NCT03324997

Restylane Silk for Treatment of Chest Wrinkles

Small Particle Hyaluronic Acid-Based Gel (Restylane Silk) for Treatment of Chest Wrinkles: A Randomized, Double-Blinded, Placebo-Controlled, Clinical Trial of Efficacy and Safety

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Heidi Waldorf · Academic / Other
• Sex: Female
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Restylane Silk has been safely and effectively used in rejuvenation and appearance of wrinkles in the face. This study seeks to investigate the safety and efficacy of the injectable device in the chest for similar effects. Participants will undergo three treatments with Restylane Silk and results will be measured clinically and with Optical Coherence Tomography (an FDA-cleared non-invasive imaging device). Participants will receive randomized injections with the Restylane Silk product on half of the chest and will receive placebo injections on the other half. At the six-month period, participants will have the option to receive treatment with the product on the placebo side. At the 12-month period, participants may also elect for three additional touch-up treatments, which will not be counted as part of the study. If the chest is asymmetric in regards to wrinkles, the investigators will still proceed with the protocol because they are also comparing each side to itself prior to treatment, instead of simply comparing one side to the other.

Conditions

• Wrinkle

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-01-28
• Primary completion: 2018-01-28
• Completion: 2018-01-28
• First posted: 2017-10-30
• Last updated: 2018-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study