Actinic KeratosesNCT01502020
A Bioequivalence Study With Clinical Endpoints Comparing Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses
A study testing imiquimod cream, 3.75% in people with Actinic Keratoses, run by Actavis Mid-Atlantic LLC at 19 sites in United States.
Trial summary
Zyclara™ (imiquimod) Cream, 3.75% is approved by the FDA for the treatment of actinic keratoses on the full face or balding scalp. Zyclara is applied once daily for two, 2-week treatment cycles separated by a 2-week no treatment applied interval. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- imiquimod cream, 3.75%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 19 sitesUnited States
- Study dates
- Feb 2011to Nov 2011
- Phase
- Interventional
- 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
- Subject was male or female, 18 years of age or older.
- Subject provided written informed consent.
- Subject was willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- Subject had a clinical diagnosis of actinic keratoses (AK) with at least five (5) and no more than 20 clinically typical, visible or palpable AK lesions, each at least 4mm in diameter, in an area greater than 25cm2 on the face (excluding ears) or balding scalp, but not both.
- Subject was in good general health and free of any disease state or physical condition that might have impaired evaluation of AK lesions or which, in the investigator's opinion, exposed the subject to an unacceptable risk by study participation.
- If subject was a woman of childbearing potential (WOCBP), she must have had a negative urine pregnancy test (UPT) and agreed to use an effective form of birth control for the duration of the study (e.g., abstinence, stabilized on hormonal contraceptives for at least three months [oral, implant, injection, IUD, patch or NuvaRing] condom and spermicidal or diaphragm and spermicidal). Abstinence was an acceptable form of birth control for subjects who were not sexually active. Subjects who became sexually active during the trial had to agree to use an effective, non-prohibited form of birth control for the duration of the study.
Who cannot join
- Subject was pregnant, lactating, or planning to become pregnant during the study.
- Subjects had hyperkeratotic, hypertrophic or atypical AKs (e.g., AK > 1 cm2 in size) in the Treatment Area.
- Subject was enrolled in an investigational drug or device study during the study period.
- Subject was planning to be exposed to artificial tanning devices or excessive sunlight during the trial.
- Subject was immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease, etc.).
- Subject had experienced an unsuccessful outcome from previous imiquimod therapy (An unsuccessful outcome was defined as after a reasonable therapeutic trial with no compliance issues, topical application did not work).
Show all 17Show fewer
- Subject had used an investigational drug or investigational device within 30 days prior to the Baseline Visit.
- Subject had laser resurfacing, PUVA (Psoralen + ultraviolet A) therapy, UVB therapy, chemical peels or dermabrasion on the face or balding scalp within 6 months prior to the Baseline Visit.
- Subject had cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision or other treatments for actinic keratosis on the face or scalp within one month prior to the Baseline Visit.
- Subject had used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies or retinoids within one month prior to the Baseline Visit.
- Subject had used topical medications, corticosteroids, alpha hydroxy acids (e.g., glycolic acid, lactic acid etc. > 5%), beta hydroxy acid (salicylic acid > 2%), urea >5%, 5-fluorouracil, diclofenac, imiquimod or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the face or balding scalp within one month prior to the Baseline Visit.
- Subject had used topical creams, lotions or gels of any kind to the selected Treatment Area within one day prior to the Baseline Visit.
- Subject had a basal cell or squamous cell carcinoma within the Treatment Area within one year of study enrollment.
- Subject had a history of sensitivity to any of the ingredients in the test articles.
- Subject had any skin pathology or condition (e.g., facial/scalp psoriasis, atopic dermatitis, acne, rosacea, etc.) that, in the investigator's opinion, could have interfered with the evaluation of the test article, worsened due to the treatment or required the use of interfering topical, systemic or surgical therapy.
- Subject had any condition which, in the investigator's opinion, would have made it unsafe or precluded the subject's ability to fully participate in the research study.
- Subject was known to be noncompliant or was unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
DermResearch, Inc.
Austin, Texas, 78759
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
Northwest Clinical Trials
Boise, Idaho, 83704
Dermatology, Laser & Vein Specialists of the Carolinas,
Charlotte, North Carolina, 28207
Dermatology Research Center of Cincinnati
Cincinnati, Ohio, 45220
Michigan Center for Research Corp.
Clinton Township, Michigan, 48038
Deaconess Clinic, Inc.
Evansville, Indiana, 47713
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, 19034
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Suzanne Bruce and Associates, P.A.
Houston, Texas, 77056
Dermatology Specialists
Louisville, Kentucky, 40202
International Dermatology Research, Inc.
Miami, Florida, 33144
MedaPhase, Inc.
Newnan, Georgia, 30263
Skin Specialists, P.C.
Omaha, Nebraska, 68144
Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Oregon Medical Research Center, PC
Portland, Oregon, 97223
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses
Zyclara™ (imiquimod) Cream, 3.75% is approved by the FDA for the treatment of actinic keratoses on the full face or balding scalp. Zyclara is applied once daily for two, 2-week treatment cycles separated by a 2-week no treatment applied interval. A generic imiquimod cream, 3.75% has been developed by Actavis Mid-Atlantic LLC for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp.
The current clinical study is designed to evaluate the therapeutic equivalence of this formulation with the currently marketed Zyclara™ (imiquimod) cream, 3.75% formulation (Graceway Pharmaceuticals LLC).
- Conditions
- Actinic Keratoses
- Being tested
- imiquimod cream, 3.75%, Vehicle Cream
- Keywords
- actinic keratoses, actinic keratosis, imiquimod, 3.75%, imiquimod, Zyclara, Actinic keratoses of the face or balding scalp
- 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 cream, 3.75%Drug
Dosage form: Topical Cream Dosage: 3.75% Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.
Vehicle CreamDrug
Dosage form: Topical Cream Dosage: Placebo Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.
imiquimod cream, 3.75%Drug
Dosage form: Topical Cream Dosage: 3.75% Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Zyclara™ | Active comparator | Not described Receives: Drug: imiquimod cream, 3.75% |
| Generic Imiquimod Cream, 3.75% | Experimental | Not described Receives: Drug: imiquimod cream, 3.75% |
| Vehicle Cream | Placebo comparator | Not described Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clearance rate
Complete clearance rate (treatment success) was defined as the proportion of subjects in a treatment group with 100% clearance of all AK lesions within the Treatment Area. The primary efficacy endpoint was the proportion of subjects in the per-protocol (PP) population with treatment success at Week 14/EOS. All AKs (Baseline and new lesions), independent of size, within the Treatment Area were included in the AK lesion counts.
Measured: 8 weeks post treatment period
Dosing Compliance
Measures of test article compliance included the total number of days of test article applications recorded on the CRFs and verified from the data in the subject diaries. Compliant subjects were defined as those who applied at least 75% and no more than 125% of the test article applications.
Measured: 8 weeks post treatment period
Adverse Events
The severity and frequency of adverse events (AEs) were assessed in the three treatment groups.
Measured: 14 weeks
Local Skin Reactions
The severity and frequency of local skin reactions (LSRs) were assessed in the three treatment groups.
Measured: 14 weeks
Secondary outcomes (2)
Partial Clearance Rate
Partial clearance rate was defined as the proportion of subjects in a treatment group with 75% or more reduction in the AK count in the Treatment Area at Week 14/EOS as compared to Baseline.
Measured: 8 weeks post treatment
Percent Change in the AK number
Percent change in the AK number as compared to Baseline at Week 14/EOS was a secondary outcome.
Measured: 8 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 posted30 Dec 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Mid-Atlantic LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Piacquadio, M.D., Study director, Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502020
- Sponsor's protocol ID
- 094-3152-301
- Status last verified
- Dec 2011
- First submitted
- 23 Dec 2011
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses
- ClinicalTrials.gov ID
- NCT01502020
- Acronym / sponsor ID
- 094-3152-301
- Conditions
- Actinic Keratoses
- Keywords
- actinic keratoses, actinic keratosis, imiquimod, 3.75%, imiquimod, Zyclara, Actinic keratoses of the face or balding scalp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Actavis Mid-Atlantic LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Dec 2011 (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.
Zyclara™ (imiquimod) Cream, 3.75% is approved by the FDA for the treatment of actinic keratoses on the full face or balding scalp. Zyclara is applied once daily for two, 2-week treatment cycles separated by a 2-week no treatment applied interval. A generic imiquimod cream, 3.75% has been developed by Actavis Mid-Atlantic LLC for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp.
The current clinical study is designed to evaluate the therapeutic equivalence of this formulation with the currently marketed Zyclara™ (imiquimod) cream, 3.75% formulation (Graceway Pharmaceuticals LLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zyclara™ | Active comparator | Drug: imiquimod cream, 3.75% |
| Generic Imiquimod Cream, 3.75% | Experimental | Drug: imiquimod cream, 3.75% |
| Vehicle Cream | Placebo comparator | Drug: Vehicle Cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject was male or female, 18 years of age or older.
- Subject provided written informed consent.
- Subject was willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- Subject had a clinical diagnosis of actinic keratoses (AK) with at least five (5) and no more than 20 clinically typical, visible or palpable AK lesions, each at least 4mm in diameter, in an area greater than 25cm2 on the face (excluding ears) or balding scalp, but not both.
- Subject was in good general health and free of any disease state or physical condition that might have impaired evaluation of AK lesions or which, in the investigator's opinion, exposed the subject to an unacceptable risk by study participation.
Key exclusion criteria (17 listed)
- Subject was pregnant, lactating, or planning to become pregnant during the study.
- Subjects had hyperkeratotic, hypertrophic or atypical AKs (e.g., AK > 1 cm2 in size) in the Treatment Area.
- Subject was enrolled in an investigational drug or device study during the study period.
- Subject was planning to be exposed to artificial tanning devices or excessive sunlight during the trial.
- Subject was immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease, etc.).
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 cream, 3.75%Dosage form: Topical Cream Dosage: 3.75% Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period. | Drug | Zyclara™ |
| Vehicle CreamDosage form: Topical Cream Dosage: Placebo Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period. | Drug | Vehicle Cream |
| imiquimod cream, 3.75%Dosage form: Topical Cream Dosage: 3.75% Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period. | Drug | Generic Imiquimod Cream, 3.75% |
Primary outcome
Complete clearance rate
Time frame: 8 weeks post treatment period
Complete clearance rate (treatment success) was defined as the proportion of subjects in a treatment group with 100% clearance of all AK lesions within the Treatment Area. The primary efficacy endpoint was the proportion of subjects in the per-protocol (PP) population with treatment success at Week 14/EOS. All AKs (Baseline and new lesions), independent of size, within the Treatment Area were included in the AK lesion counts.
Dosing Compliance
Time frame: 8 weeks post treatment period
Measures of test article compliance included the total number of days of test article applications recorded on the CRFs and verified from the data in the subject diaries. Compliant subjects were defined as those who applied at least 75% and no more than 125% of the test article applications.
Adverse Events
Time frame: 14 weeks
The severity and frequency of adverse events (AEs) were assessed in the three treatment groups.
Local Skin Reactions
Time frame: 14 weeks
The severity and frequency of local skin reactions (LSRs) were assessed in the three treatment groups.
2 secondary outcomes
Partial Clearance Rate
Time frame: 8 weeks post treatment
Percent Change in the AK number
Time frame: 8 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 30 Dec 2011.
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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.
Daniel Piacquadio, M.D. study director
Therapeutics, Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imiquimod cream, 3.75% in people with Actinic Keratoses, run by Actavis Mid-Atlantic LLC at 19 sites 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 6 inclusion and 17 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 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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.
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?
Complete clearance rate (time frame: 8 weeks post treatment period). The study lists 4 primary outcomes in all. 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 30 Dec 2011.