Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06000839
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2023-05-08
Brief Title:
A Safety and Effectiveness Study of CELLBOOSTER Lift Stabilized Booster Complex Using CHAC Technology
Sponsor:
Suisselle
Organization:
Suisselle
Study Overview
Official Title:
A Prospective Open Study on the Safety and Effectiveness of CELLBOOSTER Lift Stabilized Booster Complex Using CHAC Technology on Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 colorhomogeneity 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
Several objective measurements of skin quality were performed with different parameters skin elasticity density dryness microcirculation wrinkles colorhomogeneity 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 andor 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 colorhomogeneity 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
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 andor 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 colorhomogeneity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None