A Clinical Study to Evaluate the Interstitial Dermal Fluid, Efficacy and Sun Protection Factor (SPF) of Two Test Materials According to an Adaptation of the Guidelines of the FDA Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Chromameter
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Chromameter
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Thermometer reading(Right before and immediately after UV Exposure.)