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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00099112
First received: December 8, 2004
Last updated: February 1, 2010
Last verified: November 2005
  Purpose

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.


Condition Intervention
Non-melanomatous Skin Cancer
Precancerous Condition
Genetic: microarray analysis
Procedure: biopsy
Procedure: evaluation of cancer risk factors

Study Type: Observational
Official Title: Transcriptional Profiling of the Epidermal Response to Solar-Simulated Ultraviolet Radiation

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099112

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Jonathan C. Vogel, MD NCI - Dermatology Branch
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00099112     History of Changes
Obsolete Identifiers: NCT00077740
Other Study ID Numbers: CDR0000357437, NCI-04-C-0120
Study First Received: December 8, 2004
Last Updated: February 1, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
basal cell carcinoma of the skin
squamous cell carcinoma of the skin
actinic keratosis

Additional relevant MeSH terms:
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014