Clinical trial · Interventional
The Effect of Efudex Treatment on Photoaged Skin
The Effect of Efudex (5-fluorouracil) Treatment on Photoaged Skin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Keratosis | — | UNRESOLVED | — |
| Photo-aging | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Efudex (5-fluorouracil) | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Actinic Keratoses resolution and improvement in photoaging
Secondary outcomes (2)
- measure
- Changes in p53 immunostaining intensity will be used to assess response
- measure
- Collagen production will be evaluated by Western blotting, immunohistology, and RT-PCR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available