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NCT Number: NCT06336044

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

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

Recruiting

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Key information

Conditions

Wrinkle Cicatrix Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Fibrosis Genetic Diseases, Inborn Laxity; Skin Pathologic Processes Pathological Conditions, Signs and Symptoms Scar Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Tor Vergata

Roma, 00133, Italy

Location status: Recruiting

Location contact

Elena Campione, Prof

CONTACT

[email protected]

+393382445642

Elena Campione, Prof

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Karisma

Device

Intradermal injection

Other names: Karisma filler

Primary outcomes

  1. Safety: no adverse events

    Time frame: 16 weeks

    test the safety of the device evaluating any potential adverse event

  2. Efficacy: change of wrinkles and scars

    Time frame: 16 weeks

    test the efficacy of the device measuring the skin surface using GAIS (Global Aesthetic Improvement Scale) scale

  3. Efficacy: change of wrinkles and scars

    Time frame: 16 weeks

    test the efficacy of the device measuring the skin surface using Facial Volume Loss Scale (FVLS)

  4. Efficacy: change of wrinkles and scars

    Time frame: 16 weeks

    test the efficacy of the device measuring the skin surface evaluating the face volume

  5. Efficacy: change of wrinkles and scars

    Time frame: 16 weeks

    test the efficacy of the device measuring the skin surface with skin hydratation measurement

Secondary outcomes

  1. Duration of the efficacy

    Time frame: 16 weeks

    measure the duration of the treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Adolfo Gasparetto, MD

CONTACT

[email protected]

+393356641965

Elena Campione, Professor

CONTACT

[email protected]

+393382445642

Sponsors and collaborators

Lead sponsor

Taumedika s.r.l.

Industry

Collaborators

  • Nextrasearch S.r.l.s.

Registry information

Official study title

"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'"

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2024
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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