Basal Cell Carcinoma, Skin Cancer, Squamous Cell Carcinoma
Conditions
Keywords
Non-melanoma skin cancer, Basal cell carcinoma, Squamous cell carcinoma
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.
Interventions
None listed
Sponsors
Nu Skin Enterprises
Massachusetts General Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma | baseline |
| Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group | baseline |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from May 2009 to December 2011. Subjects were recruited from dermatology medical and surgery clinics at the Massachusetts General Hospital.
Pre-assignment details
Patients were enrolled in the study if they had a history of cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma but were excluded if they had a history of both basal cell carcinoma and squamous cell carcinoma. Participants were also excluded if they were using retinoids or taking a multivitamin regularly for less than 5 yrs.
Participants by arm
| Arm | Count |
|---|---|
| Previous History of SCC Participants had previous history of squamous cell carcinoma | 22 |
| Previous History of BCC Participants had previous history of basal cell carcinoma | 23 |
| Control Group Participants had no history of squamous cell carcinoma or basal cell carcinoma | 36 |
| Total | 81 |
Baseline characteristics
| Characteristic | Previous History of SCC | Previous History of BCC | Control Group | Total |
|---|---|---|---|---|
| Age Continuous Mean age | 63.9 years | 60.9 years | 57.4 years | 60.2 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 23 Participants | 31 Participants | 76 Participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 30 Participants | 55 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 6 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 23 | 0 / 36 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 | 0 / 36 |
Outcome results
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.
Time frame: baseline
Population: Participants that passed inclusion criteria and consented for skin carotenoid measurement were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Previous History of SCC | Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects | 27,635 Raman spectroscopy intensity counts |
| Control Group | Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects | 31,219 Raman spectroscopy intensity counts |
Comparison: Null hypothesis: There is no difference in mean carotenoid levels between subjects with a history of squamous cell carcinom and control subjects.p-value: 0.31t-test, 2 sided
Secondary
Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Previous History of SCC | Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group | 25,031 Raman spectrocopy intensity counts |
| Control Group | Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group | 31,219 Raman spectrocopy intensity counts |
p-value: 0.09t-test, 2 sided
Secondary
Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Previous History of SCC | Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma | 27,635 Raman spectroscopy intensity counts |
| Control Group | Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma | 25,031 Raman spectroscopy intensity counts |
p-value: 0.49t-test, 2 sided