A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology)
Condition: Skin Fold; Skin Laxity; Skin Texture Disorder; Skin Depression; Skin Dryness; Hyperpigmentation; Atrophic Scar; Striae Distensae; Oxidative Stress
MeSH terms: Cutis Laxa; Hyperpigmentation; Atrophy; Striae Distensae; Depression
Study type: Interventional

Summary: 
      The current post-market clinical investigation has been designed to evaluate the efficacy and
      safety of CELLBOOSTER® Lift, a HA-based product marketed by SUISSELLE SA. For this purpose,
      healthy subjects with signs of skin aging with mild to moderate wrinkles, skin laxity, dry
      and dull skin on the face, received a 3-session treatment and were followed-up over a 4-month
      period after the initial injection.

      Several objective measurements of skin quality were performed with different parameters: skin
      elasticity, density, dryness, microcirculation, wrinkles, color/homogeneity. Clinical
      improvement was also evaluated, as well as subject and investigator satisfactions.

      The safety of the injections was also followed with injection site reactions and adverse
      events collection.
    

Detailed description: 
      With age and UV exposure, skin undergoes morphologic and mechanical changes that manifest as
      wrinkling, sagging, loss of elasticity and dryness. In particular, decreased synthesis of
      collagen and elastin and their increased degradation reduced proliferative capacity of
      fibroblasts. Moreover, the perturbations in the organisation of elastic fibre network lead to
      alterations in the mechanical properties of the skin with reduced resilience and elasticity.
      Advances in the knowledge of the biochemical mechanisms associated with ageing have led to
      the development of different approaches to reduce and repair its untoward effects,
      particularly by using minimally invasive procedures. Originally developed to treat vascular
      and lymphatic disorders, mesotherapy has recently been used for skin rejuvenation.

      Mesotherapy consists of the stimulation of skin biorejuvenation via minimally invasive
      epidermis or intradermal injections of biologically active substances. The injected
      ingredients are released over a prolonged period of time into the surrounding tissues, with a
      depot-like effect. Among the products available for skin rejuvenation by mesotherapy,
      hyaluronic acid (HA) plays an important role in the moisturization due to its high ability to
      attract water molecules. Given all the above, HA was a clear natural candidate for such
      applications, and non-crosslinked HA gels are by far the most popular compounds employed for
      mesotherapy, both alone and in combination with other molecules. Mesotherapy with HA aids in
      restoring cutaneous metabolic function, water retention and elasticity, with an altogether
      improvement in the visible signs of photoaging. The efficacy of non-crosslinked HA injections
      for the treatment of photoaged skin has been widely reported.

      HA-based injections may be supplemented with other active ingredients for additional,
      synergistic benefits, on condition the compounds be biocompatible and absorbable, such as
      vitamins, antioxidants and/or amino acids.

      Clinical experience of skin rejuvenation by HA-based mesotherapy suggests this technique is
      safe inasmuch as it is performed by a trained physician, who follows safe-injection practices
      with appropriate aseptic techniques to prevent, among other, the risk of infection related to
      inadequate safety measures. Furthermore, several studies suggest mesotherapy can improve skin
      hydration, firmness and viscoelastic properties. Usually, this type of treatment includes an
      intensive course with 3 treatments with 2-3 weeks interval, followed by a support course with
      one treatment per month. The number of treatments needed will depend on the patients (age,
      skin condition, answer to initial treatment,….).

      SUISSELLE has marketed in 2021 the HA-based product CELLBOOSTER® Lift (CBL). CBL consists in
      a stabilized HA complex with amino acids and vitamins for injection in the epidermis or
      dermis.

      The current post-market clinical investigation is designed to evaluate the efficacy and
      safety of CBL. For this purpose, healthy subjects with signs of skin aging with mild to
      moderate wrinkles, skin laxity, dry and dull skin on the face, received a 3-session treatment
      and were followed-up over a 4-month period after the initial injection.

      Several objective measurements of skin quality were performed with different parameters: skin
      elasticity, density, dryness, microcirculation, wrinkles, color/homogeneity. Clinical
      improvement was also evaluated, as well as subject and investigator satisfactions.

      The safety of the injections was also followed with injection site reactions and adverse
      events collection.
    

Intervention name(s): (D0) Intradermal injection - micropapula technique; (D14) Intradermal injection - micropapula technique; (D28) Intradermal injection - micropapula technique
Intervention type(s): Device; Device; Device
Intervention description(s): First injection of the product (3ml) in the medium and lower third of the face (whole face excepted forehead); Second injection of the product (3ml) in the medium and lower third of the face (whole face excepted forehead); Third injection of the product (3ml) in the medium and lower third of the face (whole face excepted forehead)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin Fold; Skin Laxity; Skin Depression; Skin Texture Disorder; Skin Dehydration; Skin Dryness; Skin Quality; Microvascular Circulation; Hyperpigmentation; Oxidative Stress; Atrophic Scar; Striae Distensae; Acne Scars - Mixed Atrophic and Hypertrophic; Epidermis; Dermis; Aesthetic Effect; Aesthetic; Face Treatment; Injection; Micro Papula; Papula; Injection Protocol; Healthy Subjects; Adverse Events; Adverse Effects; Efficacy; Safety; Performance; CELLBOOSTER; Lift; SUISSELLE