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Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer

NCT ID: NCT00836342

Last Updated: 2012-07-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Skin Cancer Basal Cell Carcinoma Squamous Cell Carcinoma

Keywords

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Non-melanoma skin cancer Basal cell carcinoma Squamous cell carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Previous history of SCC

Participants had previous history of SCC

No interventions assigned to this group

Previous history of BCC

Participants had previous history of BCC

No interventions assigned to this group

Control

Participants had no previous history of squamous cell carcinoma or basal cell carcinoma

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nu Skin Enterprises

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alexandra Kimball

Director, Clinical Unit for Research Trials in Skin

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandra B Kimball, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Clinical Unit for Research Trials in Skin - MGH

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Bath-Hextall F, Leonardi-Bee J, Somchand N, Webster A, Delitt J, Perkins W. Interventions for preventing non-melanoma skin cancers in high-risk groups. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD005414. doi: 10.1002/14651858.CD005414.pub2.

Reference Type BACKGROUND
PMID: 17943854 (View on PubMed)

Santamaria L, Bianchi A. Cancer chemoprevention by supplemental carotenoids in animals and humans. Prev Med. 1989 Sep;18(5):603-23. doi: 10.1016/0091-7435(89)90033-9.

Reference Type BACKGROUND
PMID: 2694158 (View on PubMed)

Heinen MM, Hughes MC, Ibiebele TI, Marks GC, Green AC, van der Pols JC. Intake of antioxidant nutrients and the risk of skin cancer. Eur J Cancer. 2007 Dec;43(18):2707-16. doi: 10.1016/j.ejca.2007.09.005. Epub 2007 Nov 7.

Reference Type BACKGROUND
PMID: 17988857 (View on PubMed)

Frieling UM, Schaumberg DA, Kupper TS, Muntwyler J, Hennekens CH. A randomized, 12-year primary-prevention trial of beta carotene supplementation for nonmelanoma skin cancer in the physician's health study. Arch Dermatol. 2000 Feb;136(2):179-84. doi: 10.1001/archderm.136.2.179.

Reference Type BACKGROUND
PMID: 10677093 (View on PubMed)

Ermakov IV, Ermakova MR, McClane RW, Gellermann W. Resonance Raman detection of carotenoid antioxidants in living human tissues. Opt Lett. 2001 Aug 1;26(15):1179-81. doi: 10.1364/ol.26.001179.

Reference Type BACKGROUND
PMID: 18049555 (View on PubMed)

Other Identifiers

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2008-P-002240

Identifier Type: -

Identifier Source: org_study_id