- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01203878
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Colorado
-
Englewood, Colorado, United States, 80113
- AboutSkin Dermatology and DermSurgery, PC
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28207
- Dermatology, Laser & Vein Specialists of the Carolinas
-
-
Tennessee
-
Nashville, Tennessee, United States, 37215
- Tennessee Clinical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female adults; 18 and over
- At least 10 and no more than 30 clinically typical actinic keratoses on the face
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Imiquimod & photodynamic therapy
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
|
Administered 4 weeks after completion of imiquimod therapy
Other Names:
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
Other Names:
|
ACTIVE_COMPARATOR: Imiquimod
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
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Week 18 (4 weeks after randomization visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Clearance
Time Frame: Week 18 (4 weeks after randomization visit)
|
The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).
|
Week 18 (4 weeks after randomization visit)
|
Cosmetic Appearance
Time Frame: Week 18 (4 weeks after randomization visit)
|
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 |
Week 18 (4 weeks after randomization visit)
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Michael Gold, MD, Tennessee Clinical Research Center
- Principal Investigator: Joel Cohen, MD, AboutSkin Dermatology and DermSurgery, PC
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09US05N375-Gold
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Actinic Keratosis
-
Dolorgiet GmbH & Co. KGd.s.h. statistical services GmbH; CenTrial GmbHCompletedActinic Keratosis Olsen Grade I/IIGermany
-
Cosmetique Active InternationalNot yet recruiting
-
Centre Dermatologique du RoyCompleted
-
Encube Ethicals Pvt. Ltd.CBCC Global ResearchCompleted
-
University of California, DavisActive, not recruiting
-
Northwestern UniversityWithdrawn
-
Tulane UniversityMayne Pharma International Pty LtdTerminatedActinic KeratosesUnited States
-
Medical University of ViennaTerminatedActinic KeratosesAustria
-
University Hospital RegensburgGerman Research FoundationCompleted
-
St Vincent's University Hospital, IrelandCompleted
Clinical Trials on Photodynamic therapy
-
Centre Hospitalier Universitaire de NiceWithdrawnDystrophic Epidermolysis BullosaFrance
-
Northwestern UniversityCompleted
-
Bispebjerg HospitalCompletedActinic KeratosesDenmark
-
Bispebjerg HospitalCompleted
-
National Taiwan University HospitalCompleted
-
photonamic GmbH & Co. KGCompletedActinic KeratosisGermany
-
University of KansasDUSA Pharmaceuticals, Inc.CompletedHidradenitis SuppurativaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedRecurrent Non-small Cell Lung Cancer | Stage 0 Non-small Cell Lung Cancer | Squamous Cell Lung Cancer | Adenocarcinoma of the Lung | Large Cell Lung CancerUnited States
-
Fujian Longhua Pharmaceutical Co. LtdSun Yat-sen University; Fuzhou UniversityUnknownEsophageal Cancer | Skin CancerChina
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedAggressive PeriodontitisBrazil