Actinic KeratosisPhase 4NCT01203878
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
A Phase 4 study testing Photodynamic therapy and Imiquimod in people with Actinic Keratosis, run by Tennessee Clinical Research Center at 3 sites in United States.
Trial summary
The purpose of this study is to explore the effect of treating actinic keratoses of the face with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone 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?
- Photodynamic therapy and Imiquimod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2010to Nov 2011
- 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
- Male and female adults; 18 and over
- At least 10 and no more than 30 clinically typical actinic keratoses on the face
Who cannot join
- Hypertrophic actinic keratoses or other skin lesions on the head that might required excluded treatment during the study
- Known contraindication to treatment with imiquimod or photodynamic therapy
- Condition that would limit compliance, be a potential safety risk, or require therapy with an excluded treatment
- Systemically immunocompromised
- Pregnant or nursing
- Dermatologic disease and/or condition in treatment area that might exacerbated by treatment with imiquimod, cause difficulty with examination, or require therapy with an excluded treatment
Show all 27Show fewer
- Participation in another clinical study
- Treatment within the past 60 days with:
- Ultraviolet therapy
- Systemic immunomodulators
- Chemotherapeutic or cytotoxic agents
- Investigational agents
- Treatment on the head within the past 60 days with:
- Imiquimod
- Photodynamic therapy
- Red or blue light source therapy
- Cryotherapy or chemotherapy
- Surgical excision or curettage
- Topical corticosteroids
- Laser
- Dermabrasion
- Chemical peel
- Topical retinoids
- Topical 5-fluorouracil
- Topical pimecrolimus or tacrolimus
- Topical diclofenac
- Treatment for actinic keratoses on the head within the past 60 days
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
AboutSkin Dermatology and DermSurgery, PC
Englewood, Colorado, 80113
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
About this study
Official title: An Exploratory, Open-label Study of Sequential Field-directed Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
The purpose of this study is to explore the effect of treating actinic keratoses of the face with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone
Read the detailed description
Actinic keratoses are common skin lesions associated with solar ultraviolet radiation exposure. Some actinic keratoses may develop into skin cancers.
Imiquimod 3.75% cream is an approved treatment for actinic keratoses that utilizes a regimen of application to the entire face or balding scalp of up to 2 packets of cream daily for two 2-week cycles, separated by a 2-week no treatment interval.
Photodynamic therapy with aminolevulinic acid (ALA) 20% topical solution is also an approved treatment for actinic keratoses. ALA is applied to actinic keratoses, and after an incubation period, is excited with light. Although approved as a lesion-directed treatment for actinic keratoses, treatment of a field (e.g. face) with photodynamic therapy is commonly performed.
Treatment with photodynamic therapy followed by imiquimod 5% cream has been reported in patients with actinic keratoses, basal cell carcinoma and Bowen's disease, and treatment with imiquimod 5% cream followed by photodynamic therapy in patients with vulvar intraepithelial neoplasia. There are, however, no prior studies on the safety and/or efficacy of using topical imiquimod 3.75% in conjunction with photodynamic therapy in the treatment of actinic keratoses.
This study will use an open-label parallel cohort design in which all patients will received treatment with imiquimod 3.75% cream, and subsequently will be randomized to either photodynamic therapy or observation.
- Conditions
- Actinic Keratosis
- Being tested
- Photodynamic therapy, Imiquimod
- Keywords
- Imiquimod, Photodynamic therapy, Actinic keratoses, Sequential therapy, Therapeutic uses
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyDrug
Also called Levulan Kerasticks (aminolevulinic acid 20% solution)
Administered 4 weeks after completion of imiquimod therapy
ImiquimodDrug
Also called Zyclara (imiquimod 3.75% cream)
Imiquimod 3.75% cream, up to 2 packets, applied topically daily for two 2-week cycles separated by a no-treatment interval of 2-weeks, followed observation
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod & photodynamic therapy | Experimental | Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light Receives: Drug: Photodynamic therapy; Drug: Imiquimod |
| Imiquimod | Active comparator | Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation Receives: Drug: Imiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actinic Keratosis Count
The percent change in actinic keratosis count as compared to the baseline lesion count
Measured: Week 18 (4 weeks after randomization visit)
Secondary outcomes (2)
Complete Clearance
The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).
Measured: Week 18 (4 weeks after randomization visit)
Cosmetic Appearance
Change (improvement) in investigator scores of cosmetic appearance of the treatment area (entire face) by objective and subjective assessments:
INVESTIGATOR COSMETIC ASSESSMENT 0 - Facial skin is smooth to the touch, without significant lines or unevenness in pigmentation
1 - Facial skin shows 1 area (cheeks, forehead, or the perioral area) of significant 3 - Facial skin shows 3 areas with significant roughness, dyspigmentation, or fine lines 2 - Facial skin shows 2 areas of significant roughness, dyspigmentation, or fine lines 4 - All are severe in severity
Measured: Week 18 (4 weeks after randomization visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Unable to reach target enrollment of 60 subjects
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tennessee Clinical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Graceway Pharmaceuticals, LLC
- Responsible party
- Sponsor
- Investigators
- Michael Gold, MD, Study chair, Tennessee Clinical Research CenterJoel Cohen, MD, Principal investigator, AboutSkin Dermatology and DermSurgery, PCGirish Munavalli, MD, Principal investigator, Dermatology, Laser & Vein Specialists of the Carolinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203878
- Sponsor's protocol ID
- 09US05N375-Gold
- Status last verified
- Nov 2014
- First submitted
- 15 Sep 2010
- Last updated
- 8 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open-label Study of Sequential Field-directed Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
- ClinicalTrials.gov ID
- NCT01203878
- Acronym / sponsor ID
- 09US05N375-Gold
- Conditions
- Actinic Keratosis
- Keywords
- Imiquimod, Photodynamic therapy, Actinic keratoses, Sequential therapy, Therapeutic uses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to reach target enrollment of 60 subjects
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tennessee Clinical Research CenterUniversity, hospital or other
- Collaborators
- Graceway Pharmaceuticals, LLC
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Posted 20 Nov 2014
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 explore the effect of treating actinic keratoses of the face with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone
Detailed description
Actinic keratoses are common skin lesions associated with solar ultraviolet radiation exposure. Some actinic keratoses may develop into skin cancers.
Imiquimod 3.75% cream is an approved treatment for actinic keratoses that utilizes a regimen of application to the entire face or balding scalp of up to 2 packets of cream daily for two 2-week cycles, separated by a 2-week no treatment interval.
Photodynamic therapy with aminolevulinic acid (ALA) 20% topical solution is also an approved treatment for actinic keratoses. ALA is applied to actinic keratoses, and after an incubation period, is excited with light. Although approved as a lesion-directed treatment for actinic keratoses, treatment of a field (e.g. face) with photodynamic therapy is commonly performed.
Treatment with photodynamic therapy followed by imiquimod 5% cream has been reported in patients with actinic keratoses, basal cell carcinoma and Bowen's disease, and treatment with imiquimod 5% cream followed by photodynamic therapy in patients with vulvar intraepithelial neoplasia. There are, however, no prior studies on the safety and/or efficacy of using topical imiquimod 3.75% in conjunction with photodynamic therapy in the treatment of actinic keratoses.
This study will use an open-label parallel cohort design in which all patients will received treatment with imiquimod 3.75% cream, and subsequently will be randomized to either photodynamic therapy or observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imiquimod & photodynamic therapy | Experimental | Drug: Photodynamic therapy, Drug: ImiquimodImiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light |
| Imiquimod | Active comparator | Drug: ImiquimodImiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female adults; 18 and over
- At least 10 and no more than 30 clinically typical actinic keratoses on the face
Key exclusion criteria (27 listed)
- Hypertrophic actinic keratoses or other skin lesions on the head that might required excluded treatment during the study
- Known contraindication to treatment with imiquimod or photodynamic therapy
- Condition that would limit compliance, be a potential safety risk, or require therapy with an excluded treatment
- Systemically immunocompromised
- Pregnant or nursing
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 |
|---|---|---|
| Photodynamic therapyAlso: Levulan Kerasticks (aminolevulinic acid 20% solution)Administered 4 weeks after completion of imiquimod therapy | Drug | Imiquimod & photodynamic therapy |
| ImiquimodAlso: Zyclara (imiquimod 3.75% cream)Imiquimod 3.75% cream, up to 2 packets, applied topically daily for two 2-week cycles separated by a no-treatment interval of 2-weeks, followed observation | Drug | Imiquimod, Imiquimod & photodynamic therapy |
Primary outcome
Actinic Keratosis Count
Time frame: Week 18 (4 weeks after randomization visit)
The percent change in actinic keratosis count as compared to the baseline lesion count
2 secondary outcomes
Complete Clearance
Time frame: Week 18 (4 weeks after randomization visit)
Cosmetic Appearance
Time frame: Week 18 (4 weeks after randomization visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- 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.
Michael Gold, MD study chair
Tennessee Clinical Research Center
Joel Cohen, MD principal investigator
AboutSkin Dermatology and DermSurgery, PC
Girish Munavalli, MD principal investigator
Dermatology, Laser & Vein Specialists of the Carolinas
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 Photodynamic therapy and Imiquimod in people with Actinic Keratosis, run by Tennessee Clinical Research Center 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 2 inclusion and 27 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: stopped early, as of the sponsor's last update on 8 Dec 2014. 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 20 Nov 2014). 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?
Actinic Keratosis Count (time frame: Week 18 (4 weeks after randomization visit)). 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 8 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.