Protocol Number: 04-C-0120

Title:

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

Number:

04-C-0120

Summary:

This study will explore the relationship between skin cancer and ultraviolet (UV) radiation exposure by measuring gene expression patterns in skin that has been exposed to UV light and comparing the results with patterns in skin protected by sunscreen.

Healthy fair-skinned adults between 18 and 45 years of age with skin type 2 (skin that burns and tans only slightly following sun exposure) may be eligible for this study. Candidates are screened with questionnaires related to their medical history, medicines they are taking, and their skin's response to sunlight.

Participants' skin response to UV light exposure will be evaluated with the following procedures, performed during three visits to the NIH Clinical Center:

Day 1: Skin sensitivity testing. Participants are exposed to artificial sunlight (UV light from a lamp) on eight areas of their back. Each area is 2 x 2 cm (less 1 x 1 inch) in size. Before and 24 hours after the exposure, photographs are taken of the study areas to record changes in redness.

Day 2: Skin response evaluation and additional testing. The skin response to the UV exposure on day 1 is measured and photographed. After the evaluation, six 2 x 2 cm areas of skin on the buttocks are exposed to UV light.

Day 3: Biopsies. Biopsies (small skin samples) are taken at each of the test sites on the buttocks and in two control (unexposed) areas near the test sites. For each biopsy, the skin is at the site is numbed with a lidocaine injection and a dermatologist scrapes a small amount of skin (about 4 mm, or 1/6-inch, in diameter) from the site. The wounds are then cleaned and bandaged.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

American Indian or Alaskan Native

Asian/Pacific Islander

Black (Not of Hispanic Origin)

Hispanic

Eligibility Criteria:

INCLUSION CRITERIA

1. Healthy fair-skinned adults (18-45 years of age) who have Fitzpatrick skin type II will be included. Skin type determined based on sunburn and tanning history as per the Fitzpatrick scale.

2. No history of taking any medications (topical or systemic) known to produce abnormal sunlight responses in the past 6 months. (Due to the large number of medications with reported phototoxic or photoallergic reactions, participant's medications will be screened per FDA Photoscience Facility protocol including review of participant medications using the Drug Eruption Reference Manual by Jerome Z. Litt. Participants taking medications with greater than 1% incidence of sun-related toxicities will not be included in the study.)

3. No history of having any abnormal responses to sunlight such as phototoxic or photoallergic responses.

4. No history of NMSC or melanoma.

5. The participant can understand and sign the consent form.

6. The test site for ssUVR exposure (buttocks) should be devoid of sunburn, suntan, scars, active dermal lesions, and uneven skin tones. The presence of nevi will be acceptable if in the physician's judgment they will not interfere with the study results. (Excess hair is acceptable if clipped or shaved.)

EXCLUSION CRITERIA

1. Participants will be excluded for the following reasons:

a. The participant does not meet the inclusion criteria.

b. The participant has a history of dysplastic nevi.

c. The participant has a history of allergic reactions to sunscreen or lidocaine.

d. The participant is taking immunosuppressing medications or is known to be immunosuppressed due to an underlying disease such as HIV, cancer, or post-organ transplantation.

e. The participant is pregnant or lactating.

f. The participant is unable to comply with the requirements of the protocol.

Special Instructions: Currently Not Provided

Keywords:

Skin Cancer

Genomics

Microarray

Sunscreen

UV

Recruitment Keywords:

Healthy Volunteer

HV

Conditions:

Healthy

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Matsumura Y, Ananthaswamy HN. Molecular mechanisms of photocarcinogenesis.

Front Biosci. 2002 Apr 1;7:d765-83. Review.

PMID: 11897559

Kraemer KH. Sunlight and skin cancer: another link revealed.

Proc Natl Acad Sci U S A. 1997 Jan 7;94(1):11-4. Review. No abstract available.

PMID: 8990152

Diffey BL, Farr PM. Sunscreen protection against UVB, UVA and blue light: an in vivo and in vitro comparison.

Br J Dermatol. 1991 Mar;124(3):258-63. Erratum in: Br J Dermatol 1991 Dec;125(6):609.

PMID: 1805808

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Bethesda, Maryland 20892. Last update: 10/15/2004