Temple HollowingNCT06665477
Evaluate the Effectiveness and Safety of Restylane Volyme in the Treatment of Temple Hollowing
A study testing Restylane Volyme in people with Temple Hollowing, run by Galderma R&D at 1 site in China.
Trial summary
A randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Volyme in the treatment of temple hollowing Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temple Hollowing
- What is being tested?
- Restylane Volyme
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study. Signed and dated informed consent to participate in the study.
- Males or non-pregnant, non-breastfeeding females of Chinese origin and 18 years of age or older at the time of signing the Informed Consent Form (ICF).
- Grade 2 (moderate) to 3 (severe) on the 4-grade GTVDS for both temples as assessed by the Blinded Evaluator as well as the Treating Investigator on Day 1 (agreement on grade is not required). The GTVDS grade for the right temple and the left temple does not have to be equal but must not differ by more than 1 grade.
- Willing to abstain from any other facial plastic surgical or cosmetic procedures above the level of the horizontal line from subnasale for the duration of the study (e.g., laser or chemical resurfacing, needling, facelift, lifting threads, radiofrequency etc.).
- Intent to undergo treatment for correction of temple hollowing.
- If the subject is a female of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test (UPT) or a serum HCG (blood test [if UPT is not available]) at screening, baseline and prior to receiving any study treatment.
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- Acceptable forms of effective birth control include:
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical caps) with spermicidal foam/gel/film/cream/suppository;
- Bilateral tubal ligation;
- Combined oral contraceptives (estrogens and progesterone), implanted or injectable contraceptives on a stable dose for at least 28 days prior to Day 1;
- Hormonal or copper intra uterine device (IUD) inserted at least 28 days prior to Day 1;
- Vasectomized partner (in monogamous relationship) for at least 3 months prior to screening;
- Strict abstinence (at least one month prior to baseline and agrees to continue for the duration of the study or use acceptable form of birth control).
- Negative pregnancy test for women of childbearing potential at the screening and baseline visits.
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 or present severe or multiple allergies manifested by severe reactions, such as anaphylaxis or angioedema, or family history of these conditions.
- 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:
- Previous permanent filler or implant, lifting threads, or autologous fat in the face regardless of time.
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- Previous use of calcium hydroxylapatite (CaHA) or poly-L-lactic acid (PLLA) above the level of the horizontal line from subnasale within 24 months.
- Previous HA filler or collagen filler above the level of the horizontal line from subnasale within 12 months.
- Previous botulinum toxin treatment above the level of the horizontal line from subnasale within 6 months.
- Previous energy based aesthetic procedures (e.g., laser, intense pulsed light, radiofrequency, photomodulation and ultrasound) above the level of the horizontal line from subnasale within 6 months.
- Previous mechanical (e.g., dermabrasion, needling) or chemical aesthetic procedures (e.g., chemical peel) above the level of the horizontal line from subnasale within 6 months.
- Previous treatment with cryotherapy above the level of the horizontal line from subnasale within 6 months.
- History of cancer or previous radiation above the level of the horizontal line from subnasale.
- Presence of any disease or lesions near or on the area to be treated, e.g.:
- Inflammation, active or chronic infection (e.g., in mouth, dentals, head, eye);
- Facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes simplex or herpes zoster;
- Scars or deformities;
- Cancer, or precancerous conditions (e.g., actinic keratosis or actinic cheilitis).
- Evidence of scar-related disease or delayed healing activity within 1 year prior to the baseline visit, or subjects susceptible to keloid formation, hyperpigmentation or hypertrophic scarring in the opinion of the Investigator.
- Presence of tattoo, piercing, beard or facial hair, which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessment.
- 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.
- History of temporomandibular joint disorder, jaw pain, chewing pain or muscular related pain in the treatment area.
- Temple hollowing due to trauma, congenital malformations, or lipodystrophy, either congenital or acquired.
- Experienced trauma to the temple area within 6 months before enrollment or has residual deficiencies, deformities, or scarring.
- Temporal arteritis or history of temporal arteritis.
- Presence of a dental, oral, or facial condition which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessments, e.g., has dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities. Any planned procedure (e.g., dental implants, tooth extractions, orthodontia) during the study period, that would make the subject unsuitable for inclusion in the opinion of the Investigator.
- Abnormal/moderate or abnormal/severe score for temple firmness or detection of any abnormal temple structure, such as lump/mass formation or non-uniform density.
- Abnormal/moderate or abnormal/severe score for temple symmetry.
- An underlying known disease, a surgical or medical condition that would expose the subject to undue risk, e.g., history of bleeding disorders, active hepatitis, active autoimmune disease such as, connective tissue diseases systemic lupus erythematosus, polymyositis, dermatomyositis, or scleroderma.
- Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation (e.g., direct factor Xa inhibitors, warfarin, clopidogrel, aspirin or other non-steroidal anti-inflammatory drugs [NSAIDs], Omega 3 or Vitamin E), within 14 days prior to injection. Omega 3 and Vitamin E are acceptable only as part of a standard multivitamin formulation. Cyclooxygenase-2 (COX 2) inhibitors are allowed.
- Treatment with chemotherapy, immunosuppressive agents, systemic corticosteroids within 3 months before treatment (inhaled corticosteroids are allowed).
- Use of topical facial corticosteroids or prescription retinoids near or on the area to be treated within 1 month of the baseline visit or systemic retinoid treatment within 6 months of the baseline visit, or plan to receive such treatment during participation in the study.
- Presence of any condition or situation, which in the opinion of the Treating Investigator makes the subject unable to complete the study per protocol, e.g.
- Subject is not likely to avoid other prohibited facial cosmetic treatments;
- Subject is not likely to complete the study because of other commitments;
- Subject is anticipated to be unavailable for visits, incapable of understanding the investigational assessments or having unrealistic expectations of treatment result;
- Subject who has a concomitant condition (e.g., acute viral or bacterial infection with fever) that might confuse or confound study treatments or assessments.
- Study center personnel, close relatives of the study center personnel (e.g., parents, children, siblings, or spouse), employees or close relatives of employees at the Sponsor company.
- Participation in any other interventional clinical study within 30 days before treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Galderma Investigational Site #6340
Beijing, Beijing Municipality, 100000
About this study
Official title: A Randomized, No-treatment-controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Volyme in the Treatment of Temple Hollowing
A randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Volyme in the treatment of temple hollowing
- Conditions
- Temple Hollowing
- Being tested
- Restylane Volyme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane VolymeDevice
Subjects in Restylane Volyme treatment group will receive treatment on Day 1 and optiponal treatment 1 month later.
| Study group | Role | What they receive |
|---|---|---|
| Subject treated with Restylane Volyme | Experimental | Not described Receives: Device: Restylane Volyme |
| Subject non-treated with Restylane Volyme | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate on a Temple Hollowing Scale
A treatment responder is defined as a participant with at least a one-grade improvement from baseline on both temples concurrently on the Galderma Temple Volume Deficit Scale (GTVDS, a 4-grade scale rangings are none (0), mild (1), moderate (2), severe (3) temple hollowing) as assessed by the Blinded Evaluator at 6 months after last treatment for the Treatment group and 6 months after baseline for the Control group.
Measured: 6 months
Secondary outcomes (3)
Responder Rate on a Temple Hollowing Scale
A treatment responder is defined as a participant with at least a one-grade improvement from baseline on both temples concurrently on the Galderma Temple Volume Deficit Scale (GTVDS, a 4-grade scale rangings are none (0), mild (1), moderate (2), severe (3) temple hollowing). Assessed by Blinded Evaluator at 3, 9 and 12 months after last treatment for the Treatment group and at 3 months after baseline for the Control group.
Measured: 3, 9 and 12 months
Proportion of Participants Improved
Proportion of participants, defined by having at least "improved" (improved, much improved or very much improved) on the Global Aesthetic Improvement Scale (GAIS, with ratings are "Very much improved", "Much improved", "Improved", "No change" and "Worse"), on both sides of the face (each temple) concurrently, as assessed by the participant and the Treating Investigator, respectively, at 3, 6, 9 and 12 months after last treatment for the Treatment group.
Measured: 3, 6, 9 and 12 months
Proportion of Participants Improved
Proportion of participants, defined by having at least "improved" (improved, much improved or very much improved) on the GAIS (with ratings are "Very much improved", "Much improved", "Improved", "No change" and "Worse"), on both sides of the face (each temple) concurrently, as assessed by the participant and the Treating Investigator, respectively, at 3 and 6 months after optional treatment for the no-treatment Control group.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start18 Nov 2024
- Primary completion29 Apr 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temple 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
- 162 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
- NCT06665477
- Sponsor's protocol ID
- 43CH2401
- Status last verified
- Jun 2026
- First submitted
- 29 Oct 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 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 Volyme in the Treatment of Temple Hollowing
- ClinicalTrials.gov ID
- NCT06665477
- Acronym / sponsor ID
- 43CH2401
- Conditions
- Temple Hollowing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Volyme in the treatment 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 |
|---|---|---|
| Subject treated with Restylane Volyme | Experimental | Device: Restylane Volyme |
| Subject non-treated with Restylane Volyme | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study. Signed and dated informed consent to participate in the study.
- Males or non-pregnant, non-breastfeeding females of Chinese origin and 18 years of age or older at the time of signing the Informed Consent Form (ICF).
- Grade 2 (moderate) to 3 (severe) on the 4-grade GTVDS for both temples as assessed by the Blinded Evaluator as well as the Treating Investigator on Day 1 (agreement on grade is not required). The GTVDS grade for the right temple and the left temple does not have to be equal but must not differ by more than 1 grade.
- Willing to abstain from any other facial plastic surgical or cosmetic procedures above the level of the horizontal line from subnasale for the duration of the study (e.g., laser or chemical resurfacing, needling, facelift, lifting threads, radiofrequency etc.).
- Intent to undergo treatment for correction of temple hollowing.
Key exclusion criteria (39 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 or present severe or multiple allergies manifested by severe reactions, such as anaphylaxis or angioedema, or family history of these conditions.
- 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:
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 VolymeSubjects in Restylane Volyme treatment group will receive treatment on Day 1 and optiponal treatment 1 month later. | Device | Subject treated with Restylane Volyme |
Primary outcome
Responder Rate on a Temple Hollowing Scale
Time frame: 6 months
A treatment responder is defined as a participant with at least a one-grade improvement from baseline on both temples concurrently on the Galderma Temple Volume Deficit Scale (GTVDS, a 4-grade scale rangings are none (0), mild (1), moderate (2), severe (3) temple hollowing) as assessed by the Blinded Evaluator at 6 months after last treatment for the Treatment group and 6 months after baseline for the Control group.
3 secondary outcomes
Responder Rate on a Temple Hollowing Scale
Time frame: 3, 9 and 12 months
Proportion of Participants Improved
Time frame: 3, 6, 9 and 12 months
Proportion of Participants Improved
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Temple Hollowing
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Volyme in people with Temple Hollowing, run by Galderma R&D at 1 site in China.
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 14 inclusion and 39 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 11 Aug 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 on a Temple Hollowing Scale (time frame: 6 months). 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 11 Aug 2026.