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

NCT00099112 | Completed

• 2 other identifiers: CDR0000357437NCI-04-C-0120
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-melanomatous Skin Cancer; Precancerous Condition

Keywords

basal cell carcinoma of the skin; squamous cell carcinoma of the skin; actinic keratosis

Interventions

microarray analysis GENETIC

biopsy PROCEDURE

evaluation of cancer risk factors PROCEDURE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Precancerous Conditions; Carcinoma, Basal Cell; Keratosis, Actinic

Interventions

Microarray Analysis; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical Procedures; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Jonathan C. Vogel, MD

  NCI - Dermatology Branch

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 8, 2004
• First Posted: December 9, 2004
• Study Start: February 1, 2004
• Last Updated: April 30, 2015

Record last verified: 2005-11

Locations

US (1)