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

• ClinicalTrials.gov Identifier: NCT01203878
• Recruitment Status: Terminated
• First Posted: September 17, 2010
• Results First Posted: November 20, 2014
• Last Update Posted: December 8, 2014
• Sponsor: Tennessee Clinical Research Center
• Collaborator: Graceway Pharmaceuticals, LLC
• Information provided by (Responsible Party): Tennessee Clinical Research Center

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

Condition or disease	Intervention/treatment	Phase
Actinic Keratosis	Drug: Photodynamic therapy; Drug: Imiquimod	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: September 2010
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: November 2011

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. Actinic Keratosis Count [ Time Frame: Week 18 (4 weeks after randomization visit) ]
   The percent change in actinic keratosis count as compared to the baseline lesion count

Secondary Outcome Measures :

1. Complete Clearance [ Time Frame: Week 18 (4 weeks after randomization visit) ]
   The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).
2. Cosmetic Appearance [ Time Frame: Week 18 (4 weeks after randomization visit) ]

   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Tennessee Clinical Research Center
• ClinicalTrials.gov Identifier: NCT01203878
• Other Study ID Numbers: 09US05N375-Gold
• First Posted: September 17, 2010
• Results First Posted: November 20, 2014
• Last Update Posted: December 8, 2014
• Last Verified: November 2014

Keywords provided by Tennessee Clinical Research Center:

Imiquimod; Photodynamic therapy; Actinic keratoses; Sequential therapy; Therapeutic uses

Additional relevant MeSH terms:

Keratosis, Actinic; Keratosis; Skin Diseases; Precancerous Conditions; Neoplasms; Imiquimod; Aminolevulinic Acid; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Antineoplastic Agents; Interferon Inducers; Photosensitizing Agents; Dermatologic Agents