Photo-agingNCT00121511
The Effect of Efudex Treatment on Photoaged Skin
A study testing Efudex (5-fluorouracil) in people with Photo-aging and Keratosis, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photo-aging, Keratosis
- What is being tested?
- Efudex (5-fluorouracil)
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109
About this study
Official title: The Effect of Efudex (5-fluorouracil) Treatment on Photoaged Skin
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.
Read the 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 effective therapy. It requires, however, a high level of patient compliance and is known to cause a vigorous inflammatory reaction when actinic keratoses are treated. It has the distinct advantage of identifying precancerous skin lesions not apparent on clinical inspection or palpation. Following a course of Efudex to the face, patients have been noted to have fewer signs of dermatoheliosis.
The investigators propose to determine if Efudex is associated with improvement of aging skin in the setting of treating actinic keratoses. The researchers hope to demonstrate less p53 staining following Efudex treatment. It is proposed that the skin improvements seen following a course of Efudex are due to both reduction of actinic keratoses and impact on photoaging. The researchers propose to quantify the effects of Efudex therapy on the immunohistochemical staining properties of facial skin with respect to p53 and procollagen. The hypothesis is that Efudex therapy will decrease p53 immunostaining thus providing biochemical evidence to support this treatment in the reduction of actinic keratoses with concomitant improvement of aging skin.
- Conditions
- Photo-aging, Keratosis
- Being tested
- Efudex (5-fluorouracil)
- Keywords
- photoaging, Actinic Keratoses, Efudex, 5 fluorouracil
- Medical subject headings
- Keratosis, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efudex (5-fluorouracil)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJul 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photo-agingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Principal investigator, Dana L. Sachs, MD, University of Michigan
- Investigators
- John J Voorhees, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121511
- Sponsor's protocol ID
- Derm 549
- Other IDs
- 2005-0368
- Status last verified
- May 2015
- First submitted
- 13 Jul 2005
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Efudex (5-fluorouracil) Treatment on Photoaged Skin
- ClinicalTrials.gov ID
- NCT00121511
- Acronym / sponsor ID
- Derm 549
- Conditions
- Photo-aging, Keratosis
- Keywords
- photoaging, Actinic Keratoses, Efudex, 5 fluorouracil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- Jul 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 21 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 effective therapy. It requires, however, a high level of patient compliance and is known to cause a vigorous inflammatory reaction when actinic keratoses are treated. It has the distinct advantage of identifying precancerous skin lesions not apparent on clinical inspection or palpation. Following a course of Efudex to the face, patients have been noted to have fewer signs of dermatoheliosis.
The investigators propose to determine if Efudex is associated with improvement of aging skin in the setting of treating actinic keratoses. The researchers hope to demonstrate less p53 staining following Efudex treatment. It is proposed that the skin improvements seen following a course of Efudex are due to both reduction of actinic keratoses and impact on photoaging. The researchers propose to quantify the effects of Efudex therapy on the immunohistochemical staining properties of facial skin with respect to p53 and procollagen. The hypothesis is that Efudex therapy will decrease p53 immunostaining thus providing biochemical evidence to support this treatment in the reduction of actinic keratoses with concomitant improvement of aging skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efudex (5-fluorouracil) | Drug | – |
Primary outcome
Actinic Keratoses resolution and improvement in photoaging
2 secondary outcomes
Changes in p53 immunostaining intensity will be used to assess response
Collagen production will be evaluated by Western blotting, immunohistology, and RT-PCR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Voorhees, MD study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efudex (5-fluorouracil) in people with Photo-aging and Keratosis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actinic Keratoses resolution and improvement in photoaging. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.