Phase
Condition
Allergy (Pediatric)
Allergy
Allergies & Asthma
Treatment
ColActivePlus Collagen Matrix Dressing
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 consentrelating to the study they are participating in.
Individuals who will be free of any dermatological or systemic disorder, which inthe Investigator's opinion, could interfere with the study results.
Individuals who will be in general good health and who will complete a preliminarymedical history form mandated by the testing facility.
Individuals who will be able to and agree to cooperate with the Investigator andclinical staff.
Individuals who will agree to have test products applied in accordance with theprotocol 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 tosunlight (outdoors).
Individuals who are willing to refrain from wetting, wiping, cleanse, and coveringthe 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 vitaminwater for the study duration and two days prior to the SPT test.
Exclusion
Exclusion Criteria:
Individuals who are currently taking any medications (topical or systemic) that maymask or interfere with the test results (specifically, corticosteroids, topicaland/or systemic [except nasal steroids], non steroidal anti-inflammatory drugs [e.g.ibuprofen, Advil, Motrin, aspirin > 325mg/day], antihistamines, and topical/oralimmunosuppressive medications).
Individuals who have a history of any acute or chronic disease that might interferewith or increase the risk on study participation. (e.g., systemic lupuserythematosus, 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 orother disfigurations).
Individuals who control their diabetes using insulin.
Individuals with any history, which in the Investigator's opinion, indicates thepotential 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 becomepregnant or nursing.
Individuals with a known history of hypersensitivity to any cosmetics, personal careproducts, 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.
Study Design
Study Description
Connect with a study center
ALS Beauty and Personal Care
Torrance, California 90501
United StatesSite Not Available
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