| Eligibility |
Inclusion Criteria:
- Age: 18-70
- Sex: Male & Female
- Fitzpatrick: I-V, minimum 10% of panel Fitzpatrick V.
- Individuals who will be able to read, understand and give an informed consent relating
to the study they are participating in.
- Individuals who will be free of any dermatological or systemic disorder, which in the
Investigator's opinion, could interfere with the study results.
- Individuals who will be in general good health and who will complete a preliminary
medical history form mandated by the testing facility.
- Individuals who will be able to and agree to cooperate with the Investigator and
clinical staff.
- Individuals who will agree to have test products applied in accordance with the
protocol and are able to complete the full course of the study.
- Individuals who have not participated in a similar study in the past 30 days.
- Individuals who agree to refrain from sun tanning/bathing and prolonged exposure to
sunlight (outdoors).
- Individuals who are willing to refrain from wetting, wiping, cleanse, and covering the
test sites (volar surface of the forearms) between the baseline and up to 48-hour time
points.
- Female volunteers who are willing to undergo a urine pregnancy test.
- Individuals willing to refrain from vitamin C (Emergen-C), orange juice and vitamin
water for the study duration and two days prior to the SPT test.
Exclusion Criteria:
- Individuals who are currently taking any medications (topical or systemic) that may
mask or interfere with the test results (specifically, corticosteroids, topical and/or
systemic [except nasal steroids], non steroidal anti-inflammatory drugs [e.g.
ibuprofen, Advil, Motrin, aspirin > 325mg/day], antihistamines, and topical/oral
immunosuppressive medications).
- Individuals who have a history of any acute or chronic disease that might interfere
with or increase the risk on study participation. (e.g., systemic lupus erythematosus,
rheumatoid arthritis, HIV positive).
- Individuals who are diagnosed with chronic skin allergies (atopic dermatitis/eczema)
or recently treated skin cancer within the last 12 months.
- Individuals who have damaged skin in close proximity to test sites (e.g., sunburn,
uneven skin pigmentation, tattoos, scars, excessive hair, active acne papules or other
disfigurations).
- Individuals who control their diabetes using insulin.
- Individuals with any history, which in the Investigator's opinion, indicates the
potential for harm to the subject or places the validity of the study in jeopardy.
- Female volunteers who indicate that they are pregnant or are planning to become
pregnant or nursing.
- Individuals with a known history of hypersensitivity to any cosmetics, personal care
products, fragrances, and/or adhesives.
- Individuals that have a history of dermatographism.
- Individuals have a history of frequent skin irritation.
- Employees of ALS.
- Individuals with a known fish allergy.
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