Temple HollowingPhase 3NCT04414397
A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old
A Phase 3 study testing JUVÉDERM® VOLUMA® XC in people with Temple Hollowing, run by Allergan at 15 sites in 2 countries.
Trial summary
The objectives of this study are to evaluate the safety and effectiveness of Juvederm® Voluma® XC injectable gel in adult participants seeking correction of temple hollowing Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Temple Hollowing
- What is being tested?
- JUVÉDERM® VOLUMA® XC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 28 May 2020to 17 Oct 2022
- Phase
- Phase 3
- 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
- Participants in general good health
- Participants seeking improvement of temple hollowing
Who cannot join
- Temple hollowing due to trauma, congenital malformations, or lipodystrophy
- Temporomandibular joint dysfunction or any other jaw issues
- Recurrent temporal headaches such as temporal tendinitis migraine
- Active autoimmune disease
- History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
- Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area (eg, biopsy)
Show all 12Show fewer
- Fat injection or permanent facial implants anywhere in the face
- Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months before enrollment
- Temporary dermal filler injections above the subnasale within 24 months before enrollment
- Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment
- Botulinum toxin treatment above the subnasale within 6 months before enrollment
- Females who are pregnant, nursing, or planning a pregnancy
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
Steven Fagien MD PA /ID# 232807
Boca Raton, Florida, 33431
Bradenton Dermatologist /ID# 232822
Bradenton, Florida, 34209
Aesthetic Solutions /ID# 232953
Chapel Hill, North Carolina, 27517-9901
Skincare Physicians /ID# 233054
Chestnut Hill, Massachusetts, 02467
Hevia Cosmetic Dermatology /ID# 232824
Coral Gables, Florida, 33134
Dallas Plastic Surgery Institute /ID# 232971
Dallas, Texas, 75231
Callender Center for Clinical Research /ID# 233167
Glenn Dale, Maryland, 20769-9182
Williams Plastic Surgery Specialists /ID# 232789
Latham, New York, 12110
Skin Care and Laser Physicians of Beverly Hills /ID# 232967
Los Angeles, California, 90069
Skin and Cancer Associates, LLP /ID# 232923
Miami, Florida, 33137-3254
The Practice of Brian S. Biesman MD PLLC /ID# 232662
Nashville, Tennessee, 37203
Delricht Research /ID# 233142
New Orleans, Louisiana, 70115
Steve Yoelin MD Medical Associate Inc /ID# 232956
Newport Beach, California, 92663
Research Institute of the Southeast, LLC /ID# 233144
West Palm Beach, Florida, 33401-2712
Puerto Rico1 site
Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 232706
San Juan, 00917
About this study
Official title: A Multicenter, Evaluator-blinded, Randomized, Parallel-group, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing
The objectives of this study are to evaluate the safety and effectiveness of Juvederm® Voluma® XC injectable gel in adult participants seeking correction of temple hollowing
- Conditions
- Temple Hollowing
- Being tested
- JUVÉDERM® VOLUMA® XC, No-treatment control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUVÉDERM® VOLUMA® XCDevice
JUVÉDERM® VOLUMA® XC injectable gel
No-treatment controlOther
Participants received no treatment for 3 months during the Control Period.
| Study group | Role | What they receive |
|---|---|---|
| No Treatment then JUVÉDERM® VOLUMA® XC | Other | Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period. Receives: Device: JUVÉDERM® VOLUMA® XC; Other: No-treatment control |
| JUVÉDERM® VOLUMA® XC | Experimental | Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period. Receives: Device: JUVÉDERM® VOLUMA® XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3
The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
Measured: Baseline, Month 3 (Control Period)
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product.
Measured: From the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment
Secondary outcomes (4)
Percentage of Participants With a Score of "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3
The Evaluating Investigator assessed the participant's temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Measured: Month 3 (Control Period)
Percentage of Participants With a Score of "Improved" or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3
Participants assessed their temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Measured: Month 3 (Control Period)
Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3
The participants responded to each item on the FACE-Q Satisfaction with Facial Appearance questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, and 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.
Measured: Baseline, Month 3 (Control Period)
Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire
The participants responded to each item on the FACE-Q Satisfaction with Temples questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.
Measured: Baseline, Month 3 (Control Period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start28 May 2020
- Primary completion17 Oct 2022
- Study completion17 Oct 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 Temple HollowingStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN, INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414397
- Sponsor's protocol ID
- 1878-702-008
- Status last verified
- Mar 2024
- First submitted
- 29 May 2020
- Last updated
- 25 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Evaluator-blinded, Randomized, Parallel-group, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing
- ClinicalTrials.gov ID
- NCT04414397
- Acronym / sponsor ID
- 1878-702-008
- Conditions
- Temple Hollowing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 28 May 2020 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 25 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to evaluate the safety and effectiveness of Juvederm® Voluma® XC injectable gel in adult participants seeking 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 |
|---|---|---|
| No Treatment then JUVÉDERM® VOLUMA® XC | Other | Device: JUVÉDERM® VOLUMA® XC, Other: No-treatment controlParticipants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period. |
| JUVÉDERM® VOLUMA® XC | Experimental | Device: JUVÉDERM® VOLUMA® XCParticipants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants in general good health
- Participants seeking improvement of temple hollowing
Key exclusion criteria (12 listed)
- Temple hollowing due to trauma, congenital malformations, or lipodystrophy
- Temporomandibular joint dysfunction or any other jaw issues
- Recurrent temporal headaches such as temporal tendinitis migraine
- Active autoimmune disease
- History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
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 |
|---|---|---|
| JUVÉDERM® VOLUMA® XCJUVÉDERM® VOLUMA® XC injectable gel | Device | JUVÉDERM® VOLUMA® XC, No Treatment then JUVÉDERM® VOLUMA® XC |
| No-treatment controlParticipants received no treatment for 3 months during the Control Period. | Other | No Treatment then JUVÉDERM® VOLUMA® XC |
Primary outcome
Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3
Time frame: Baseline, Month 3 (Control Period)
The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
Number of Participants With Adverse Events
Time frame: From the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product.
4 secondary outcomes
Percentage of Participants With a Score of "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3
Time frame: Month 3 (Control Period)
Percentage of Participants With a Score of "Improved" or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3
Time frame: Month 3 (Control Period)
Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3
Time frame: Baseline, Month 3 (Control Period)
Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire
Time frame: Baseline, Month 3 (Control Period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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.
ALLERGAN, INC. study director
Allergan
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JUVÉDERM® VOLUMA® XC in people with Temple Hollowing, run by Allergan at 15 sites in 2 countries.
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 12 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 2024. 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, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Apr 2024). 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?
Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3 (time frame: Baseline, Month 3 (Control Period)). The study lists 2 primary outcomes in all. 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 2024.