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Effectiveness and Safety of Princess FILLER Lidocaine in Correction of Nasolabial Folds (NLF)

NCT03990883 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2025-02-04

Study results available
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Summary

Clinical Investigation to demonstrate the effectiveness and safety of Princess Filler Lidocaine in the correction of moderate to severe nasolabial folds

Conditions

  • Dermatological Non-Disease

Interventions

DEVICE

Princess Filler Lidocaine

correction of nasolabial folds

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Croma-Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • David Bank, MD · Center of Dermatology, Cosmetic and Laser Surgery

  • Joel Cohen, MD · AboutSkin research, LLC

  • John Joseph, MDE · Dr. John Joseph Facial Plastic and Reconstructive Surgery

  • Gary Monheit, MD · Total Skin and Beauty Dermatology Center

  • Ava Shamban, MD · Ava MD

  • Susan Taylor, MD · University of Pennsylvania

  • Robert Weiss, MD · Maryland Laser Skin and Vein

  • Sabrina Fabi, MD · Cosmetic, Lazer, Dermatology

  • Jeanine Downie, MD · Image Dermatology P.C.

  • Jeremy Green, MD · Skin Research Institute

  • Michael Gold, MD · Tennesse Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-04
Primary Completion
2020-05-29
Completion
2022-02-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03990883 on ClinicalTrials.gov