Clinical trial NCT01203878: Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
Official title: An Exploratory, Open-label Study of Sequential Field-directed Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Actinic Keratosis
Keywords: Imiquimod
Photodynamic therapy
Actinic keratoses
Sequential therapy
Therapeutic uses
Lead sponsor: Tennessee Clinical Research Center
Sponsor class: OTHER
Collaborators: name: Graceway Pharmaceuticals, LLC
First posted: 2010-09-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Actinic Keratosis Count
timeFrame: Week 18 (4 weeks after randomization visit)
Secondary outcomes:
measure: Complete Clearance
timeFrame: Week 18 (4 weeks after randomization visit)
measure: Cosmetic Appearance
timeFrame: Week 18 (4 weeks after randomization visit)
Other outcomes:
Locations:
city: Englewood
country: United States
facility: AboutSkin Dermatology and DermSurgery, PC
state: Colorado
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
Study officials:
affiliation: Tennessee Clinical Research Center
name: Michael Gold, MD
role: STUDY_CHAIR
affiliation: AboutSkin Dermatology and DermSurgery, PC
name: Joel Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology, Laser & Vein Specialists of the Carolinas
name: Girish Munavalli, MD
role: PRINCIPAL_INVESTIGATOR
References: