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

Primary Purpose

Actinic Keratosis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Photodynamic therapy
Imiquimod
Sponsored by
Tennessee Clinical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Imiquimod, Photodynamic therapy, Actinic keratoses, Sequential therapy, Therapeutic uses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AboutSkin Dermatology and DermSurgery, PC
  • Dermatology, Laser & Vein Specialists of the Carolinas
  • Tennessee Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Imiquimod & photodynamic therapy

Imiquimod

Arm Description

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 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation

Outcomes

Primary Outcome Measures

Actinic Keratosis Count
The percent change in actinic keratosis count as compared to the baseline lesion count

Secondary Outcome Measures

Complete Clearance
The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).
Cosmetic Appearance
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

Full Information

First Posted
September 15, 2010
Last Updated
November 20, 2014
Sponsor
Tennessee Clinical Research Center
Collaborators
Graceway Pharmaceuticals, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01203878
Brief Title
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Unable to reach target enrollment of 60 subjects
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tennessee Clinical Research Center
Collaborators
Graceway Pharmaceuticals, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Imiquimod, Photodynamic therapy, Actinic keratoses, Sequential therapy, Therapeutic uses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imiquimod & photodynamic therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Imiquimod
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Photodynamic therapy
Other Intervention Name(s)
Levulan Kerasticks (aminolevulinic acid 20% solution)
Intervention Description
Administered 4 weeks after completion of imiquimod therapy
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Other Intervention Name(s)
Zyclara (imiquimod 3.75% cream)
Intervention Description
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
Primary Outcome Measure Information:
Title
Actinic Keratosis Count
Description
The percent change in actinic keratosis count as compared to the baseline lesion count
Time Frame
Week 18 (4 weeks after randomization visit)
Secondary Outcome Measure Information:
Title
Complete Clearance
Description
The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).
Time Frame
Week 18 (4 weeks after randomization visit)
Title
Cosmetic Appearance
Description
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
Time Frame
Week 18 (4 weeks after randomization visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gold, MD
Organizational Affiliation
Tennessee Clinical Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joel Cohen, MD
Organizational Affiliation
AboutSkin Dermatology and DermSurgery, PC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Girish Munavalli, MD
Organizational Affiliation
Dermatology, Laser & Vein Specialists of the Carolinas
Official's Role
Principal Investigator
Facility Information:
Facility Name
AboutSkin Dermatology and DermSurgery, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Dermatology, Laser & Vein Specialists of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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