Status:
TERMINATED
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
Lead Sponsor:
Tennessee Clinical Research Center
Collaborating Sponsors:
Graceway Pharmaceuticals, LLC
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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
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 fo...
Eligibility Criteria
Inclusion
- Male and female adults; 18 and over
- At least 10 and no more than 30 clinically typical actinic keratoses on the face
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01203878
Start Date
September 1 2010
End Date
November 1 2011
Last Update
December 8 2014
Active Locations (3)
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1
AboutSkin Dermatology and DermSurgery, PC
Englewood, Colorado, United States, 80113
2
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 28207
3
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215