Unable to reach target enrollment of 60 subjects

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

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.

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

Patients completing week 18 visit

18 weeks

From study entry (Visit 1) to end of study (visit 5).

Early termination (slow enrollment) leading to small numbers of subjects analyzed; missing measurement(s) on a patient