Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer

Completed

• Conditions: Skin Cancer; Basal Cell Carcinoma; Squamous Cell Carcinoma

• Registration Number: NCT00836342
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this study is to determine the difference of skin carotenoid levels between subjects with previous squamous cell carcinomas (SCC), subjects with previous basal cell carcinomas (BCC) and a control group.

Detailed Description

There has been experimental and clinical research evaluating association of different carotenoids and incidence of malignancies, including Non- Melanoma Skin Cancer (NMSC). An easy and inexpensive way to determine which subjects would benefit from supplementation with carotenoids or retinoids could be the measurement of skin carotenoid levels.The least invasive way to perform it is through Raman spectroscopy which is a technique that uses a laser light that can be used to quantify carotenoids on the skin. We will compare the skin carotenoid levels of subjects with previous history of SCC or BCC and subjects without history of previous NMSC.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-04
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2012-05-14
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-24
• Last Update Submitted: 2012-06-24
• Results First Posted: 2012-07-25
• Last Update Posted: 2012-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Subjects between 50 and 75 years old without history of previous SCC or BCC.
• Fitzpatrick skin types I-IV.
• Willing and able to understand and sign informed consent.
• Able to complete study and comply with study procedures

Exclusion Criteria

• Regular ingestion of supplements containing carotenoids or vitamin A in the past 4 weeks.
• Use of topical retinoids in the past 4 weeks.
• Treatment with systemic retinoids in the past 6 months.
• Dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, palmar psoriasis, hand dermatitis or palmo-plantar keratoderma.
• Previous history of psoriasis.
• Clinically significant abnormal findings or conditions, which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
• Subjects who are known to be pregnant or planning a pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects	baseline	Mean carotenoid levels in subjects with a history of squamous cell carcinoma were compared to mean carotenoid levels in control subjects without a history of nonmelanoma skin cancer.

Secondary Outcome Measures

Name	Time	Method
Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma	baseline
Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group	baseline

Trial Locations

Locations (1)

Clinical Unit for Research Trials in Skin - MGH; 🇺🇸 Boston, Massachusetts, United States