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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 woman

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 woman - OrthoSkin2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011249
Enrollment
40
Registered
2016-11-09
Start date
2016-11-03
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

reduce of facial skin elasticity in healthy volunteers

Interventions

Group 1: Micropuncture injections of 5 ml autologous conditioned serum (ACS) in the face in week 0, 4, 8 and facultative in week 12. Group 2: Micropuncture injections of 5 ml autologous conditioned s

Sponsors

Universität Hamburg Fachrichtung Kosmetikwissenschaft
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Gain in skin elasticity measured between baseline and week 12 with the Cutometer dual MPA 580 (Courage Khazaka electronic GmbH, Colonge).

Secondary

MeasureTime 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).

Countries

Germany

Contacts

Public ContactMartina Kerscher

Universität Hamburg Fachrichtung Kosmetikwissenschaft

martina.kerscher@uni-hamburg.de+49 (0) 40 42838 7235

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026