Trial document




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  DRKS00009259

Trial Description

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Title

Prospective Investigator Initiated Study to investigate Efficacy and Safety of cell-free Autologous Conditioned Serum (ACS) in reduced facial skin elasticity by woman

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Trial Acronym

OrthoSkin

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of this study is to evaluate the effects of micropuncture injections of ACS (Autologous Conditioned Serum) on skin elasticity, a major aspect of skin ageing. Therefore the therapeutic effect of ACS on the skin ageing will be evaluated. 3 (if required 4) Injections with 1 ml Serum on both sides of the face will be done. The effect will be described with methods, which are listed in the section primary and secondary outcome.

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Brief Summary in Scientific Language

The purpose of this study is to evaluate the effects of micropuncture injections of ACS on skin elasticity. The processes by which skin ages are complex and resulting from the interaction of a number of different factors. One of the aging theories is the “Inflammation Theory of Ageing". Briefly, it states that when getting older the constantly increasing pro-inflammatory cytokines are a consequence of bystander damage and the cause of cell deterioration and aging.
Cell-free autologous conditioned serum (ACS) has been shown to be effective in some musculoscelettal disorders and in lumbar radicular compression due to its anti-inflammatory action. For this reason we assume that if the concentration of inflammatory mediators in skin can be reduced, its action and the inflammatory harm they produce can be slowed down too.

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Organizational Data

  •   DRKS00009259
  •   2015/12/22
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  •   yes
  •   Approved
  •   015/1497, Freiburger Ethik-Kommission International
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Secondary IDs

  •   U1111-1177-0924 
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Health Condition or Problem studied

  •   lack of facial skin elasticity by healthy volunteers
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Interventions/Observational Groups

  •   3-4 Micropuncture injections of autologous conditioned serum (ACS) in the face in week 0, 2, 4 and facultative in week 12.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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).

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/12/07
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   35   Years
  •   55   Years
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Additional 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

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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.)

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Addresses

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    • Universität HamburgFachrichtung Kosmetikwissenschaft
    • Ms.  Prof. Dr. med.  Martina  Kerscher 
    • Martin-Luther-King-Platz 6
    • 20146  Hamburg
    • Germany
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    • Universität HamburgFachrichtung Kosmetikwissenschaft
    • Ms.  Prof. Dr. med.  Martina  Kerscher 
    • Martin-Luther-King-Platz 6
    • 20146  Hamburg
    • Germany
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    • Universität HamburgFachrichtung Kosmetikwissenschaft
    • Ms.  Prof. Dr. med.  Martina  Kerscher 
    • Martin-Luther-King-Platz 6
    • 20146  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • ORTHOGEN AG
    • 40212  Düsseldorf
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/08/18
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.