Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099112
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2004-12-08
Brief Title:
Effect of Solar-Simulated Ultraviolet Radiation on Gene Expression in Unprotected and Sunscreen-Protected Skin of Healthy Adults With Fitzpatrick Skin Type II
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Transcriptional Profiling of the Epidermal Response to Solar-Simulated Ultraviolet Radiation
Status:
COMPLETED
Status Verified Date:
2005-11
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:
RATIONALE Testing of skin that has been exposed to artificial sunlight may help in understanding the genetic processes involved in the development of skin cancer
PURPOSE This trial is studying the effect of solar-simulated ultraviolet radiation on skin with or without sunscreen in healthy adults with skin that burns easily after only slight tanning during sun exposure
PURPOSE This trial is studying the effect of solar-simulated ultraviolet radiation on skin with or without sunscreen in healthy adults with skin that burns easily after only slight tanning during sun exposure
Detailed Description:
OBJECTIVES
Determine the global gene expression profiles in epidermal tissue of healthy fair-skinned adults with Fitzpatrick skin type II after exposure to known doses of solar-simulated ultraviolet radiation ssUVR UVA
Determine the ability of an FDA-standardized sunscreen to alter ssUVR-induced transcription profiles in vivo in these participants
Determine whether the transcriptional profiles of keratinocytes exposed to UVR in cell culture are comparable to the profiles of keratinocytes in skin after similar levels of UVR exposure
OUTLINE This is a pilot dose-response study followed by an in vivo transcriptional profiling study in 2 different groups
Pilot study verification of ultraviolet radiation dose response Participants are initially exposed to solar-simulated ultraviolet radiation ssUVR UVA on the back to determine the minimum erythema dose MED Between 22-24 hours after exposure participants undergo shave biopsy from each of the 9 UV exposure sites and 1 unexposed skin site
Group 1 determination of ssUVR and UVA in vivo transcriptional profiles On day 1 participants are initially exposed to ssUVR on the back to determine the MED On day 2 participants are exposed to ssUVR 3 sites and UVA 3 sites at the MED on the buttocks Between 22-24 hours after exposure day 3 participants undergo shave biopsy from each of the 6 UV exposure sites and 2 unexposed skin sites
Group 2 determination of sunscreen-protected in vivo transcriptional profiles On day 1 participants are initially exposed to ssUVR on the back to determine the MED On day 2 participants are exposed to ssUVR on unprotected skin 3 sites and sunscreen-protected skin 3 sites at the MED on the buttocks Between 22-24 hours after exposure day 3 participants undergo shave biopsy from each of the 6 UV exposure sites and 2 unexposed skin sites
Biopsies from all participants are analyzed by microarray analysis One of the unexposed epidermal samples is used for primary keratinocyte culture
PROJECTED ACCRUAL A total of 6-56 participants 6 for the pilot study and 50 25 per group for transcriptional profiling will be accrued for this study within 2 months
Determine the global gene expression profiles in epidermal tissue of healthy fair-skinned adults with Fitzpatrick skin type II after exposure to known doses of solar-simulated ultraviolet radiation ssUVR UVA
Determine the ability of an FDA-standardized sunscreen to alter ssUVR-induced transcription profiles in vivo in these participants
Determine whether the transcriptional profiles of keratinocytes exposed to UVR in cell culture are comparable to the profiles of keratinocytes in skin after similar levels of UVR exposure
OUTLINE This is a pilot dose-response study followed by an in vivo transcriptional profiling study in 2 different groups
Pilot study verification of ultraviolet radiation dose response Participants are initially exposed to solar-simulated ultraviolet radiation ssUVR UVA on the back to determine the minimum erythema dose MED Between 22-24 hours after exposure participants undergo shave biopsy from each of the 9 UV exposure sites and 1 unexposed skin site
Group 1 determination of ssUVR and UVA in vivo transcriptional profiles On day 1 participants are initially exposed to ssUVR on the back to determine the MED On day 2 participants are exposed to ssUVR 3 sites and UVA 3 sites at the MED on the buttocks Between 22-24 hours after exposure day 3 participants undergo shave biopsy from each of the 6 UV exposure sites and 2 unexposed skin sites
Group 2 determination of sunscreen-protected in vivo transcriptional profiles On day 1 participants are initially exposed to ssUVR on the back to determine the MED On day 2 participants are exposed to ssUVR on unprotected skin 3 sites and sunscreen-protected skin 3 sites at the MED on the buttocks Between 22-24 hours after exposure day 3 participants undergo shave biopsy from each of the 6 UV exposure sites and 2 unexposed skin sites
Biopsies from all participants are analyzed by microarray analysis One of the unexposed epidermal samples is used for primary keratinocyte culture
PROJECTED ACCRUAL A total of 6-56 participants 6 for the pilot study and 50 25 per group for transcriptional profiling will be accrued for this study within 2 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-04-C-0120 | None | None | None |