Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy

Stopped early · Phase 4

Conditions studied: Actinic Keratosis

In brief

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

Key facts

Study ID

NCT01203878

Run by

Tennessee Clinical Research Center

People needed

21

Starts

2010-09-01

Expected to finish

2011-11-01

Last updated by the study team

2014-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female adults; 18 and over
• At least 10 and no more than 30 clinically typical actinic keratoses on the face

You may not qualify if…

• 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

Where it is running

• AboutSkin Dermatology and DermSurgery, PC — Englewood, Colorado, United States
• Dermatology, Laser & Vein Specialists of the Carolinas — Charlotte, North Carolina, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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