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
18 Years
N/A
Both
Actinic Keratosis
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Actinic keratosis count
Outcome Description:
The percent change in actinic keratosis count as compared to the baseline lesion count
Outcome Time Frame:
Week 18 (4 weeks after randomization visit)
Safety Issue:
No
Principal Investigator
Michael Gold, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Tennessee Clinical Research Center
Authority:
United States: Institutional Review Board
Study ID:
09US05N375-Gold
NCT ID:
NCT01203878
Start Date:
September 2010
Completion Date:
November 2011
Related Keywords:
- Actinic Keratosis
- Imiquimod
- Photodynamic therapy
- Actinic keratoses
- Sequential therapy
- Therapeutic uses
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Tennessee Clinical Research Center | Nashville, Tennessee 37221 |
| AboutSkin Dermatology and DermSurgery, PC | Englewood, Colorado 80113 |
| Dermatology, Laser & Vein Specialists of the Carolinas | Charlotte, North Carolina 28207 |
