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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 clearance

Cosmetic 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

Page last updated: February 07, 2013

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