Actinic KeratosesPhase 4NCT00774787
Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses
A Phase 4 study testing imiquimod 5% cream in people with Actinic Keratoses, run by Rigel Dermatology at 3 sites in United States.
Trial summary
The purpose of this study is to determine if use of topical imiquimod cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) at follow-up. 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 5% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2008to Mar 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- A clinical diagnosis of actinic keratoses
- Actinic keratoses in two reasonably bilaterally symmetric areas on the face and/or balding scalp:
- each area with a minimum of 25 cm^2 and a maximum of 50 cm^2
- each area with at least 6 typical, non-hypertrophic target AKs
- with target AK lesion counts of +/- 1 lesion between the areas
- each area that the patient can distinguish with respect to study drug application
- Able to comply with all study requirements
- Are willing and able to give written informed consent
Who cannot join
- Uncontrolled intercurrent or chronic illness
- Systemic immunocompromise due to disease or treatment
- Clinically relevant systemic autoimmune disease
- Pregnant or nursing
- Dermatologic disease and/or condition in the treatment area that may be exacerbated by imiquimod or cause difficulty with examination
- Participation in another clinical study
Show all 26Show fewer
- Allergies to imiquimod or any of the excipients in the cream
- Treatment within the past 90 days with any of the following:
- Psoralens plus ultraviolet A therapy
- Ultraviolet B therapy
- Systemic immunomodulators (e.g. oral or parenteral corticosteroids at greater than physiologic doses, interferons, anti-TNF agents, cytokines)
- Chemotherapeutic or cytotoxic agents;
- Investigational agent
- Treatment within the past 30 days with any of the following:
- Surgical excision
- Photodynamic therapy
- Curettage
- Topical corticosteroids
- Laser
- Dermabrasion
- Chemical peel
- Imiquimod 5% cream
- Topical retinoids
- 5-fluorouracil
- Masoprocol
- Pimecrolimus or tacrolimus
Trial locations and contacts
3 sites in 1 country.
United States3 sites
James Del Rosso
Henderson, Nevada, 89129
Rigel Dermatology
New York, New York, 10016
Spencer Dermatology and Skin Surgery
St. Petersburg, Florida, 33716
About this study
Official title: A Randomized, Open-label, Assessor-blinded, Split-face Study of Imiquimod 5% Cream Applied After Cryotherapy of Actinic Keratoses
The purpose of this study is to determine if use of topical imiquimod cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) at follow-up.
Read the detailed description
Actinic keratoses are common skin lesions associated with excess sun exposure. Over time, there is a small risk a lesion may progress to skin cancer. Since one can not predict which actinic keratosis will progress, the standard of care is to treat the lesions. The most commonly used method to treat actinic keratoses in the United States is with cryotherapy, which uses intense cold to freeze and destroy the lesions. Efficacy appears to be related to how long one freezes the lesion, but increasing the freeze time may result in increased pain and/or skin pigment changes after treatment.
Cryotherapy is a provider-administered "focal" treatment that only treats the lesions that are frozen. There may be early actinic keratoses in the skin surrounding treated lesions that are not easily seen; these may progress over time to visible lesions. There several patient-administered topical treatments for actinic keratoses that are applied to a treatment area or "field" rather than to specific lesions. Imiquimod 5% cream is one such treatment, and is approved in the United States for the treatment of AKs with a dosing regimen of 1 packet applied 2 times per week to a 25 cm2 area 2x/week for 16 weeks.
The study will use a split-face design (one side of face treated and the other side untreated) to explore whether a 4-week course of topical imiquimod 5% cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) in the treatment area at follow-up.
- Conditions
- Actinic Keratoses
- Being tested
- imiquimod 5% cream
- Keywords
- Combination treatment, Imiquimod, Cryotherapy
- 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% creamDrug
Also called Aldara
1 packet (250 mg cream) 3 times per week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod, treatment, topical cream | Experimental | Imiquimod 5% cream, 1 packet (250 mg cream), applied to left or right treatment area on the face and/or balding scalp Receives: Drug: imiquimod 5% cream |
| Control, Untreated | No intervention | No treatment of treatment area on the other half of the face and/or balding scalp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment
Percent change = [(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)]/(actinic keratoses count at baseline)]*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.
Measured: Baseline, 4-8 weeks post-treatment
Secondary outcomes (1)
Cosmetic Appearance Score at 4-8 Weeks Post-treatment
Cosmetic appearance score, based recall comparison to appearance at baseline. Seven point scale: +3 = treatment area is much better appearing; +2 = treatment area is moderately better appearing; + 1 = treatment area is slightly better appearing; 0 = treatment area appears same; -1 = treatment area is slightly worse appearing; -2 = treatment area is moderately worse appearing; -3 = treatment area is much worse appearing. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.
Measured: 4-8 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 posted17 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rigel Dermatology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darrell S. Rigel, Rigel Dermatology
- Investigators
- Darrell S Rigel, MD, Study chair, Rigel DermatologyJames Q Del Rosso, DO, Principal investigator, Private PracticeJames Spencer, Principal investigator, Spencer Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774787
- Sponsor's protocol ID
- 08US02IMIQ-Rigel
- Status last verified
- Oct 2016
- First submitted
- 16 Oct 2008
- Last updated
- 7 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Assessor-blinded, Split-face Study of Imiquimod 5% Cream Applied After Cryotherapy of Actinic Keratoses
- ClinicalTrials.gov ID
- NCT00774787
- Acronym / sponsor ID
- 08US02IMIQ-Rigel
- Conditions
- Actinic Keratoses
- Keywords
- Combination treatment, Imiquimod, Cryotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Rigel DermatologyUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Posted 27 Oct 2010
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 determine if use of topical imiquimod cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) at follow-up.
Detailed description
Actinic keratoses are common skin lesions associated with excess sun exposure. Over time, there is a small risk a lesion may progress to skin cancer. Since one can not predict which actinic keratosis will progress, the standard of care is to treat the lesions. The most commonly used method to treat actinic keratoses in the United States is with cryotherapy, which uses intense cold to freeze and destroy the lesions. Efficacy appears to be related to how long one freezes the lesion, but increasing the freeze time may result in increased pain and/or skin pigment changes after treatment.
Cryotherapy is a provider-administered "focal" treatment that only treats the lesions that are frozen. There may be early actinic keratoses in the skin surrounding treated lesions that are not easily seen; these may progress over time to visible lesions. There several patient-administered topical treatments for actinic keratoses that are applied to a treatment area or "field" rather than to specific lesions. Imiquimod 5% cream is one such treatment, and is approved in the United States for the treatment of AKs with a dosing regimen of 1 packet applied 2 times per week to a 25 cm2 area 2x/week for 16 weeks.
The study will use a split-face design (one side of face treated and the other side untreated) to explore whether a 4-week course of topical imiquimod 5% cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) in the treatment area at follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imiquimod, treatment, topical cream | Experimental | Drug: imiquimod 5% creamImiquimod 5% cream, 1 packet (250 mg cream), applied to left or right treatment area on the face and/or balding scalp |
| Control, Untreated | No intervention | –No treatment of treatment area on the other half of the face and/or balding scalp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A clinical diagnosis of actinic keratoses
- Actinic keratoses in two reasonably bilaterally symmetric areas on the face and/or balding scalp:
- Able to comply with all study requirements
- Are willing and able to give written informed consent
Key exclusion criteria (26 listed)
- Uncontrolled intercurrent or chronic illness
- Systemic immunocompromise due to disease or treatment
- Clinically relevant systemic autoimmune disease
- Pregnant or nursing
- Dermatologic disease and/or condition in the treatment area that may be exacerbated by imiquimod or cause difficulty with examination
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% creamAlso: Aldara1 packet (250 mg cream) 3 times per week for 4 weeks | Drug | Imiquimod, treatment, topical cream |
Primary outcome
Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment
Time frame: Baseline, 4-8 weeks post-treatment
Percent change = [(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)]/(actinic keratoses count at baseline)]*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.
1 secondary outcome
Cosmetic Appearance Score at 4-8 Weeks Post-treatment
Time frame: 4-8 weeks post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Darrell S Rigel, MD study chair
Rigel Dermatology
James Q Del Rosso, DO principal investigator
Private Practice
James Spencer principal investigator
Spencer Dermatology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing imiquimod 5% cream in people with Actinic Keratoses, run by Rigel Dermatology at 3 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 8 inclusion and 26 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment (time frame: Baseline, 4-8 weeks post-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 Nov 2016.