Epidermis, Ultraviolet Exposure
Conditions
Keywords
SPF, Ultraviolet Radiation, Erythema
Brief summary
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).
Interventions
DRUGHybrid sunscreen
Hybrid D II SPF 30
DRUGChemical sunscreen
Chemical SPF 30
OTHERNo sunscreen
No SPF Placebo
Sponsors
Good Molecules, LLC
Eurofins CRL Cosmetics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * Subject is able to read, write, speak, and understand English * Subject is in good general health * Subject agrees to avoid UV exposure to the test area for the duration of the study * Subject is willing to wear loose-fitting clothing that exposes mid to lower back for study visits * Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits * Subject is willing to participate in all study evaluations and follow all instructions * Subject has a current Subject Profile Form on file at ECRL * Subject has uniform skin color over the test area; ITA° calculation range ≤10-point difference (example: 35.6°-45.6°) * Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study * Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164
Exclusion criteria
* 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. * Subject has used a prohibited medication (per separately provided prohibited medication list) within the specified timeframes prior to initiation of the study * Subject has used/applied any personal care products (e.g. lotions, sunscreens, sunless tanners) and/or topical medications in/on the testing area (the back between the shoulder blades and the waist line) within 24 hours prior to Day 1 or during the study * Subject has any known communicable disease(s) (e.g. HIV, STD's, Hepatitis B, Hepatitis C, etc.) * Subject has any skeletal protrusions and/or extreme areas of curvature in the test area * Subject with medical treatment/vaccination planned during the study, which would make the subject ineligible, place the subject at undue risk, or confound the outcome of the study, per the discretion of the PI. * Subject has undergone any surgical procedure in the last 12 months * Subject has undergone chemical or physical treatment procedures in the test area within the last 12 months * Subject is planning hospitalization during the study * Subject exceeds the weight limit of 300 pounds due to equipment limitations * Subject has any condition that might confound the study results, increase the risk associated with participation, or interfere with study participation; * Subject has any visible sunburn or suntan in testing area * Subject has used an artificial tanning lamp or had recent sun exposure to the test area within the past 2 months * Subject has participated in another UV exposure clinical study in the last 2 months, or is currently enrolled in a clinical study utilizing the same test site (i.e., no back patches during a UV exposure study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chromameter | Chromameter measurements will be obtained at Day 1 Baseline and Day 3 post treatment | 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 | Baseline and Day 3 Post-treatment | 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 | Baseline and Day 3 Post-treatment | 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 | Baseline and Day 3 Post-treatment | 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. |
| Dermal interstitial fluid | At the Baseline timepoint, a sub-site to the top left of the testing area will be used for the micro-needling. | Client-provided human interstitial fluid samples and commercially-sourced artificial interstitial fluid will be evaluated at multiple dilutions for levels of IL-1α, IL-6, IL-8, and VEGF-A using Luminex methodology (Thermo Fisher ProcartaPlex catalog #PPXT-04). Two (2) client-provided human interstitial fluid samples will be evaluated at 8 dilutions in singlicate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thermometer reading | Right before and immediately after UV Exposure. | 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. |
Countries
United States
Contacts
CONTACTAlexis Chantal, PA-C
Outcome results
None listed