Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'

"Clinical and Instrumental Evaluation of the Safety and Bio-revitalizing Effect on the Face of the Medical Device 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'"

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06336044

Enrollment

Registered

2024-03-28

Start date

2026-02-01

Completion date

2026-06-01

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laxity; Skin, Scar, Wrinkle

Keywords

hyaluronic acid, Collagen, Filler, Wrinkles

Brief summary

Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 40 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events

Detailed description

The patients chosen with facial laxity characteristics, at the first visit will be assessed and will receive the treatment (microinjections) in the cheekbone area, over the lips and in the marionette lines. After 4 weeks the first visit will assess the change of the tissutal structure with non invasive measurements.

Interventions

DEVICEKarisma

Intradermal injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

20 patients for face and 20 for lips will undergo skin characterists measurments at time 0 at +4weeks and at +16 weeks

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* all sexes * caucasic * 18 to 70 years * non smoker

Exclusion criteria

* Pregnancy * milking * smoker * alcohol or drugs abuse * change of BMI during the study * previous facial surgery, implants, permanent treatments * sensitivity to the product * dermatological difficult frame * health weakness * treated with anticoagulants, antihistaminics, corticosteroids, antidepressants and other drugs impacting on the results

Design outcomes

Primary

Measure	Time frame	Description
Safety: no adverse events	16 weeks	test the safety of the device evaluating any potential adverse event
Efficacy: change of wrinkles and scars	16 weeks	test the efficacy of the device measuring the skin surface using GAIS (Global Aesthetic Improvement Scale) scale

Secondary

Measure	Time frame	Description
Duration of the efficacy	16 weeks	measure the duration of the treatment

Countries

Italy

Contacts

CONTACTElena Campione, Professor

elena.campione@uniroma2.it+393382445642

CONTACTAdolfo Gasparetto, MD

adolfogasparetto@nextrasearch.it+393356641965

STUDY_DIRECTORAdolfo Gasparetto, MD

Nextrasearch S.r.l.s.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026