A Prospective, Open, Multicenter Clinical Study Over 48 Weeks to Investigate Efficacy and Safety of Cell-free Autologous Conditioned Serum (ACS) in Patients with Skin Elasticity Loss - Exokine

niversita¨t Hamburg Fachrichtung Kosmetikwissenschaft0 个研究点目标入组 95 人开始时间: 2019年1月24日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Confirmed skin elasticity loss: Cutometer R0 value = 0,31;
•2. Female aged 30-65 years;
•3. Patients accept not to alter their usual skincare routine during the study;
•4. Botulinumtoxin: no treatments 6 months before enrolment in the study. Patients accept not to start with treatment during the study;
•5. Hyaluronic acid (HA): no treatments with low-viscoelastic HA in the last 12 months. Patients accept not to start with any HA treatment during the study;
•6. Hyaluronic acid (HA): no treatments with high-viscoelastic HA in the last 24 months. Patients accept not to start with any HA treatment during the study;
•7. Skin booster and laser: no treatments in the past and during the study;
•8. Corneometer (Hydration) measurements: Patients accept not to wash their face and not to treat with any products minimum 6 hours before measurements are performed on the study visit days;
•9. Provision of signed and dated informed consent form to participate in the study.

•1. Infectious diseases, which are transmissible through blood such as HIV, HBV and HCV, any acute infections (confirmed with high CRP);
•2. Severe skin diseases e.g. psoriasis, atopic eczema (neurodermatitis), acne, active herpes zoster or other autoimmune skin diseases in the face;
•3. Skin cancer in the anamnesis;
•4. Treatment with chemotherapy, immunosuppressive agents or immunomodulatory therapy (e.g. corticosteroids, monoclonal antibodies) within 3 months before study treatment;
•5. Systemic diseases with skin involvement (e.g.SLE);
•6. Severe diet in the last 3 months before study treatment or the intention to start such while participating in the study;
•7. Taking nutritional supplementary in the last 3 months or the intention to take them while participating in the study;
•8. Pregnancy or woman who plan to become pregnant during the course of the study;
•9. History of bleeding disorders;
•10. Treatment with anticoagulants or inhibitors of platelet aggregation (e.g. ASS or other non-steroidal anti-inflammatory drugs [NSAIDs]);
•11. Tendency to form keloids, hypertrophic scars or other healing disorder;
•12. Any medical history that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. chronic, relapsing or hereditary disease that may affect the outcome of the study).

发起方

niversita¨t Hamburg Fachrichtung Kosmetikwissenschaft