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

Phase 4

Terminated

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 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Imiquimod & photodynamic therapy	Photodynamic therapy	Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
Imiquimod & photodynamic therapy	Imiquimod	Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
Imiquimod	Imiquimod	Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation

Primary Outcome Measures

Name	Time	Method
Actinic Keratosis Count	Week 18 (4 weeks after randomization visit)	The percent change in actinic keratosis count as compared to the baseline lesion count

Secondary Outcome Measures

Name	Time	Method
Cosmetic Appearance	Week 18 (4 weeks after randomization visit)	Change (improvement) in investigator scores of cosmetic appearance of the treatment area (entire face) by objective and subjective assessments: INVESTIGATOR COSMETIC ASSESSMENT 0 - Facial skin is smooth to the touch, without significant lines or unevenness in pigmentation 1 - Facial skin shows 1 area (cheeks, forehead, or the perioral area) of significant 3 - Facial skin shows 3 areas with significant roughness, dyspigmentation, or fine lines 2 - Facial skin shows 2 areas of significant roughness, dyspigmentation, or fine lines 4 - All are severe in severity
Complete Clearance	Week 18 (4 weeks after randomization visit)	The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).

Locations (3): 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