Aesthetic Performance of an Intradermal Injection Treatment for Face Photoaging: Interstitial or Cushion Technique in Comparison to Bolus Technique at Five Points (Half - Face Method Within Subjects)
Condition: Face Photoaging
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      Aesthetic performance of "SUNEKOS® 200" injectable treatment on main sign of face skin aging
      in normotypic or overweight subjects with rounded, oval or squared face and in thin subjects
      with oval or triangular face and "sagging" skin.Interstitial or cushion technique in
      comparison to bolus technique at five points (half - face method within subjects).
    

Detailed description: 
      Spontaneous, open, clinical trial, conducted by one centre under dermatological control.
      Primary end point of the study was to evaluate clinically and by non-invasive instrumental
      measurements the aesthetic performance of "SUNEKOS® 200" injectable treatment on main sign of
      face skin aging in normotypic or overweight subjects with rounded, oval or squared face and
      in thin subjects with oval or triangular face and "sagging" skin.

      The micro-injections of the study product were executed by a specialized dermatologist, on
      the face of female volunteers with photoaging of mild/moderate grade; to improve the
      treatment aesthetic performance two different injection techniques were carried out
      mono-laterally on the left or right face side randomly: "interstitial fluid technique" (IFT)
      for the 1st subjects' typology (aged 35-50 years) and "cushion technique" in association to
      "retrograde interstitial fluid technique" (RIFT) for the 2nd (aged 45-60). On the
      contralateral face side the injection treatment was performed by bolus technique on five
      pre-determined face points, preceding for the 2nd subjects' typology by cushion technique.

      It was also aim of this study to evaluate tolerance both by investigator and volunteers and
      efficacy by the volunteers
    

Intervention name(s): SUNEKOS ® 200; "SUNEKOS® 1200" and "SUNEKOS® 200"
Intervention type(s): Device; Device
Intervention description(s): 4 micro-injection sessions of "SUNEKOS® 200" with an interval of 10 days. Two different injection techniques were carried out mono-laterally on the left or right face side randomly: "interstitial fluid technique" (IFT) on one face side; bolus technique on five pre-determined face points (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) on the contralateral face side.; 5 micro-injection sessions (one of the product "SUNEKOS® 1200" and four of "SUNEKOS® 200". "SUNEKOS® 1200" was injected bi-laterally on the face with cushion technique. 24 hours after the "SUNEKOS® 1200" treatment, 4 micro-injection sessions of "SUNEKOS® 200" with an interval of 10 days were performed . "SUNEKOS® 200" was injected with two different techniques, carried out mono-laterally on the left or right face side randomly: "retrograde interstitial fluid technique" (RIFT) on one face side; bolus technique on five pre-determined face points (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) on the contralateral face side.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment