NCT06000839

A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology)

A Prospective, Open Study on the Safety and Effectiveness of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology) on Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Suisselle · Industry
• Sex: All
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Skin Fold
• Skin Laxity
• Skin Texture Disorder
• Skin Depression
• Skin Dryness
• Hyperpigmentation
• Atrophic Scar
• Striae Distensae
• Oxidative Stress

Interventions

Type	Name	Description
DEVICE	(D0) Intradermal injection - micropapula technique	First injection of the product (3ml) in the medium and lower third of the face (whole face excepted forehead)
DEVICE	(D14) Intradermal injection - micropapula technique	Second injection of the product (3ml) in the medium and lower third of the face (whole face excepted forehead)
DEVICE	(D28) Intradermal injection - micropapula technique	Third injection of the product (3ml) in the medium and lower third of the face (whole face excepted forehead)

Timeline

• Start date: 2022-10-07
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2023-08-21
• Last updated: 2023-08-21

Locations

1 site across 1 country: France