Prospective, randomized, controlled, Investigator Initiated Study to investigate Efficacy and Safety of cell-free Autologous Conditioned Serum (ACS) alone or in combination with hyaluronic acid (HA) in reduced facial skin elasticity by woma
- Conditions
- reduce of facial skin elasticity in healthy volunteers
- Registration Number
- DRKS00011249
- Lead Sponsor
- niversität Hamburg Fachrichtung Kosmetikwissenschaft
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 42
1. Provision of signed and dated informed consent form to participate in the study
2. Non-pregnant female aged 35-65 years
3. High loss of facial skin elasticity according to the Investigator’s opinion
1. Severe skin diseases e.g. psoriasis, atopic eczema (neurodermatitis) or other autoimmune skin diseases
2. Skin cancer in the anamnesis
3. Systemic diseases with skin involvement (SLE)
4. Pre-treatment with laser, botox or hyaluronic acid in the tested face area (treatment areal)
5. Severe diet in the last 3 months or nutritional
supplementary during the last 3 years
6. Acute infection
7. Chronic acne
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gain in skin elasticity measured between baseline and week 12 with the Cutometer dual MPA 580 (Courage Khazaka electronic GmbH, Colonge).
- Secondary Outcome Measures
Name Time Method 1. Intraindividual difference between baseline and week 12 on the „Global Aesthetic Improvement Scale (GAIS).<br><br>2. Intraindividual difference between baseline and week 12 of the patients’ attractivity self-assessment on a 7 point scale<br><br>3. Intraindividual difference between baseline and week 12 on the „Facial Appearance Self-Perception Questionnaire (FASPQ).