| Eligibility |
Inclusion Criteria:
- Healthy individuals 18 years of age or older.
- Individuals with mild, moderate, or severe photodamage [1] of the skin on the forearms
(also Appendix C) and Fitzpatrick skin type II or III (21 CFR 352.72).
- Females of childbearing potential will need to undergo a pregnancy test at the
enrollment visit, after administration of the ICF and before exposure to SSL.
Premenopausal female subjects must use an effective method of birth control (such as
oral contraceptives, consistent use of barrier contraceptives, IUD, or other proven
method of birth control) during study participation. For the purposes of this study, a
woman will be considered postmenopausal if any of the following criteria are met: (1)
she has had prior bilateral oophorectomy; (2) she is over the age of 60 years; or (3)
she is under the age of 60 years and has not had a menstrual period in 12 or more
months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression.
- Individuals who are willing to limit sun exposure to the body during the study period
and who agree to wear protective clothing when they are outdoors.
- Individuals who have the ability to understand and willingness to sign an informed
consent before initiation of study procedures, after the nature of the study is
explained to them and they have had the opportunity to ask any questions.
Exclusion Criteria:
- Individuals with any inflammation or irritation of the skin at the test areas, or any
skin conditions felt by the study medical provider to contraindicate enrollment. This
includes, but is not limited to, psoriasis or atopic dermatitis within the test areas.
- Test area is defined as the 6 mm areas of skin that is exposed to SSL and will be
biopsied.
- Individuals with a history of any untreated skin cancer, melanocytic lesions, or
actinic keratoses in the test areas are ineligible. History of such conditions at a
body site other than the test areas is not exclusionary if in the opinion of the study
medical provider it will not pose a risk to the subject.
- Individuals who have had invasive cancer, chemotherapy or radiation therapy within
five years of study enrollment
- Individuals who are immunosuppressed by virtue of medication or disease. This includes
AIDS patients, subjects taking oral steroids, and subjects on
immunosuppressants/immunomodulators (cyclosporine, chemotherapeutic agents, or
biologic therapy), as determined by the examining study medical provider.
- Individuals with serious intercurrent illness including, but not limited to, ongoing
or active infection, psychiatric illness, or other situations that in the opinion of
the examining study medical provider would limit compliance or interfere with the
study regimen.
- Individuals who have used photosensitizing drugs (see Appendix for examples) within 30
days of enrollment, or who will be using a photosensitizing drug during the time of
the study, will not be eligible. Subjects may be reconsidered for eligibility 30 days
after the last dose of such medications.
- Individuals who have used any topical medication other than emollients or
sunscreen/sunblock on the test area within 30 days prior to study enrollment. If a
study participant requires topical medication to the test area during the study, they
will be withdrawn from the study.
- Individuals who have used retinoids, steroids, 5-fluorouracil, Levulan, Vaniqua
(eflornithine), Solaraze, or Imiquimod (Aldara®) anywhere on the body within 30 days
prior to study enrollment. Subjects may be reconsidered for eligibility 30 days after
the last topical treatment with such medications.
- Individuals must not take mega-doses of vitamins. Mega-doses are defined as more than
5 capsules of standard multivitamins daily or more than the Tolerable Upper Intake
Levels of Vitamins, as defined by the Institute of Medicine, National Academy of
Sciences. Such vitamin therapy must be discontinued at least 30 days prior to study
entry.
- Individuals with a history of deliberate natural or artificial sun exposure (tanning)
within 30 days of study enrollment are not eligible.
- Individuals with Fitzpatrick skin type I are ineligible, as the proposed SSL dose
could result in a burn of greater than mild severity.
- Individuals with Fitzpatrick skin type IV, V or VI are ineligible, as they are
unlikely to exhibit a salient response in the proposed design.
- Individuals currently enrolled in or who plan to enroll in another clinical trial.
There must be a 30-day period between completing a previous study and enrolling in
this study.
- Individuals with a known allergy to lidocaine are not eligible.
- Females who are pregnant or nursing.
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