[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Good Molecules, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100655531","phase-4-a-clinical-investigation-of-a-topical-moisturizer-on-skin-barrier-function-in-adults-with-sensitive-skin-100655531",false,"NCT07811531","A Clinical Investigation of a Topical Moisturizer on Skin Barrier Function in Adults With Sensitive Skin","An Exploratory Clinical Investigation of a Topical Moisturizer on Skin Barrier Function, Inflammatory Biomarkers, and Skin Microbiome in Adults With Sensitive Skin","Inclusion Criteria:\n\n* Adults aged 18 to 55 years, inclusive, of any sex.\n* Self-declared sensitive skin affecting the body, characterized by unpleasant sensations such as burning, stinging, itching, tingling, tightness, or irritation in response to products or environmental triggers.\n* Must present a TEWL value ≥15 g\u002Fm2\u002Fh on a volar forearm at the screening visit (T-7).\n* Approximately 40-60% of enrolled participants should have Fitzpatrick skin types I-III, and approximately 40-60% should have Fitzpatrick skin types IV-VI.\n* Must agree to complete a minimum 7-day washout period prior to baseline.\n* Must agree to avoid body skincare products, moisturizers, hydrating gels, or prohibited topical products on both forearms during washout.\n* Must agree to use sponsor-provided SPF 30 sunscreen on both forearms beginning at least 7 days before baseline and continuing throughout study participation.\n* Must be willing and able to comply with all study requirements, including clinic visits, product use, questionnaires, and sample collection procedures.\n* Must provide written informed consent prior to any study-specific procedure.\n* Must be willing to apply study products twice daily (morning and evening) for 28 consecutive days and maintain diary compliance.\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, or planning pregnancy during the study.\n* Active dermatologic disease on the forearms, visible scars, or tattoos that interfere with measurement.\n* History of chronic inflammatory or autoimmune conditions (rheumatoid arthritis, lupus, psoriasis, IBD, ankylosing spondylitis, multiple sclerosis).\n* Active cancer or cancer treatment within the past 5 years, with the exception of localized non-melanoma skin cancer.\n* Diagnosis of primary or acquired immunodeficiency.\n* Use of systemic corticosteroids (oral or injected) within 4 weeks pre-enrollment, or anticipated use during the study.\n* Use of biologics for inflammatory conditions within 12 weeks pre-enrollment (including TNF inhibitors, IL-17 inhibitors, IL-23 inhibitors, IL-4\u002FIL-13 inhibitors, dupilumab, lebrikizumab, tralokinumab, JAK inhibitors, and IL-1 blockers).\n* Use of systemic immunosuppressants within 8 weeks pre-enrollment (methotrexate, cyclosporine, mycophenolate, azathioprine, systemic tacrolimus).\n* Use of systemic antibiotics within 4 weeks pre-enrollment, or anticipated use during the study.\n* Regular use of oral NSAIDs (defined as more than 2 days per week on average) within 2 weeks pre-enrollment or anticipated regular use during the study. Occasional use for acute conditions is permitted with logging.\n* Daily aspirin use, including low-dose aspirin for cardiovascular prophylaxis.\n* Use of topical corticosteroids, calcineurin inhibitors, or other prescription anti- inflammatory topicals on the forearms within 4 weeks pre-enrollment.\n* Use of topical retinoids, alpha hydroxy acids, beta hydroxy acids, or other active exfoliants on the forearms within 4 weeks pre-enrollment.\n* Active smoking (including vaping and recent cessation within 6 months).\n* Heavy alcohol use, defined as more than 8 drinks per week.\n* Surgery under general anaesthesia within the past 4 weeks.\n* Vaccination within 2 weeks pre-enrollment.\n* Excessive UV exposure (sunbathing, tanning beds) within 4 weeks pre-enrollment.\n* Enrolled in another clinical trial within the 4 weeks pre-enrollment or during the study period.","ALL","18 Years","55 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The purpose of this research study is to evaluate whether a marketed moisturizing cream can improve skin barrier function (how well the outer layer of the skin keeps moisture in and protects the skin), skin hydration, skin sensitivity, inflammatory biomarkers (proteins in the skin that can provide information about inflammation), and the skin microbiome (the microorganisms that naturally live on the skin) in adults with sensitive skin, when compared with a commonly used moisturizing ointment (White Petrolatum) a widely used occlusive ointment (an ointment that forms a protective layer over the skin to help reduce moisture loss).",[27],"Sensitive Skin","RECRUITING","2026-09-04",{"date":31,"type":32},"2026-09-10","ACTUAL",{"date":34,"type":21},"2026-09-14",{"date":36,"type":21},"2027-01-12",{"name":38,"class":39},"Good Molecules, LLC","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":40},"100653714","phase-4-a-clinical-study-to-evaluate-the-efficacy-and-spf-of-two-test-materials-according-to-an-adaptation-of-the-guidelines-of-the-fda-sunscreen-drug-products-for-over-the-counter-human-use-100653714","NCT07789639","A Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use","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","Inclusion Criteria:\n\n* 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\n* 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\n* Subject agrees to undergo the micro needling procedure on their back (a total of 5 sites)\n* Subject should not have their back shaved or waxed 3 days prior to the start of the study\n* Subject is able to read, write, speak, and understand English\n* Subject is in good general health\n* Subject agrees to avoid UV exposure to the test area for the duration of the study\n* Subject is willing to wear loose-fitting clothing that exposes mid to lower back for study visits\n* Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits\n* Subject is willing to participate in all study evaluations and follow all instructions\n* Subject has a current Subject Profile Form on file at ECRL\n* Subject has uniform skin color over the test area; ITA° calculation range ≤10-point difference (example: 35.6°-45.6°)\n* Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study\n* Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164\n\nExclusion Criteria:\n\n* Female subject is pregnant, nursing, planning a pregnancy, or using inadequate birth control\n* Subject has a history of abnormal response to sunlight\u002FUV radiation; sensitivity to any ingredient of the test materials, standard or latex; or any known allergies to sunscreen, cosmetic, and\u002For toiletry products\n* 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\n* Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and\u002For systemic or topical corticosteroids within one week prior to initiation of the study.\n* Subject has used a prohibited medication (per separately provided prohibited medication list) within the specified timeframes prior to initiation of the study\n* Subject has used\u002Fapplied any personal care products (e.g. lotions, sunscreens, sunless tanners) and\u002For topical medications in\u002Fon the testing area (the back between the shoulder blades and the waist line) within 24 hours prior to Day 1 or during the study\n* Subject has any known communicable disease(s) (e.g. HIV, STD's, Hepatitis B, Hepatitis C, etc.)\n* Subject has any skeletal protrusions and\u002For extreme areas of curvature in the test area\n* Subject with medical treatment\u002Fvaccination 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.\n* Subject has undergone any surgical procedure in the last 12 months\n* Subject has undergone chemical or physical treatment procedures in the test area within the last 12 months\n* Subject is planning hospitalization during the study\n* Subject exceeds the weight limit of 300 pounds due to equipment limitations\n* Subject has any condition that might confound the study results, increase the risk associated with participation, or interfere with study participation;\n* Subject has any visible sunburn or suntan in testing area\n* Subject has used an artificial tanning lamp or had recent sun exposure to the test area within the past 2 months\n* 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).",true,"75 Years",{"count":51,"type":21},60,[24],"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).",[55,56],"Epidermis","Ultraviolet Exposure",[58,59,60],"SPF","Ultraviolet Radiation","Erythema","2026-08-24",{"date":63,"type":32},"2026-08-27",{"date":34,"type":21},{"date":66,"type":21},"2027-04-07",{"name":38,"class":39},""]