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Restylane Silk for Treatment of Chest Wrinkles

NCT03324997 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-03-06

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and efficacy of using Restylane Silk to reduce the appearance of photoaging on the chest. Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth. This study will compare the appearance of chest wrinkles on half the chest treated with Restylane Silk and the other half, which will be treated with placebo.

Conditions

  • Wrinkle

Interventions

DRUG

Restylane Silk

Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth.

DRUG

Saline

Saline as placebo

DEVICE

Optical Coherence Tomography

An FDA-cleared non-invasive imaging device

Sponsors & Collaborators

  • Heidi Waldorf

    lead OTHER

Principal Investigators

  • Heidi Waldorf, MD · Icahn School of Medicine at Mount Sinai

  • Giselle Singer · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-28
Primary Completion
2018-01-28
Completion
2018-01-28
FDA Drug
Yes
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 NCT03324997 on ClinicalTrials.gov