The Effect of Efudex Treatment on Photoaged Skin

NCT00121511 | Completed

• 2 other identifiers: Derm 5492005-0368
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers propose that skin improvements may be seen following a course of Efudex, (5-fluorouracil), a FDA-approved topical therapy (applied directly to the skin). These improvements could be the result of both a reduction of actinic keratoses (small red horny growths or flesh-colored wartlike growths caused by overexposure to ultraviolet radiation or the sun) and improvement of sun-damaged skin. In addition, this research study is being done to determine if the expression of p53, a tumor suppressor gene (its activity stops the formation of tumors), is decreased following Efudex treatment. Mutations (abnormal changes) in the gene, called p53, are associated with a certain type of skin cancer. In addition, p53-mutated genes are known to exist in non-cancerous sun-damaged skin. Thus, the presence of p53 mutations may serve as a marker for both sun damage and an elevated risk of developing skin cancer.

Conditions

Photo-aging; Keratosis

Keywords

photoaging; Actinic Keratoses; Efudex; 5 fluorouracil

Outcome Measures

Primary Outcomes (1)

• Actinic Keratoses resolution and improvement in photoaging

Secondary Outcomes (2)

• Changes in p53 immunostaining intensity will be used to assess response

• Collagen production will be evaluated by Western blotting, immunohistology, and RT-PCR

Interventions

Efudex (5-fluorouracil) DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 or older of either gender.
• Patients must have actinic keratoses
• Patients must have clinical photoaging judged by rhytides, dyspigmentation, poikiloderma, lentigines, skin thinning, and/or telangiectases.
• Subjects must be in generally good health and willing to undergo skin biopsies from the face.
• Subjects must be willing and able to comply with the requirements of the protocol.
• You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

You may not qualify if:

• Oral retinoid therapy (such as Accutane) within two months of study entry.
• Topical retinoid, imiquimod, or diclofenac therapy within 2 months of study entry.
• Prior laser re-surfacing, chemical peels for actinic keratoses or aging skin.
• Pregnant or nursing subjects.
• Non-compliant subjects.
• Subjects with a significant medical history or concurrent illness that the investigator feels is not safe for study participation.
• Prior systemic treatment with 5-fluorouracil.
• Known history of allergy to lidocaine (numbing medication), 5-fluoruracil, or any other known components of Efudex.

Sponsors & Collaborators

• University of Michigan: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Keratosis; Keratosis, Actinic

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Precancerous Conditions; Neoplasms

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• John J Voorhees, MD

  University of Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology, Medical School

Study Record Dates

• First Submitted: July 13, 2005
• First Posted: July 21, 2005
• Study Start: July 1, 2005
• Study Completion: July 1, 2007
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (1)