Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
Information source: Tennessee Clinical Research Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Actinic Keratosis
Intervention: Imiquimod/photodynamic therapy (Drug); Imiquimod only (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Tennessee Clinical Research Center Official(s) and/or principal investigator(s):
Michael Gold, MD, Study Chair, Affiliation: Tennessee Clinical Research Center
Joel Cohen, MD, Principal Investigator, Affiliation: AboutSkin Dermatology and DermSurgery, PC
Girish Munavalli, MD, Principal Investigator, Affiliation: Dermatology, Laser & Vein Specialists of the Carolinas
Overall contact:
Julie Biron, Phone: 615-383-9660, Email: jbiron@goldskincare.com
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Actinic keratosis count
Secondary outcome: Complete clearanceCosmetic appearance
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 keratosss. 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 will be randomized to either
photodynamic therapy or observation.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Julie Biron, Phone: 615-383-9660, Email: jbiron@goldskincare.com
AboutSkin Dermatology and DermSurgery, PC, Englewood, Colorado 80113, United States; Recruiting
Brynne Shoaf, Phone: 303-756-7546, Email: bshoaf@aboutskinderm.com
Joel Cohen, MD, Principal Investigator
Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, North Carolina 28207, United States; Recruiting
Cindy Tucker, Phone: 704-375-6766, Ext: 3537, Email: nurse@carolinaskin.com
Girish Munavalli, M.D., Principal Investigator
Tennessee Clinical Research Center, Nashville, Tennessee 37215, United States; Recruiting
Brynne Thompson, Phone: 615-383-9660, Email: bthompson@goldskincare.com
Michael Gold, MD, Principal Investigator
Additional Information
Starting date: September 2010
Last updated: July 19, 2011
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