Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer

Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836342
• Other study ID #: 2008-P-002240
• Status: Completed
• Phase: N/A
• First received: February 2, 2009
• Last updated: June 24, 2012
• Start date: February 2009
• Est. completion date: January 2012

Study information

• Verified date: June 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Skin Cancer
• Skin Neoplasms
• Squamous Cell Carcinoma

Locations

Country	Name	City	State
United States	Clinical Unit for Research Trials in Skin - MGH	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Nu Skin Enterprises

Country where clinical trial is conducted

United States, 

References & Publications (5)

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;(4):CD005414. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Nov 7. — View Citation

Santamaria L, Bianchi A. Cancer chemoprevention by supplemental carotenoids in animals and humans. Prev Med. 1989 Sep;18(5):603-23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects	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	No
Secondary	Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma		baseline	No
Secondary	Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group		baseline	No