Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer

June 24, 2012 updated by: Alexandra Kimball, Massachusetts General Hospital

Comparison of Skin Carotenoid Levels Between Subjects With History of Cutaneous Squamous Cell Carcinoma and Subjects With History of Basal Cell Carcinoma Versus a Control Group

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Clinical Unit for Research Trials in Skin - MGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The research population were recruited from Massachusetts General Hospital dermatology clinics.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Previous history of SCC
Participants had previous history of SCC
Previous history of BCC
Participants had previous history of BCC
Control
Participants had no previous history of squamous cell carcinoma or basal cell carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects
Time Frame: 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.
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma
Time Frame: baseline
baseline
Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Nu Skin Enterprises

Investigators

  • Principal Investigator: Alexandra B Kimball, MD, MPH, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 2, 2009

First Submitted That Met QC Criteria

February 2, 2009

First Posted (Estimate)

February 4, 2009

Study Record Updates

Last Update Posted (Estimate)

July 25, 2012

Last Update Submitted That Met QC Criteria

June 24, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-P-002240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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