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Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds (VINO)

C

Croma-Pharma

Status

Completed

Conditions

Nasolabial Fold, Hypoplastic

Treatments

Device: Princess® VOLUME Lidocaine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03050710
CPH-401-201258

Details and patient eligibility

About

In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME Lidocaine and will return for follow-up assessments 2, 4, 24 and 36 weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female 18 years of age or older
  • Presence of two fully visible, approximately symmetrical nasolabial folds, with each of the folds, scored 2-3 according to the 5-grade Nasolabial Folds Severity Rating Scale
  • Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
  • Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
  • Written signed and dated informed consent

Exclusion criteria

  • Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
  • History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anesthetic
  • Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
  • Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region
  • Cutaneous lesions in the treatment area
  • History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
  • Use of anticoagulant, antiplatelet or thrombolytic medication
  • Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Princess® VOLUME Lidocaine
Other group
Treatment:
Device: Princess® VOLUME Lidocaine

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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