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

NCT06000839 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-08-21

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Suisselle

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-07
Primary Completion
2023-02-01
Completion
2023-02-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06000839 on ClinicalTrials.gov