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Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer

This study has been completed.
Sponsor:
Collaborator:
Nu Skin Enterprises
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00836342
First received: February 2, 2009
Last updated: June 24, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition
Skin Cancer
Basal Cell Carcinoma
Squamous Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Skin Cancer
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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:
  • Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group [ Time Frame: baseline ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: February 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836342

Locations
United States, Massachusetts
Clinical Unit for Research Trials in Skin - MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Nu Skin Enterprises
Investigators
Principal Investigator: Alexandra B Kimball, MD, MPH Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00836342     History of Changes
Other Study ID Numbers: 2008-P-002240
Study First Received: February 2, 2009
Results First Received: May 14, 2012
Last Updated: June 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Non-melanoma skin cancer
Basal cell carcinoma
Squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Skin Neoplasms
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Skin Diseases
 Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013