Prospective Investigator Initiated Study to investigate Efficacy and Safety of cell-free Autologous Conditioned Serum (ACS) in reduced facial skin elasticity by woma
- Conditions
- lack of facial skin elasticity by healthy volunteers
- Registration Number
- DRKS00009259
- Lead Sponsor
- niversität HamburgFachrichtung Kosmetikwissenschaft
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 21
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
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.)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method