Infraorbital HollowsPhase 4NCT00852241
Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
A Phase 4 study testing Restalyne and Perlane in people with Infraorbital Hollows, run by The Cleveland Clinic at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infraorbital Hollows
- What is being tested?
- Restalyne and Perlane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- No significant medical illness
- Subjects with the willingness and ability to understand and provide informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
Read the detailed description
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.
- Conditions
- Infraorbital Hollows
- Being tested
- Restalyne, Perlane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestalyneDrug
Also called Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid
one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.
PerlaneDrug
Also called Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid
One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Restalyne; Drug: Perlane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infraorbital HollowsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Tung, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852241
- Sponsor's protocol ID
- CCF4
- Status last verified
- Feb 2018
- First submitted
- 25 Feb 2009
- Last updated
- 12 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
- ClinicalTrials.gov ID
- NCT00852241
- Acronym / sponsor ID
- CCF4
- Conditions
- Infraorbital Hollows
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Posted 12 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restalyne and Perlane | Experimental | Drug: Restalyne, Drug: PerlaneOne syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and older
- No significant medical illness
- Subjects with the willingness and ability to understand and provide informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RestalyneAlso: Hyaluronan; Hyaluronate Sodium; Hyaluronic Acidone syringe of Restylane® (1.0cc) will be used total for both tear trough areas. | Drug | Restalyne and Perlane |
| PerlaneAlso: Hyaluronan; Hyaluronate Sodium; Hyaluronic AcidOne syringe of Perlane® (1.0cc) will be used total for both tear trough areas. | Drug | Restalyne and Perlane |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Infraorbital Hollows
Not yet recruitingPhase 2
Phase 2 Evaluation of Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB) Injection for the Treatment of Infraorbital Hollowing
Infra-orbital Hollows, Skin Quality Improvement
Recruiting
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Lips Enhancement, Perioral Wrinkles
Recruiting
TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese Adults
Infraorbital Hollows
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Tung, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Restalyne and Perlane in people with Infraorbital Hollows, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.