[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aesthetic-improvement-of-the-skin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aesthetic-improvement-of-the-skin":28},{"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":13,"acronym":14,"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100625662","evaluation-of-quality-of-life-after-facial-hyaluroic-acid-injections-following-treatment-for-breast-cancer-100625662",false,"NCT07425548","Evaluation of Quality of Life After Facial Hyaluroic Acid Injections Following Treatment for Breast Cancer.","JOUVENCE","Inclusion Criteria:\n\n1. Women ≥ 18 years old and ≤ 50 years old.\n2. Non-menopausal status at time of diagnosis of breast cancer (self-reporting).\n3. Patient with breast cancer (uni or bilateral):\n\n   1. treated at the Institut Bergonié by chemotherapy (+\u002F- targeted\u002Fimmunotherapy) and surgical treatment (conservative or not) and\u002For hormone therapy and\u002For radiotherapy\n   2. who completed their treatment at least 6 months ago including end of treatment with Herceptin but with the exception for ongoing hormone therapy\n   3. in complete remission\n4. Non-immunosuppressed patient.\n5. Voluntarily signed and dated written informed consent prior to any study specific procedure.\n6. Patient affiliated to a social security in compliance with Article 1121-11 of the French Public Health Code.\n\nExclusion Criteria:\n\n1. Patients with a history of or declared autoimmune disease or immune system deficiency or undergoing immunosuppressive treatment. A 6-month washout is required.\n2. Patients undergoing or planning to undergo peeling treatment or laser\u002Fultrasound-based or botox treatment or hyaluronic acid injections during the study or having had one of these treatments in the 6 months preceding the study.\n3. Patients showing cutaneous disorders, inflammation or infection (acne, herpes labialis, scars…) at the treatment site or near to this site.\n4. Patients having a known hypersensibility to lidocaine and\u002For amide local anaesthetic agents or hyaluronic acid and\u002For proteins from gram-positive bacteria, or with a history of severe allergy or anaphylactic shock.\n5. Patients with a history of streptococcal disease (recurrent sore throat, rheumatic fever)\n6. Patients with autoimmune or cardiac diseases (i.e. heart conduction disorders) and\u002For undergoing treatment for heart diseases (beta-blockers).\n7. Patients with hepatocellular insufficiency and\u002For undergoing treatment for liver disease.\n8. Patients suffering from epilepsy not controlled by a treatment or porphyria.\n9. Patients with a tendency to develop hypertrophic scars.\n10. Patients with severe, ongoing and\u002For uncontrolled disease that may pose a health risk to the patient during the study and\u002For may have an impact on the study assessments.\n11. Patients receiving or planning to receive high dose Vitamin E, aspirin, anti-inflammatories, or anti-coagulant during the week preceding each injection\n12. Patients receiving any long-term medical treatment or any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the patient at undue risk.\n13. Patients under guardianship\u002Ftutorship.\n14. Pregnant women or breastfeeding mothers.","FEMALE","18 Years","50 Years",{"count":20,"type":21},22,"ESTIMATED","INTERVENTIONAL",[24],"NA","Breast cancer, the most common cancer in women, is increasingly managed as a chronic disease thanks to therapeutic advances. However, treatments such as chemotherapy and hormonotherapy often induce premature menopause in younger women, leading to skin aging, atrophy, and distressing symptoms that negatively affect quality of life. These cutaneous effects are frequently overlooked despite their psychological and social impact. Hyaluronic acid injections, already well established in aesthetic and reconstructive medicine, may offer a safe, minimally invasive option to restore skin quality, improve self-esteem, and enhance overall well-being in breast cancer survivors. This study aims to assess their efficacy and safety in this specific population.",[27,28],"Breast Cancer","Aesthetic Improvement of the Skin","NOT_YET_RECRUITING","2026-04-15",{"date":32,"type":33},"2026-04-16","ACTUAL",{"date":35,"type":21},"2026-04",{"date":37,"type":21},"2027-09",{"name":39,"class":40},"Institut Bergonié","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100604618","clinical-investigation-on-a-polynucleotide-based-device-used-to-improve-skin-hydration-100604618","NCT07151859","Clinical Investigation on a Polynucleotide-based Device Used to Improve Skin Hydration","A Pre-market, Two-stages, Monocentric, Interventional, Single-arm, Clinical Investigation to Evaluate the Safety and the Performance of PN30 (RDM16) for the Improvement of Skin Hydration","Inclusion Criteria:\n\n1. Subject Informed consent form (ICF) signed;\n2. Female and male Subjects aged 18-70 years;\n3. Subjects desiring improvement of skin hydration in maximum 1 area of the face or desiring improvement of skin hydration of neck or décolleté.\n4. Healthy skin;\n5. Willingness to discontinue all dermatological treatment and procedures during the study;\n6. Willingness to follow all study procedures, including attending all site visits, tests and examinations;\n7. Agreeing to present at each study visit without face\u002Fneck\u002Fdécolleté cosmetics;\n8. Accepting to not change their habits regarding food, physical activity, face\u002Fneck\u002Fdécolleté cosmetics and cleansing products;\n9. Willingness to follow indications to avoid make-up in the 12 hours following the injection treatment and to avoid any prolonged exposure to the sun, UV rays and temperatures below 0°C, as well as any sauna or hammam sessions at least until the wheals have been fully reabsorbed;\n10. Skin phototype I-IV according to Fitzpatrick's classification.\n\nExclusion Criteria:\n\n1. Other - different - clinical conditions of the skin (i.e. rosacea, psoriasis, vitiligo, active eczema, severe scleroderma, severe acne and diagnosticated cancer with\u002Fwithout ongoing antitumor therapy);\n2. Infectious or inflammatory processes near the area of intervention;\n3. Presence of cutaneous disease on the tested area, as malformations and recurrent facial\u002Flabial herpes;\n4. Presence of tendon, bone or muscular implants near the area of intervention;\n5. Ongoing cutaneous allergies;\n6. Allergy or contraindications to device components;\n7. Concomitant intake of anticoagulant or antiplatelet medications;\n8. Subjects who have not followed a washout period of 2 weeks from topical corticosteroids, antibiotics, benzoyl-peroxide, azelaic acid, hydroxy acids, topical retinoids;\n9. Immune system illnesses\u002Fdisease;\n10. Uncontrolled diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);\n11. Treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin E), or drugs able to influence the test results in the investigator opinion, within 5 days prior to study inclusion;\n12. Known drug and\u002For alcohol abuse;\n13. Mental incapacity that precludes adequate understanding or cooperation;\n14. Any previous permanent and non-permanent cutaneous treatment for aesthetic correction (biomaterial implant, lifting, laser, botulinum toxin injections, chemical peeling, fillers) of the treated area within 6 months prior to study inclusion;\n15. Pregnancy or breastfeeding;\n16. Participation in another investigational study within 1 month prior to study inclusion.",true,"ALL","70 Years",{"count":52,"type":21},43,[24],"Adequate skin hydration is critical for maintaining healthy skin. Moreover, dehydration, together with reduction in cell renewal, loss of radiance, elasticity and firmness, is involved in skin aging. Injectable anti-aging products have been widely used for aesthetic improvement of the skin.\n\nIn recent years, new filler products made from High Purification Technology Polynucleotides (PN HPTTM) have been developed and are now being used in Europe. PN HPTTM has a consolidated utilization in the aesthetic field and recently, specific guidelines in their utilization have been implemented. Polynucleotides (PNs) are polymeric chains formed by purines, pyrimidines, deoxyribonucleotides, and deoxyribonucleosides that can be found in cells throughout the human body. PNs have viscoelastic properties and the capability to bind, reorganize and orientate a high concentration of water molecules, creating 3D gel that undergoes an enzymatic cleavage.\n\nOn this basis, polynucleotide-containing products act as short-time temporary fillers to produce a volumizing effect and exert a lubricant and moisturizing action, due to the high concentration of water molecules. Moreover, they maintain for a long time the moisturizing and viscoelastic effect.\n\nA recent report which summarizes the findings and recommendations issued from the Italian Scientific Board of aesthetic physicians, supports the use of PN-HPT.\n\nIn this context, the Sponsor has developed PN30, a soft-tissue filler containing PN-HPT (at a concentration of 30 mg\u002F mL) as functional ingredients which help improve skin turgor and elasticity due to their moisturizing and viscoelastic properties.\n\nPN30 is a new device with no history of marketing but based on a similar product CE marked developed and sold by the Manufacturer with less amount of PN (2%). Therefore, the aim of this pre-market, twostages, monocentric, interventional, single-arm, clinical investigation is to evaluate the safety and the performance of PN30 (RDM16) for the improvement of skin hydration. The clinical investigation is planned as an adaptative two-stages study.\n\nThe planned procedures will be the same for both stages. The primary objective\u002Fendpoint of STAGE I will be to evaluate the safety, while the primary objective\u002Fendpoint of STAGE II will be to evaluate the performance of the device.",[28,56,57,58,59],"Skin Hydration in Healthy Volunteers","Skin Elasticity","Skin Turgor","Subject Satisfaction",[61,62,63,64,65,66,67,68,69,70,71],"aesthetic","Polynucleotides","PN HPT","skin","skin quality","skin elasticity","skin turgor","skin hydration","face","neck","décolleté","RECRUITING","2026-01-30",{"date":75,"type":33},"2026-02-03",{"date":77,"type":33},"2025-09-18",{"date":79,"type":21},"2027-03-31",{"name":81,"class":82},"Mastelli S.r.l","INDUSTRY",1]