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
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
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
NCT ID
NCT01203878
First Posted
September 15, 2010
Last Updated
November 20, 2014
Sponsor
Tennessee Clinical Research Center
Collaborators
Graceway Pharmaceuticals, LLC
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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