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Vollure for the Correction of Atrophic Facial Scarring

NCT04519515 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-02-15

No results posted yet for this study

Summary

Subjects will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right assignment can be repeated. Subjects will return 24-48 hours after their first treatment to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding short term adverse events. Subjects will fill out a 30 day subject diary and also return 30 and 90 days after their last treatment to fill out questionnaires, take pictures, complete the Global Aesthetic Improvement Scale (GAIS), and to be assessed on the QGSGS and for long-term adverse events by blinded evaluators. At 12 months, 18 months, and 24 months, the subjects will return to fill out questionnaires, take pictures, and to be assessed by blinded evaluators for long-term efficacy.

Conditions

  • Atrophic Scar

Interventions

DEVICE

Allergan Vollure

Injection of Allergan Vollure into Atrophic Scars

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Siperstein Dermatology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-11
Primary Completion
2021-09-17
Completion
2023-05-01
FDA Device
Yes

Countries

  • United States

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 NCT04519515 on ClinicalTrials.gov