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Transcriptional Profiling of the Epidermal Response to Solar-Simulated Ultraviolet Radiation


N/A
18 Years
45 Years
Not Enrolling
Both
Non-melanomatous Skin Cancer, Precancerous Condition

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Trial Information

Transcriptional Profiling of the Epidermal Response to Solar-Simulated Ultraviolet Radiation


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Jonathan C. Vogel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Dermatology Branch

Authority:

United States: Federal Government

Study ID:

CDR0000357437

NCT ID:

NCT00099112

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Non-melanomatous Skin Cancer
  • Precancerous Condition
  • basal cell carcinoma of the skin
  • squamous cell carcinoma of the skin
  • actinic keratosis
  • Skin Neoplasms
  • Precancerous Conditions

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182