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Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%

NCT03273556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-09-06

No results posted yet for this study

Summary

Evaluation of the filler performance on the nasolabial folds of Aliaxin® EV with and without lidocaine 0.3%: comparison within subjects (half face method)

Conditions

  • Nasolabial Folds Correction

Interventions

DEVICE

Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%

The injective treatment was performed, during T0 visit after the basal evaluations, mono-laterally on nasolabial fold,(right or left face side in according to a previously defined randomisation list). A quantity of Aliaxin® Ev (up to a maximum of 0.5 ml) with Lidocaine 0.3% was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.

DEVICE

Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.)

The injective treatment was performed on the contralateral nasolabial fold during T0 visit, after the basal evaluations . A quantity of Aliaxin® Ev up to a maximum of 0.5 ml was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.

Sponsors & Collaborators

  • Derming SRL

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-28
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Italy

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 NCT03273556 on ClinicalTrials.gov