Phase
Condition
Skin Wounds
Rash
Hives (Urticaria)
Treatment
Active product
Placebo
Clinical Study ID
Ages 21-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Caucasian volunteers aged between 21 and 65 years at the time of the signature ofInformed consent form (ICF),
Signed Informed consent form (ICF),
Fitzpatrick skin phototypes I-III,
No skin pigmentation disorders,
In good health condition,
Willingness to avoid a consumption of any food supplements containing red orangeextract, polypodium extract, carotenes or other antioxidants that could interferewith the results during the study,
Willingness to avoid the sun, tanning beds and tanning products on the test areaduring the study,
Willingness to follow all study procedures and keeping a diary during the study (tofollow their compliance and palatability),
No changes in dietary habits or dietary supplements in last 2 months prior toinclusion.
No changes in cosmetic body care routine in last month prior to inclusion onmeasurement areas.
No recent participation in any other similar study.
No sun exposure (both natural and artificial) for at least two months before studystart on the test area.
Absence of sunburn, suntan, scars, or other active dermal lesions on the test area.
Colour uniformity of the test area (without tattoo, nevi, blemishes or solar lentigoand without hair).
Exclusion
Exclusion Criteria:
Pregnancy or breastfeeding or planning pregnancy in next 6 months (for women)
Known or suspected allergy to any ingredient of the tested products or UV radiation.
Dermatological problems in the test area or the requirement for annual mole checksby a dermatologist.
Pharmacological treatments (both locally or systemically) that could interfere withthe results.
Positive anamnesis for atopy (allergic hypersensitivity affecting parts of the bodynot in direct contact with the allergen)
Use of self-tanning products for at least 2 months before study start.
Medication with photosensitizing potential, drugs, corticoids in last month prior tostudy start.
Regular consumption of food supplements containing red orange extract, polypodiumextract, carotenoids or other antioxidants or supplements able to induce skin colourin last month before inclusion into the study.
Any clinically significant history of melanoma or skin cancer (including theirimmediate family), serious metabolic disease, digestive tract disease, liverdisease, kidney disease, haematological disease or other illness that couldinterfere with the study.
History of severe reactions from exposure to sunlight (i.e., polymorphous lighteruption)
Any surgery, chemical or physical treatment on the experimental area within the 12months prior to the study or foreseeing it for the duration of the study.
Regular depilation of test area.
Planning a hospitalization during the study.
Impaired immune system due to autoimmune diseases, or use of immunosuppressivemedication.
Mental incapacity that precludes adequate understanding or cooperation.
Study Design
Study Description
Connect with a study center
VIST - Faculty of Applied Sciences, Institute of Cosmetics
Ljubljana, 1000
SloveniaSite Not Available
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