Approximately 70 subjects (35 subjects per light and dark group) will be enrolled in this clinical study (to complete with a minimum of 10 subjects per skin type (I-VI) to assess the effects of known UV Radiation dosage on light and dark skin, assess the protective effect of two SPF test materials, placebo product, and standard sunscreen ('Pad O') on skin, before and after a known UV Radiation dosage and collect the interstitial dermal fluid from approximately 60 subjects and send to Eurofins Discovery for analysis. The following study evaluations will be obtained: SPF Determination, Visual Assessment of Erythema, Chromameter and Mexameter measurements, Digital photography, Thermometer readings and Collection of Dermal Interstitial Fluid (IDF).
Subject is male or female between 18 - 75 years old, providing legally effective, written informed consent in conformance with 45 CFR Parts 160 and 164
Subject has a Fitzpatrick Skin Type of I, II, or III, Light Skin Group or IV, V, or VI Dark Skin Group with an approximately equal distribution of all skin types (approximately 10 of each Fitzpatrick skin type) within each group as determined by ITA Angle
Subject agrees to undergo the micro needling procedure on their back (a total of 5 sites)
Subject should not have their back shaved or waxed 3 days prior to the start of the study
Female subject is pregnant, nursing, planning a pregnancy, or using inadequate birth control
Subject has a history of abnormal response to sunlight/UV radiation; sensitivity to any ingredient of the test materials, standard or latex; or any known allergies to sunscreen, cosmetic, and/or toiletry products
Subject has a history of or any current significant dermatological condition, such as atopic dermatitis (eczema), psoriasis, skin cancer, melanoma, active dermal lesions, nevi, keloids blemishes, abnormal scarring or moles, lupus, diabetes, or connective tissue disease that would increase the risk associated with participation
Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study.
Single group
Hybrid sunscreen
DrugHybrid D II SPF 30
Chemical sunscreen
DrugChemical SPF 30
No sunscreen
Other interventionNo SPF Placebo
Chromameter
This study will use a reflectance colorimeter, CM-700d (Konica Minolta) or equivalent, a handheld device that measures skin color in the L\*a\*b\* color space. The L\*, a\*, and b\* values will be measured from at least 3 different locations on the subject's back and then used to calculate the ITA°, which can be used to estimate a subject's MEDu
Dermal Darkening Evaluation
A technician will determine post UV dose immediate responses using the assessment scale listed below: Table 4. Immediate Response Codes N No Immediate response D Immediate Darkening R Immediate Reddening H Immediate Generalized Heat Response Spreading Beyond the Subsite
Erythema Dermal Evaluation
Table 5. Grading Scale for Erythema Responses to UV Doses Administered to Untreated Sites and Sunscreen-Treated Sites 0 = No erythema response or inconclusive response 0.5 = Ambiguous erythema and/or no clear border and/or not filling more than 50% of the exposure subsite. (Minimally perceptible erythema) 1. = Perceptible unambiguous erythema with clearly defined borders (filling more than 50% of the exposure subsite) 2. = Moderate to intense erythema
Mexameter
Three Mexameter measurements will be obtained from the subjects randomized test sites on the back at each designated time point to assess erythema and melanin.
Thermometer reading
A Fisher brand IR Thermometer will be used to obtain the subjects skin temperature from the following test sites: Untreated area, and for the areas treated with No SPF Placebo, Hybrid SPF 30, and Chemical Benchmark SPF 30 before and after UV Exposure.
Click on the lead sponsor to view all of their trials.
Good Molecules, LLC
Lead sponsor
Eurofins CRL Cosmetics, Inc.
Collaborator
