Infraorbital HollowsNCT04154930
Restylane-L for Correction of Infraorbital Hollows
A study testing Restylane-L® in people with Infraorbital Hollows, run by Galderma R&D at 16 sites in United States.
Trial summary
This is a prospective, randomized, evaluator-blinded, no-treatment controlled, parallel group, multi-center US study to evaluate the safety and effectiveness of Restylane-L® for correction of Infraorbital Hollows. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Infraorbital Hollows
- What is being tested?
- Restylane-L®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 16 sitesUnited States
- Study dates
- 11 Nov 2019to 6 Apr 2022
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate or severe infraorbital hollows with no more than one grade difference between the left and right side at baseline as assessed by the blinded evaluator.
- Males or non-pregnant, non-breastfeeding females, over the age of 21.
- Intent to undergo correction of both orbital hollows.
Who cannot join
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
- Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
- Previous deep and/or superficial facial dermal therapies.
- Active or a history of recurrent or chronic infraorbital edema or rosacea or uncontrolled severe seasonal allergies.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Galderma Research Site
Boynton Beach, Florida, 33472
Galderma Research Site
Chestnut Hill, Massachusetts, 02467
Galderma Research Site
Chicago, Illinois, 60654
Galderma Research Site
Coral Gables, Florida, 33146
Galderma Research Site
Encino, California, 91436
Galderma Research Site
Los Angeles, California, 90069
Galderma Research Site
Nashville, Tennessee, 37203
Galderma Research Site
New York, New York, 10003
Galderma Research Site
New York, New York, 10021
Galderma Research Site
Redondo Beach, California, 90277
Galderma Research Site
Rochester, New York, 14564
Galderma Research Site
Solana Beach, California, 92075
Galderma Research Site
Spring, Texas, 77388
Galderma Research Site
West Palm Beach, Florida, 33401
Galderma Research Site
Westport, Connecticut, 06880
Galderma Research Site
Wilmington, North Carolina, 28405
About this study
Official title: A Randomized, Evaluator-blinded, Parallel Group, No-treatment Controlled, Multi-center Study to Evaluate the Safety and Effectiveness of Restylane-L® for Correction of Infraorbital Hollows
This is a prospective, randomized, evaluator-blinded, no-treatment controlled, parallel group, multi-center US study to evaluate the safety and effectiveness of Restylane-L® for correction of Infraorbital Hollows.
- Conditions
- Infraorbital Hollows
- Being tested
- Restylane-L®
- Keywords
- Tear Trough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane-L®Device
Intradermal injection.
| Study group | Role | What they receive |
|---|---|---|
| Restylane-L Treatment | Experimental | Restylane-L® injected with optional touch-up at 1 month and optional retreatment at 12 months. Receives: Device: Restylane-L® |
| No Treatment Control | No intervention | No treatment control with optional treatment at 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Infraorbital Hollows Scale (GIHS)
Responder rate was defined as the percentage of participants with at least a 1-point improvement from baseline on the Galderma Infraorbital Hollows Scale (GIHS), on both sides of the face, concurrently. GIHS is a validated 4-point scale used to assess Infraorbital Hollows: 0 (none [hollowness]), 1 (mild [hollowness]), 2 (moderate [hollowness]), 3 (severe [hollowness]). Higher score means more severe (worse) hollowness in the infraorbital Hollows.
Measured: At 3 months after Baseline
Secondary outcomes (3)
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GIHS at 6, 9, and 12 Months After Baseline And at 3 and 6 Months After Optional Treatment
Responder rate was defined as the percentage of participants with at least a 1-point improvement from baseline on the GIHS, on both sides of the face, concurrently at each of the timepoints. GIHS is a validated 4-point scale used to assess Infraorbital Hollows: 0 (none [hollowness]), 1 (mild [hollowness]), 2 (moderate [hollowness]), 3 (severe [hollowness]). Higher score means more severe (worse) hollowness in the infraorbital Hollows.
Measured: At 6, 9, and 12 months after Baseline and at 3 and 6 months after optional treatment
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to live assess the aesthetic improvement of the infraorbital hollows by responding to the question: "How would you describe the aesthetic improvement of your tear troughs today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.
Measured: At 1, 3, 6, 9, and 12 months after randomization, at 1 month after optional touch-up, and at 1, 3 and 6 months after optional treatment
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment
GAIS responder rates are based on independent assessments by the Treating Investigator. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the treating investigator to live assess the aesthetic improvement of the infraorbital hollows by responding to the question: "How would you describe the aesthetic improvement of participant's tear troughs today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.
Measured: At 1, 3, 6, 9, and 12 months after randomization, at 1 month after optional touch-up, and at 1, 3 and 6 months after optional treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start11 Nov 2019
- Primary completion31 Jan 2021
- Study completion6 Apr 2022
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 Galderma R&DThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154930
- Sponsor's protocol ID
- 43USTT1904
- Status last verified
- Apr 2023
- First submitted
- 5 Nov 2019
- Last updated
- 25 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-blinded, Parallel Group, No-treatment Controlled, Multi-center Study to Evaluate the Safety and Effectiveness of Restylane-L® for Correction of Infraorbital Hollows
- ClinicalTrials.gov ID
- NCT04154930
- Acronym / sponsor ID
- 43USTT1904
- Conditions
- Infraorbital Hollows
- Keywords
- Tear Trough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Posted 25 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, evaluator-blinded, no-treatment controlled, parallel group, multi-center US study to evaluate the safety and effectiveness of Restylane-L® for correction of Infraorbital Hollows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane-L Treatment | Experimental | Device: Restylane-L®Restylane-L® injected with optional touch-up at 1 month and optional retreatment at 12 months. |
| No Treatment Control | No intervention | –No treatment control with optional treatment at 12 months. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate or severe infraorbital hollows with no more than one grade difference between the left and right side at baseline as assessed by the blinded evaluator.
- Males or non-pregnant, non-breastfeeding females, over the age of 21.
- Intent to undergo correction of both orbital hollows.
Key exclusion criteria (4 listed)
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
- Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
- Previous deep and/or superficial facial dermal therapies.
- Active or a history of recurrent or chronic infraorbital edema or rosacea or uncontrolled severe seasonal allergies.
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 |
|---|---|---|
| Restylane-L®Intradermal injection. | Device | Restylane-L Treatment |
Primary outcome
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Infraorbital Hollows Scale (GIHS)
Time frame: At 3 months after Baseline
Responder rate was defined as the percentage of participants with at least a 1-point improvement from baseline on the Galderma Infraorbital Hollows Scale (GIHS), on both sides of the face, concurrently. GIHS is a validated 4-point scale used to assess Infraorbital Hollows: 0 (none [hollowness]), 1 (mild [hollowness]), 2 (moderate [hollowness]), 3 (severe [hollowness]). Higher score means more severe (worse) hollowness in the infraorbital Hollows.
3 secondary outcomes
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GIHS at 6, 9, and 12 Months After Baseline And at 3 and 6 Months After Optional Treatment
Time frame: At 6, 9, and 12 months after Baseline and at 3 and 6 months after optional treatment
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
Time frame: At 1, 3, 6, 9, and 12 months after randomization, at 1 month after optional touch-up, and at 1, 3 and 6 months after optional treatment
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment
Time frame: At 1, 3, 6, 9, and 12 months after randomization, at 1 month after optional touch-up, and at 1, 3 and 6 months after optional treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane-L® in people with Infraorbital Hollows, run by Galderma R&D at 16 sites 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 4 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2023). 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?
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Infraorbital Hollows Scale (GIHS) (time frame: At 3 months after Baseline). 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 25 Apr 2023.