Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121511
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2005-07-13
Brief Title:
The Effect of Efudex Treatment on Photoaged Skin
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
The Effect of Efudex 5-fluorouracil Treatment on Photoaged Skin
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1950s 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-0368 | None | None | None |