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

NCT06000839 | Completed

• 1 other identifier: 21E4451
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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, 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

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline of epidermis hydration higher than 2 AU

  Measured with a Corneometer®

  Baseline, Day 42

Secondary Outcomes (13)

• Change from baseline of epidermis hydration

  Baseline, Day 84

• Change from baseline of cutaneous firmness

  Baseline, Day 42 and Day 84

• Change from baseline of the elasticity

  Baseline, Day 42 and Day 84

• Change from baseline of the tonicity

  Baseline, Day 42 and Day 84

• Change from baseline of the suppleness

  Baseline, Day 42 and Day 84

Other Outcomes (1)

• Collection of reactions at injection sites and adverse events (safety endpoint)

  Baseline, Day 0, Day 14, Day 28, Day 42, Day 84

Study Arms (1)

CELLBOOSTER® Lift

EXPERIMENTAL

Device: (D0) Intradermal injection - micropapula technique; Device: (D14) Intradermal injection - micropapula technique; Device: (D28) Intradermal injection - micropapula technique

Interventions

(D0) Intradermal injection - micropapula technique DEVICE

First injection of the product (3ml) in the medium and lower third of the face (whole face excepted forehead)

CELLBOOSTER® Lift

(D14) Intradermal injection - micropapula technique DEVICE

Second injection of the product (3ml) in the medium and lower third of the face (whole face excepted forehead)

CELLBOOSTER® Lift

(D28) Intradermal injection - micropapula technique DEVICE

Third injection of the product (3ml) in the medium and lower third of the face (whole face excepted forehead)

CELLBOOSTER® Lift

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian
• Phototype II to III
• Subject with signs of cutaneous ageing on the face with mild to moderate wrinkles, skin laxity, dry and dull skin on face.
• Subject with a skin hydration rate on cheekbones \< 60 UA, measured with Corneometer®.
• Subject looking for an improvement using an aesthetic procedure.
• Subject willing to abstain from other facial aesthetic procedure in the full face through the entire study duration.
• Subject having given their free, express, and informed consent.
• Subject psychologically able to understand the information related to the study, and to give their written informed consent.
• Subject registered with a social security scheme.
• Female of childbearing potential must use a medically accepted contraceptive method since at least 12 weeks before the beginning of the study and throughout the study.

You may not qualify if:

• Pregnant or nursing woman or planning a pregnancy during the study.
• Woman menopaused from less than 1 year or in perimenopause, without hormonal treatment.
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject in a social or sanitary establishment.
• Subject having received a total of 4.500 euros as compensations for their participation in research involving human beings in the last 12 months, including their participation in the present study.
• Intensive exposure to sunlight or UV-rays within the previous month and/or planning to do so during the study.
• Subject with a tattoo, a scar, moles or too many hairs or anything on the face which may interfere with the study at the investigator appreciation.
• Subject having resorbable filling product (e.g., hyaluronic acid) injections, a laser treatment, an ultrasound-based treatment, a dermabrasion, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to study start and a facial surgery in the past 2 years
• Subjects having received botulinum toxin in the face within the 9 previous months.
• Subject having received mesotherapy products in the face within the 3 previous months.
• Subject having done a superficial or medium peeling or a superficial scrub on the face within the 2 previous months.
• Subject using cosmetic products with alpha hydroxy acids (AHA).
• Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand).
• Subject having received injections of permanent (e.g., acrylate polymers, silicone, polytetrafluoroethylene) or semi-permanent filling on the face (L Polylactic acid, Calcium Hydroxyapatite...).
• Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).

Sponsors & Collaborators

• Suisselle: lead

Study Sites (1)

Eurofins Dermscan

Villeurbanne, France

Location

MeSH Terms

Conditions

Cutis Laxa; Hyperpigmentation; Striae Distensae; Hypertrophy

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Pigmentation Disorders; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: August 21, 2023
• Study Start: October 7, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

FR (1)