Lack of facial skin elasticity by healthy volunteers
Conditions
Interventions
Group 1: Intradermal micropuncture of autologous conditioned serum (ACS) into facial skin. 4 injections with 4 ml Serum will be given at week 0, 2, 4 and 6.
Sponsors
Universita¨t Hamburg Fachrichtung Kosmetikwissenschaft
Eligibility
Sex/Gender
Female
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in skin firmness (R0 value) from baseline to 12 weeks and from baseline to 24 weeks. Change in skin tiring (R3 value) from baseline to 12 weeks and from baseline to 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Long term safety of cell-free ACS; 2. Long term changes in skin firmness (R0 value) from baseline to 48 weeks; 3. Long term changes in skin tiring (R3 value) from baseline to 48 weeks; 4. Changes in FACE-Q TM Questionnaires; 5. Changes in patients attractivity self assessment; 6. Changes in GAIS Score (Global aesthetic improvement scale). | — |
Countries
Germany
Contacts
Public ContactMartina Kerscher
Universita¨t Hamburg Fachrichtung Kosmetikwissenschaft
Outcome results
None listed