[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"skin-inflammation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:skin-inflammation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100619166","skin-inflammation-in-perimenopause-a-probiotic-intervention-proof-of-concept-trial-100619166",false,"NCT07341087","Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial","Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial (SIPPI)","SIPPI","Inclusion Criteria:\n\n1. Female, aged 40-60 years.\n2. Self-reported or clinician-diagnosed non-infectious, non-autoimmune inflammatory skin condition affecting the face (e.g., rosacea, acne, eczema).\n3. Willing and able to consume a daily oral intervention (2x 65 ml probiotic drinks or skimmed milk) for 8 weeks.\n4. Willing and able to provide sufficient blood, skin and stool samples at baseline and end-of-study (Week 8). Participants unable to provide adequate blood sample volumes will not be able to start the intervention.\n5. Willing and able to provide a photograph of the facial area, with all images anonymised for study purposes.\n6. Able to comply with study procedures, including attending clinic visits at KCL.\n7. Have access to a refrigerator at home and be able to store the study product(s) safely after collection (i.e., travel time allows safe storage).\n8. Capable of providing written informed consent.\n9. Have sufficient proficiency in English to complete study questionnaires and assessments.\n\nExclusion Criteria:\n\n1. Inability or unwillingness to provide informed consent.\n2. Inability or unwillingness to comply with study protocol requirements (e.g., clinic visits, sample provision, daily consumption of study drink)\n3. Unwilling to record dietary intakes using handwritten diet diaries\n4. Not fluent in the English language\n5. Is planning on international travel during the study period\n6. Current participation in another interventional clinical trial or having received an investigational\u002Fpharmaceutical product within the past 3 months.\n7. Known allergy or intolerance to dairy products, skimmed milk, or probiotic drinks containing Lactobacillus species.\n8. Currently pregnant, currently breastfeeding or planning to become pregnant in the next 4 months.\n9. BMI \\\u003C18.5kg\u002Fm2 or \\> 35kg\u002Fm2.\n10. Unintentional weight loss greater than 4 kg in the 3 months prior to enrolment.\n11. History of substance abuse or alcoholism (alcohol intake \\>50 units\u002Fweek) within the last 12 months.\n12. Current smokers, or individuals who quit smoking in the last 6-months.\n13. Fasting glucose \\>7mmol\u002Fl (finger prick test at baseline clinic).\n14. Active skin infection requiring systemic antibiotics, antivirals, or antifungals within the past 4 weeks.\n15. Major gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease, short bowel syndrome) or history of significant gastrointestinal surgery (excluding appendectomy or cholecystectomy).\n16. Known immunodeficiency (e.g., HIV, immunosuppressive therapy, systemic corticosteroids \\>10 mg\u002Fday prednisolone equivalent).\n17. History of malignancy or clinically significant non-malignant skin conditions within the past 5 years (except adequately treated basal cell carcinoma).\n18. Serious medical conditions that, in the opinion of the investigator, would compromise safety or interfere with study outcomes (e.g., uncontrolled diabetes, advanced cardiovascular, hepatic, or renal disease, active cancer, autoimmune conditions).\n19. Women with a history of severe psychiatric illness that would limit adherence to study requirements.\n20. Current use of probiotics, prebiotics, or antibiotics within 4 weeks prior to baseline.\n21. Current use of systemic corticosteroids, or other immunosuppressive\u002Fimmunomodulatory therapies within the past 3 months.\n22. Currently receiving, or having received, phototherapy (e.g., UVB, PUVA, laser\u002Flight-based treatments, including at home treatments) for any skin condition within the past 3 months.\n23. Currently receiving, or having received, systemic dermatology treatments likely to affect skin inflammation or immune response within the past 3 months (e.g., isotretinoin, methotrexate, cyclosporine, biologics such as TNF, IL-17, IL-23 or IL-4\u002FIL-13 inhibitors).\n24. Currently receiving, or having received, topical treatments likely to significantly alter skin inflammation within the past 3 months (e.g., high-potency topical corticosteroids, topical calcineurin inhibitors such as tacrolimus or pimecrolimus, topical retinoids, or photodynamic therapy).\n25. Currently using, or have used, probiotic skincare (e.g., topical creams and serums) within the past 3 months.\n26. Currently receiving, have undergone, or plan to undergo cosmetic skin procedures (e.g., chemical peels, laser therapy, dermal fillers, microneedling) within the 3 months prior to, or within 3 months after the first (baseline) visit.\n27. Currently using, or have used, hormonal contraceptives or treatments known to exacerbate skin conditions, including Mirena (levonorgestrel-releasing intrauterine system), oral progesterone-only contraceptives (e.g., mini-pill), and synthetic progestogens (e.g., norethisterone) within the past 3 months.","FEMALE","40 Years","60 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study will explore whether a daily probiotic drink containing Lactobacillus casei Shirota (LcS) can help improve immune function and reduce inflammation in women going through the menopausal transition. Hormonal changes during this stage of life can affect the immune system, gut health, and skin, sometimes leading to increased inflammation or conditions such as eczema, acne or rosacea.\n\nParticipants will consume either a low-sugar LcS probiotic drink or a skimmed milk control drink every day for eight weeks. The study will assess markers of immune ageing, inflammation, skin health, wellbeing, and hormone levels. The results will help determine whether a safe, non-hormonal probiotic approach may support immune and skin health during the menopausal transition.",[28,29,30,31,32,33,34,35],"Skin Inflammation","Immunosenescence","Inflammation","Skin Health","Eczema","Rosacea","Acne","Menopause",[37,38,39,40,41,42],"Probiotics","Lactobacillus casei Shirota","Immune ageing","Gut-skin axis","Skin health","Menopausal transition","RECRUITING","2026-05-05",{"date":46,"type":47},"2026-05-08","ACTUAL",{"date":49,"type":47},"2026-04-28",{"date":51,"type":22},"2027-11-01",{"name":53,"class":54},"King's College London","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":23,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":55},"100573774","phase-4-skin-barrier-function-and-inflammation-in-aging-the-bia-study-100573774","NCT06750653","Skin Barrier Function and Inflammation in Aging: The BIA Study","BIA","Inclusion Criteria\n\n1. Male or female ≥ 70 years of age at the baseline visit.\n2. Diagnosis of xerosis cutis based on an Overall Dry skin (ODS) score of =\\> 1 for any body site where patients will be asked to apply moisturizer (i.e. arms, legs, buttocks, front of trunk).\n3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative\n4. Ability for subject to comply with the requirements of the study.\n\nExclusion Criteria\n\n1. History of inflammatory skin disease (e.g. psoriasis, atopic dermatitis, or bullous pemphigoid) that has been active in the past 10 years.\n2. History of contact dermatitis to moisturizers.\n3. History of chronic inflammatory conditions (such as cancer, arthritis, inflammatory bowel disease, or coronary artery disease). Participants with a history of localized skin cancer will not be excluded.\n4. Current infection.\n5. Open skin wounds.\n6. Physical limitations or lack of a caregiver preventing application of a moisturizer to skin on the trunk and extremities.\n7. Current use of topical medications, oral systemic immunomodulatory treatments, or anti-microbial treatments.\n8. Diagnosis of primary or acquired immunodeficiency.\n9. Use of skin moisturizer less than 1 week prior to enrollment visit, with the exception that participants may use non-study moisturizer\u002Fsunscreen on face, if used consistently throughout study period.\n10. Inability to give informed consent.\n11. Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.\n12. If the participant does not meet all the above criteria, he\u002Fshe will not be eligible for study participation.",true,"ALL","70 Years",{"count":67,"type":22},32,[69],"PHASE4","This is a randomized, investigator-blinded, self-controlled pilot study of the physiologic response to topical moisturizers among older adults with dry skin. The overarching hypothesis is that skin barrier decline is an important source of chronic inflammation, and that skin barrier restoration with moisturizers can reduce serum biomarkers of inflammation. The primary objective is to determine the feasibility for a larger trial, and the secondary objectives are to determine the extent to which measures of serum inflammation, skin barrier function, and the skin microbiome change in response to moisturizers. Participants will be asked to apply one of two topical moisturizers that are widely available over the counter in the US (Vaseline® 100% pure petroleum jelly or CeraVe® moisturizing cream) once daily for 4 weeks to the front of the torso, buttocks, arms, and legs. Subjects will act as their own control (i.e. they will be asked to apply the study moisturizer they are randomized to for one intervention period (4 weeks) and not to apply topical moisturizers for the other 4- week intervention period). Participants will be randomized in a 1:1:1:1 ratio to one of 4 treatment groups: i. no intervention then CeraVe; ii. CeraVe then no intervention; iii. no intervention then Vaseline; iv. Vaseline then no intervention. At each visit (baseline, week 4, and week 8), participants will undergo skin barrier testing, skin microbiome sampling, and phlebotomy to measure serum inflammatory markers.",[30,28,72],"Aging",[74,75,72,30,76,77],"CeraVe","Vaseline","Skin","Older Adults","2026-03-04",{"date":80,"type":47},"2026-03-06",{"date":82,"type":47},"2025-02-06",{"date":84,"type":22},"2026-04-15",{"name":86,"class":54},"University of California, San Francisco"]