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

This study has been terminated.
(Unable to reach target enrollment of 60 subjects)
Sponsor:
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by (Responsible Party):
Tennessee Clinical Research Center
ClinicalTrials.gov Identifier:
NCT01203878
First received: September 15, 2010
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Actinic Keratosis
Drug: Photodynamic therapy
Drug: Imiquimod
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tennessee Clinical Research Center:

Primary Outcome Measures:
  • Actinic keratosis count [ Time Frame: Week 18 (4 weeks after randomization visit) ] [ Designated as safety issue: No ]
    The percent change in actinic keratosis count as compared to the baseline lesion count


Secondary Outcome Measures:
  • Complete clearance [ Time Frame: Week 18 (4 weeks after randomization visit) ] [ Designated as safety issue: No ]
    The proportion of patients with complete clearance of actinic keratoses in the treatment area (entire face)

  • Cosmetic appearance [ Time Frame: Week 18 (4 weeks after randomization visit) ] [ Designated as safety issue: No ]
    Change in investigator and patient scores of cosmetic appearance of the treatment area (entire face)


Enrollment: 21
Study Start Date: September 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imiquimod & photodynamic therapy
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
Drug: Photodynamic therapy
Administered 4 weeks after completion of imiquimod therapy
Other Name: Levulan Kerasticks (aminolevulinic acid 20% solution)
Drug: Imiquimod
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
Other Name: Zyclara (imiquimod 3.75% cream)
Active Comparator: Imiquimod
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
Drug: Imiquimod
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
Other Name: Zyclara (imiquimod 3.75% cream)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203878

Locations
United States, Colorado
AboutSkin Dermatology and DermSurgery, PC
Englewood, Colorado, United States, 80113
United States, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 28207
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Tennessee Clinical Research Center
Graceway Pharmaceuticals, LLC
Investigators
Study Chair: Michael Gold, MD Tennessee Clinical Research Center
Principal Investigator: Joel Cohen, MD AboutSkin Dermatology and DermSurgery, PC
Principal Investigator: Girish Munavalli, MD Dermatology, Laser & Vein Specialists of the Carolinas
  More Information

No publications provided

Responsible Party: Tennessee Clinical Research Center
ClinicalTrials.gov Identifier: NCT01203878     History of Changes
Other Study ID Numbers: 09US05N375-Gold
Study First Received: September 15, 2010
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tennessee Clinical Research Center:
Imiquimod
Photodynamic therapy
Actinic keratoses
Sequential therapy
Therapeutic uses

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Aminolevulinic Acid
Imiquimod
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers

ClinicalTrials.gov processed this record on August 18, 2014