lack of facial skin elasticity by healthy volunteers
Conditions
Interventions
Group 1: 3-4 Micropuncture injections of autologous conditioned serum (ACS) in the face in week 0, 2, 4 and facultative in week 12.
Sponsors
Universität HamburgFachrichtung Kosmetikwissenschaft
Eligibility
Sex/Gender
Female
Age
35 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated informed consent form to participate in the study 2. Non-pregnant, non-breast feeding female aged 35-55 years 3. Loss of facial skin elasticity according to the Investigator’s opinion 4.Intent to improve skin structure and the elasticity of the skin using cell-free ACS
Exclusion criteria
Exclusion criteria: 1. Severe skin diseases e.g. psoriasis, atopic eczema (neurodermatitis), acne, active herpes zoster or other autoimmune skin diseases in the face 2. Skin cancer in the anamnesis 3. Treatment with chemotherapy, immunosuppressive agents or immunomodulatory therapy (e.g. corticosteroids, monoclonal antibodies) within three months before study treatment. 4. Systemic diseases with skin involvement (SLE) 5. Pre-treatment with laser, botox or hyaluronic acid in the lower face (treatment areal) 6. Severe diet in the last 3 months or nutritional supplementary during the study duration of 24 week 7. Acute infection 8. Pregnancy or woman who plan to become pregnant during the course of the study 9. History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation (e.g. ASS or other non-steroidal anti-inflammatory drugs [NSAIDs]) 10. Tendency to form keloids, hypertrophic scars or other healing disorder 11. 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 |
|---|---|
| Gain in skin elasticity measured with the Cutometer dual MPA 580 (Courage Khazaka electronic GmbH, Colonge). The penetration depth of the skin into the aperture is measured in mm per time in seconds at 450 mbar. Different device specific parameters are evaluated. These are for example: R0 (firmness), R2 (gross elasticity), R5 (net elasticity) R7 (portion of the elasticity compared to the complete curve) or R9 (Tiring effect /Fatigue). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intraindividual difference between baseline and week 12 on the „Global Aesthetic Improvement Scale“ (GAIS). 2. Intraindividual difference between baseline and week 12 of the patients’ attractivity self-assessment on a 7 point scale 3. Intraindividual difference between baseline and week 12 on the „Facial Appearance Self-Perception Questionnaire" (FASPQ). 4. Intraindividual difference between baseline and week 12 on the „Merz Scale“. 5. Intraindividual difference between baseline and week 12 with standardized photographic devices (Photodocumentationsystem Mediscope HD - FotoFinder System und Visia). Pictures are taken frontal, at a 45° and 90° angel left and right of the face. There will be evaluated an optical difference before and after treatment. 6. Intraindividual difference between baseline and week 12 of the skins’ hydration. Measured with the Corneometer® CM 825 which gives values of the as content of water in skin as arbitrary unit from 0 to 120 (no water to highest value). 7. Intraindividual difference between baseline and week 12 of the skin topography. Measured with the PRIMOS (fringe projection method). Percentage of the an wrinkle areal, average wrinkle depth, maximum average wrinkle depth, maximum wrinkle depth or the volume of all wrinkles can be evaluated. Additional the skin roughness can be evaluated with different parameter like maximum depth of roughness (Rt), average depth of roughness (Rz) or average roughness (Ra). 3D pictures are taken in a mm to µm range. 8. Intraindividual difference between baseline and week 12 of the skin density and skin thickness measured with the high frequency and high resolution ultrasound system DUB 20 Taberna Pro Medicum with 22 MHz and 50 MHz on both sides of the jawline. | — |
Countries
Germany
Contacts
Public ContactMartina Kerscher
Universität HamburgFachrichtung Kosmetikwissenschaft
Outcome results
None listed