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Effect of Solar-Simulated Ultraviolet Radiation on Gene Expression in Unprotected and Sunscreen-Protected Skin of Healthy Adults With Fitzpatrick Skin Type II

Primary Purpose

Non-melanomatous Skin Cancer, Precancerous Condition

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
microarray analysis
biopsy
evaluation of cancer risk factors
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Non-melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin, squamous cell carcinoma of the skin, actinic keratosis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

DISEASE CHARACTERISTICS: Healthy, fair-skinned adults Fitzpatrick skin type II by history and physical exam Skin easily burns, and tans only slightly, after sun exposure Test site for solar-simulated ultraviolet radiation exposure (buttocks) devoid of sunburn, suntan, scars, active dermal lesions, and uneven skin tones Nevi allowed at physician discretion Excess hair must be clipped or shaved No prior nonmelanoma skin cancer, melanoma, or dysplastic nevi PATIENT CHARACTERISTICS: Age 18 to 45 Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No prior malignancy No prior phototoxic, photoallergic, or other abnormal responses to sunlight No prior allergic reaction to sunscreen or lidocaine No underlying disease that is known to cause immunosuppression (e.g., HIV, cancer, or post-organ transplantation) No situation that would preclude study compliance Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 6 months since prior topical or systemic medication producing abnormal sunlight responses No concurrent medications with > 1% incidence of sun-related toxic effects No concurrent medications associated with abnormal light response No concurrent immunosuppressants No other concurrent ultraviolet radiation (e.g., sunlight or tanning bed) to the epidermal test site

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 8, 2004
Last Updated
April 29, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00099112
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
Official Title
Transcriptional Profiling of the Epidermal Response to Solar-Simulated Ultraviolet Radiation
Study Type
Observational

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanomatous Skin Cancer, Precancerous Condition
Keywords
basal cell carcinoma of the skin, squamous cell carcinoma of the skin, actinic keratosis

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
microarray analysis
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
evaluation of cancer risk factors

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
DISEASE CHARACTERISTICS: Healthy, fair-skinned adults Fitzpatrick skin type II by history and physical exam Skin easily burns, and tans only slightly, after sun exposure Test site for solar-simulated ultraviolet radiation exposure (buttocks) devoid of sunburn, suntan, scars, active dermal lesions, and uneven skin tones Nevi allowed at physician discretion Excess hair must be clipped or shaved No prior nonmelanoma skin cancer, melanoma, or dysplastic nevi PATIENT CHARACTERISTICS: Age 18 to 45 Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No prior malignancy No prior phototoxic, photoallergic, or other abnormal responses to sunlight No prior allergic reaction to sunscreen or lidocaine No underlying disease that is known to cause immunosuppression (e.g., HIV, cancer, or post-organ transplantation) No situation that would preclude study compliance Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 6 months since prior topical or systemic medication producing abnormal sunlight responses No concurrent medications with > 1% incidence of sun-related toxic effects No concurrent medications associated with abnormal light response No concurrent immunosuppressants No other concurrent ultraviolet radiation (e.g., sunlight or tanning bed) to the epidermal test site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan C. Vogel, MD
Organizational Affiliation
NCI - Dermatology Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effect of Solar-Simulated Ultraviolet Radiation on Gene Expression in Unprotected and Sunscreen-Protected Skin of Healthy Adults With Fitzpatrick Skin Type II

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