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OpenTrials
Completed

NCT Number: NCT00852241

Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study

The primary objective of this study is to determine the efficacy and longevity of the use of Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and to measure patient satisfaction with this treatment

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

This study will examine the effectiveness of using Restylane® and Perlane® together in the treatment of the hollows in the under eye area. The combination of these treatments for use in the under eye area is considered investigational. An investigational therapy is a therapy that is not approved by the US Food and Drug Administration (FDA). Restylane® and Perlane® has been approved for treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds by the FDA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years and older
  • No significant medical illness
  • Subjects with the willingness and ability to understand and provide informed consent

Exclusion criteria

  • Under 18 years of age
  • Pregnancy or Lactation
  • Subjects who have had previous surgical treatment of the lower eyelid area or previous use of filling agents in the under eye area
  • Subjects with a known allergy to the components in Restylane® or Perlane®
  • Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
  • Subjects with liver/kidney disease or compromise or who are immunocompromised
  • Subjects with a known susceptibility to keloid formation or hypertrophic scarring
  • Subjects with an open, non-healing sore or infection near the site of injections
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with mental illness

Treatment and study plan

Restalyne

Drug

one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.

Other names: Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid

Perlane

Drug

One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.

Other names: Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid

Primary outcomes

  1. The Primary Objective of This Study is to Determine the Efficacy and Longevity of the Use of Restylane® and Perlane® in Combination for the Rejuvenation of the Infraorbital Hollows and to Measure Patient Satisfaction With This Treatment

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 26, 2009
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.