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Phase 4 N=18 Treatment

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

Infraorbital Hollows

Bottom Line

View on ClinicalTrials.gov: NCT00852241 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: 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

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Restalyne (Drug); Perlane (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
The Cleveland Clinic
Primary completion
Sep 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
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		 — —

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

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00852241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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