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LifeSprout Lumina™ Study in the Treatment of Nasolabial Folds

NCT04839484 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2022-09-10

No results posted yet for this study

Summary

The study will be a prospective, randomized, split-face, double blind, controlled, clinical trial to evaluate the safety and effectiveness of Lumina™ for the treatment of Nasolabial Folds (NLFs). Subjects will be randomized to receive treatment (Lumina™) in one NLF and control (Restylane® Defyne) in the contra-lateral NLF. 118 subjects will be treated.

Conditions

  • Nasolabial Fold

Interventions

DEVICE

Study Product

up to 2cc per injection of filler placed into nasolabial fold.

DEVICE

Active Control

up to 2cc per injection of filler placed into nasolabial fold.

Sponsors & Collaborators

  • Health Policy Associates

    collaborator UNKNOWN

  • LifeSprout, Inc.

    lead INDUSTRY

Principal Investigators

  • Sashank Reddy, M.D. · LifeSprout, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2022-09-04
Completion
2023-03-31
FDA Device
Yes

Countries

  • Belgium
  • Portugal
  • United Kingdom

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 NCT04839484 on ClinicalTrials.gov