Clinical trial NCT00836342: Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Cancer
Basal Cell Carcinoma
Squamous Cell Carcinoma
Keywords: Non-melanoma skin cancer
Basal cell carcinoma
Squamous cell carcinoma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Nu Skin Enterprises
First posted: 2009-02-04
Enrollment: 81
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The research population were recruited from Massachusetts General Hospital dermatology clinics.

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.

Eligibility 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.

Primary outcomes:
measure: Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects
timeFrame: baseline
Secondary outcomes:
measure: Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma
timeFrame: baseline
measure: Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group
timeFrame: baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Clinical Unit for Research Trials in Skin - MGH
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Alexandra B Kimball, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1016/j.ejca.2007.09.005. Epub 2007 Nov 7.
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. doi: 10.1001/archderm.136.2.179.
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. doi: 10.1364/ol.26.001179.