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Prospective, randomized, controlled IIS to compare efficacy and safety of cell-free Exokine® derived Serum (EdS) in four different application routes in men and women with reduced facial skin elasticity

Prospective, randomized, controlled IIS to compare efficacy and safety of cell-free Exokine® derived Serum (EdS) in four different application routes in men and women with reduced facial skin elasticity - Exokine Practice Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015105
Enrollment
40
Registered
2019-01-29
Start date
2019-03-19
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: Application of 4 ml cell-free Exokine® derived Serum (EdS) in week 0, 2, 4 and 6 via mesotherapy gun in facial skin Group 2: Application of 4 ml cell-free Exokine® derived Serum (EdS) in week

Sponsors

Center for molecular orthopaedics and regenerative medicine (CEMOR)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 30-65 years old females and males; 2. Apparent loss of facial skin elasticity; 3. Signed informed written Patient Informed Consent Form;

Exclusion criteria

Exclusion criteria: 1. Severe skin diseases eg 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, Botulinum Toxin or hyaluronic acid (HA) in the tested area. 5. Recently started diet (less than 3 months) or nutritional supplementary (less than 3 years); 6. Any kind of acute infection; 7. Chronic Acne; 8. Pregnancy.

Design outcomes

Primary

MeasureTime frame
Change of the „Global Aesthetic Improvement Scale“ (GAIS) between baseline and week 12 and baseline and week 24.

Secondary

MeasureTime frame
Changes in the questionnaire "Patients Attractivity Self-Estimation Score" between baseline and week 12 and baseline and week 24. Collection of adverse reactions of cell-free Exokine® derived Serum (EdS) over the whole period of the trial.

Countries

Germany

Contacts

Public ContactNancy Safaian

Center for molecular orthopaedics and regenerative medicine (CEMOR)

nancysafaian@orthogen.com+49 (0) 211 – 60 255-0

Outcome results

None listed

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