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

NCT ID: NCT01203878

Last Updated: 2014-12-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-11-30

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.

Conditions

Actinic Keratosis

Keywords

Imiquimod; Photodynamic therapy; Actinic keratoses; Sequential therapy; Therapeutic uses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Imiquimod & 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

Group Type: EXPERIMENTAL

Photodynamic therapy

Intervention Type: DRUG

Administered 4 weeks after completion of imiquimod therapy

Imiquimod

Intervention Type: DRUG

Imiquimod 3.75% cream, up to 2 packets, applied topically daily for two 2-week cycles separated by a no-treatment interval of 2-weeks, followed observation

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

Group Type: ACTIVE_COMPARATOR

Imiquimod

Intervention Type: DRUG

Imiquimod 3.75% cream, up to 2 packets, applied topically daily for two 2-week cycles separated by a no-treatment interval of 2-weeks, followed observation

Interventions

Photodynamic therapy

Administered 4 weeks after completion of imiquimod therapy

Intervention Type: DRUG

Imiquimod

Imiquimod 3.75% cream, up to 2 packets, applied topically daily for two 2-week cycles separated by a no-treatment interval of 2-weeks, followed observation

Intervention Type: DRUG

Other Intervention Names

Levulan Kerasticks (aminolevulinic acid 20% solution); Zyclara (imiquimod 3.75% cream)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Graceway Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: collaborator

Tennessee Clinical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Gold, MD

Role: STUDY_CHAIR

Tennessee Clinical Research Center

Joel Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

AboutSkin Dermatology and DermSurgery, PC

Girish Munavalli, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology, Laser & Vein Specialists of the Carolinas

Locations

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

Countries

United States

Other Identifiers

09US05N375-Gold

Identifier Type: -

Identifier Source: org_study_id