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

• Status: Terminated
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tennessee Clinical Research Center
• Collaborator: Graceway Pharmaceuticals, LLC
• Treatments: Aminolevulinic Acid; Imiquimod

Criteria

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