Temporal HollowingNCT05691972

Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing

A study testing Restylane Contour in people with Temporal Hollowing, run by Galderma R&D at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane® Contour in correction of temple hollowing. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Temporal Hollowing
What is being tested?: Restylane Contour
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 225 participants
Where: 15 sitesUnited States
Study dates: 14 Mar 2023to 11 Dec 2024
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

Males or non-pregnant, non-breastfeeding females, 22 years of age or older
Intent to undergo treatment for correction of temple hollowing

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 or nerve blocking agents (if intended to be used for that subject)
Previous facial surgery (e.g., facelift) above the level of the horizontal line from subnasale that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments
Any previous aesthetic procedures or implants
Recurrent temporal headaches such as temporal tendinitis migraine. Have a history of migraines or frequent headaches, as determined by the (Treating) Investigator, that could interfere with the study safety and/or effectiveness assessments

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Galderma Research Site
Adventura, Florida, 33180
Galderma Research Site
Boynton Beach, Florida, 33437
Galderma Research Site
Chapel Hill, North Carolina, 27517
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 Orleans, Louisiana, 70115
Galderma Research Site
New York, New York, 10021
Galderma Research Site
Phoenix, Arizona, 85054
Galderma Research Site
Redondo Beach, California, 90277
Galderma Research Site
Solana Beach, California, 92075
Galderma Research Site
Vista, California, 92083
Galderma Research Site
Washington D.C., District of Columbia, 20037
Galderma Research Site
Wilmington, North Carolina, 28405

Other trials in United States

About this study

Official title: A Randomized, No-treatment-controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing

This is a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane® Contour in correction of temple hollowing.

Conditions: Temporal Hollowing
Being tested: Restylane Contour

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Restylane ContourDevice
a sterile, biodegradable, transparent gel of nonanimal cross-linked HA (20 mg/mL) with the addition of lidocaine hydrochloride (3 mg/mL)

Study groups in NCT05691972
Study group	Role	What they receive
Treatment	Experimental	Not described Receives: Device: Restylane Contour
Control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Responder Rate Based on the Blinded Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS)
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% confidence interval (CI) were calculated using the normal approximation (Wald) method.
Measured: Baseline, Month 3

Secondary outcomes (2)

Responder Rate Based on GTVDS at Month 3 as Assessed by Blinded Evaluator Compared to a Reference Standard Responder Rate of 50%
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% CI were calculated using the normal approximation (Wald) method. Responder rate based on the GTVDS, as assessed by blinded evaluator at Month 3, compared with a reference standard responder rate of 50%.
Measured: Baseline, Month 3
Responder Rate Based on GTVDS at Months 6, 9 and 12 as Assessed by Blinded Evaluator
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% CI were calculated using the normal approximation (Wald) method. Responder rate based on the GTVDS, as assessed by a blinded evaluator at Months 6, 9 and 12 are reported here.
Measured: Months 6, 9 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 202311 Dec 2024

First posted20 Jan 2023
Study start14 Mar 2023
Primary completion26 Oct 2023
Study completion11 Dec 2024

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 Temporal HollowingStudies 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: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05691972
Sponsor's protocol ID: 43USTH2201
Status last verified: Apr 2026
First submitted: 11 Jan 2023
Last updated: 22 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, No-treatment-controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing
ClinicalTrials.gov ID: NCT05691972
Acronym / sponsor ID: 43USTH2201
Conditions: Temporal Hollowing
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 14 Mar 2023 (actual)
Primary completion: 26 Oct 2023 (actual)
Study completion: 11 Dec 2024 (actual)
First posted: 20 Jan 2023 (actual)
Results: Posted 22 May 2026

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 randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane® Contour in correction of temple hollowing.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Device: Restylane Contour
Control	No intervention	–

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Males or non-pregnant, non-breastfeeding females, 22 years of age or older
Intent to undergo treatment for correction of temple hollowing

Key exclusion criteria (5 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 or nerve blocking agents (if intended to be used for that subject)
Previous facial surgery (e.g., facelift) above the level of the horizontal line from subnasale that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments
Any previous aesthetic procedures or implants
Recurrent temporal headaches such as temporal tendinitis migraine. Have a history of migraines or frequent headaches, as determined by the (Treating) Investigator, that could interfere with the study safety and/or effectiveness assessments

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 Contoura sterile, biodegradable, transparent gel of nonanimal cross-linked HA (20 mg/mL) with the addition of lidocaine hydrochloride (3 mg/mL)	Device	Treatment

Primary outcome

Responder Rate Based on the Blinded Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS)
Time frame: Baseline, Month 3
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% confidence interval (CI) were calculated using the normal approximation (Wald) method.

2 secondary outcomes

Responder Rate Based on GTVDS at Month 3 as Assessed by Blinded Evaluator Compared to a Reference Standard Responder Rate of 50%
Time frame: Baseline, Month 3
Responder Rate Based on GTVDS at Months 6, 9 and 12 as Assessed by Blinded Evaluator
Time frame: Months 6, 9 and 12

Results and safety

Results posted to the registry on 22 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Restylane Contour	181	163
No-treatment Control Group	44	40

Primary outcome: Responder Rate Based on the Blinded Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS)

Time frame: Baseline, Month 3. Number (97.5% Confidence Interval). Unit: percentage of participants

Measure	Restylane Contour n = 181	No-treatment Control Group n = 44
Value	91.2 (86.85 to 95.47)	9.1 (0.73 to 19.27)

Restylane Contour vs No-treatment Control Group: Treatment difference: 78.5 (97.5% CI 65.73 to 89.11), p <0.001, Chi-squared

Population analysed: Analysis was performed on the ITT population. The ITT population included all participants who were randomized and were analyzed according to the randomization scheme.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline up to 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Restylane Contour	7 of 181 (3.9%)	61 of 181 (33.7%)	0 of 181
No-treatment Control Group	1 of 43 (2.3%)	10 of 43 (23.3%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Study Director study director

Galderma R&D

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Restylane Contour in people with Temporal Hollowing, run by Galderma R&D at 15 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 2 inclusion and 5 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 22 May 2026). 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 Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS) (time frame: Baseline, Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05691972.

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 22 May 2026.