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

NCT00852241 | Completed Phase 4 Results

• 1 other identifier: CCF4
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infraorbital Hollows

Outcome Measures

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

  1 year

Study Arms (1)

Restalyne and Perlane

EXPERIMENTAL

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

Drug: Restalyne; Drug: Perlane

Interventions

Restalyne DRUG

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

Also known as: Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid

Restalyne and Perlane

Perlane DRUG

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

Also known as: Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid

Restalyne and Perlane

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Hyaluronic Acid; Perlane

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

PI left institution, no data is available.

Results Point of Contact

• Title: Rebecca Tung, MD
• Organization: Loyola Medicine

rtung@loyolamedicine.org

(708) 216-4962

Study Officials

• Rebecca Tung, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: February 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 12, 2018
• Results First Posted: March 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)