Status:
COMPLETED
The Effect of Efudex Treatment on Photoaged Skin
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Photo-aging
Keratosis
Eligibility:
All Genders
50+ years
Phase:
NA
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 th...
Detailed Description
Efudex (5-fluorouracil) has been used as topical chemotherapy for the treatment of actinic keratoses (AKs) since the 1950's. Through many years of use, Efudex has been deemed to be a safe and effectiv...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00121511
Start Date
July 1 2005
End Date
July 1 2007
Last Update
May 27 2015
Active Locations (1)
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1
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109