Overview

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