months prior to study entry.
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- Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.
- Women who are pregnant or planning pregnancy or lactating during the study.
- Participation in any investigational drug study within 30 days of enrollment or previous participation in this study.
- Employees or family members of employees of the research center or Investigator.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Design, Multiple Site, Clinical Study to Evaluate the Bioequivalence of Two Imiquimod Cream 3.75% Formulations in Patients With Actinic Keratosis.
The objective of this study is to compare the relative efficacy and safety of the test formulation Imiquimod 3.75% Topical Cream to the marketed formulation Zyclara® (imiquimod) 3.75% Topical Cream in the treatment of actinic keratosis. Both the test and reference formulations will also be compared to a placebo cream to test for superiority.
- Conditions
- Actinic Keratosis
- Being tested
- Imiquimod Topical Cream 3.75%, Zyclara® (imiquimod) Topical Cream 3.75%, Vehicle Topical Cream
- Keywords
- Actinic Keratosis, Imiquimod Topical Cream 3.75%, Zyclara® (imiquimod) Topical Cream 3.75%
- 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 Topical Cream 3.75%Drug
Imiquimod Topical Cream 3.75% (Taro Pharmaceutical Industries Ltd.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period.
Zyclara® (imiquimod) Topical Cream 3.75%Drug
Zyclara® (imiquimod) Topical Cream 3.75% (Medicis Pharmaceutical Co.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period.
Vehicle Topical CreamDrug
Vehicle Topical Cream (Taro Pharmaceutical Industries Ltd.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod Topical Cream 3.75% | Experimental | Imiquimod Topical Cream 3.75% (Taro Pharmaceutical Industries Ltd.) Receives: Drug: Imiquimod Topical Cream 3.75% |
| Vehicle Topical Cream | Placebo comparator | Vehicle Topical Cream (Taro Pharmaceutical Industries Ltd.) Receives: Drug: Vehicle Topical Cream |
| Zyclara® (imiquimod) Topical Cream 3.75% | Active comparator | Zyclara® (imiquimod) Topical Cream 3.75% (Medicis Pharmaceutical Co.) Receives: Drug: Zyclara® (imiquimod) Topical Cream 3.75% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
Treatment success will be defined by the proportion of patients in the per protocol population with 100% clearance of all actinic keratosis lesions within the treatment area at study week 14 (8 weeks after completion of treatment.)
Measured: Week 14 (8 weeks after completion of treatment)
Secondary outcomes (1)
Superiority to placebo
The modified intent-to-treat population and last observation carried forward will be used to evaluate the superiority of both the test and reference product to placebo for the proportion of patients showing 100% clearance of actinic keratosis lesions at week 14 (8 weeks after completion of treatment.)
Measured: Week 14 (8 weeks after completion of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionDec 2013
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788007
- Sponsor's protocol ID
- IMQC 1220
- Status last verified
- Jan 2014
- First submitted
- 7 Feb 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Parallel Design, Multiple Site, Clinical Study to Evaluate the Bioequivalence of Two Imiquimod Cream 3.75% Formulations in Patients With Actinic Keratosis.
- ClinicalTrials.gov ID
- NCT01788007
- Acronym / sponsor ID
- IMQC 1220
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, Imiquimod Topical Cream 3.75%, Zyclara® (imiquimod) Topical Cream 3.75%
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Feb 2013 (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 objective of this study is to compare the relative efficacy and safety of the test formulation Imiquimod 3.75% Topical Cream to the marketed formulation Zyclara® (imiquimod) 3.75% Topical Cream in the treatment of actinic keratosis. Both the test and reference formulations will also be compared to a placebo cream to test for superiority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Imiquimod Topical Cream 3.75% | Experimental | Drug: Imiquimod Topical Cream 3.75%Imiquimod Topical Cream 3.75% (Taro Pharmaceutical Industries Ltd.) |
| Vehicle Topical Cream | Placebo comparator | Drug: Vehicle Topical CreamVehicle Topical Cream (Taro Pharmaceutical Industries Ltd.) |
| Zyclara® (imiquimod) Topical Cream 3.75% | Active comparator | Drug: Zyclara® (imiquimod) Topical Cream 3.75%Zyclara® (imiquimod) Topical Cream 3.75% (Medicis Pharmaceutical Co.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent form.
- Immunocompetent male or non-pregnant, non-lactating female at least 18 years of age.
- Diagnosis of actinic keratosis with at least 5 and no more than 20 clinically typical, visible or palpable actinic keratosis lesions, each at least 4 mm in diameter, in an area that exceeds 25 cm2 on either the face (excluding ear) or balding scalp (but not both.)
- Women either must be 1 year post-menopausal, surgically sterile, or if they are of child-bearing potential, they must: a) have been using systemic birth control, intrauterine device, or Norplant for at least 28 days prior to the start of treatment period, or used barrier methods consistently, at least 14 days before study cream administration; b) had a normal menstrual cycle for the month prior to the start of treatment; c) have a negative urine pregnancy test result upon entry into the study; d) agree to use a medically accepted form of birth control throughout the study period.
- Free from any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events.
Key exclusion criteria (10 listed)
- Presence of atopic dermatitis, basal cell carcinoma, squamous cell carcinoma, eczema, psoriasis, rosacea, sunburn or other possible confounding skin conditions on the face or bald scalp.
- Use within six months prior to baseline on the face or bald scalp of chemical peel, dermabrasion, laser abrasion, psoralen plus ultraviolet A therapy, or ultra violet B therapy.
- Use within one month prior to baseline on the face or bald scalp of cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision, topical 5-fluorouracil, topical corticosteroids, topical diclofenac, topical imiquimod, topical retinoids or other treatments for actinic keratosis including glycolic acids or over-the-counter products containing retinol, alpha or beta hydroxy acids.
- Use within one month prior to baseline of immunomodulators or immunosuppressive therapies, interferon, oral corticosteroids or cytotoxic drugs.
- Known allergies to imiquimod or any excipients to the test or reference creams.
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 Topical Cream 3.75%Imiquimod Topical Cream 3.75% (Taro Pharmaceutical Industries Ltd.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period. | Drug | Imiquimod Topical Cream 3.75% |
| Zyclara® (imiquimod) Topical Cream 3.75%Zyclara® (imiquimod) Topical Cream 3.75% (Medicis Pharmaceutical Co.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period. | Drug | Zyclara® (imiquimod) Topical Cream 3.75% |
| Vehicle Topical CreamVehicle Topical Cream (Taro Pharmaceutical Industries Ltd.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period. | Drug | Vehicle Topical Cream |
Primary outcome
Treatment success
Time frame: Week 14 (8 weeks after completion of treatment)
Treatment success will be defined by the proportion of patients in the per protocol population with 100% clearance of all actinic keratosis lesions within the treatment area at study week 14 (8 weeks after completion of treatment.)
1 secondary outcome
Superiority to placebo
Time frame: Week 14 (8 weeks after completion 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 22 Jan 2014.
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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 1 study testing Imiquimod Topical Cream 3.75% and Zyclara® (imiquimod) Topical Cream 3.75% in people with Actinic Keratosis, run by Sun Pharmaceutical Industries, 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 7 inclusion and 10 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 22 Jan 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Treatment success (time frame: Week 14 (8 weeks after completion 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 22 Jan 2014.