Mid-face Volume DeficiencyNCT01029535

Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency

A study testing Cross-linked hyaluronic acid gel in people with Mid-face Volume Deficiency, run by Allergan at 1 site in Australia.

Completed

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

Official record

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Trial summary

This is a prospective, open-label experience study to be conducted at 6 clinical sites in Australia, with the objective to collect efficacy and safety information for Juvederm® VOLUMA™ when used for volumising the mid-face and cheek area. Read more about this study

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Mid-face Volume Deficiency
What is being tested?: Cross-linked hyaluronic acid gel
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 1 siteAustralia
Study dates: Jan 2009to Oct 2011
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 30 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects with mild to severe mid-face and cheek volume deficit due to age-related changes, who are likely to improve by at least 2 grades following treatment with the study compound, based on a study-specific scale, as assessed by the study physician

Who cannot join

Subjects who have a pre-existing medical condition or who have received any treatments or procedures which may impact on the assessment of the effects of the study compound.
Subjects with a history of allergies or other side effects to dermal fillers, lidocaine, hyaluronic acid or other component of the study compound.
Subjects were are pregnant or breast-feeding or who are of child-bearing potential and who are not prepared to practice an adequate form of contraception during the course of the study
Subjects with a history of alcoholism or drug abuse or dependence

Trial locations and contacts

1 site in 1 country.

Australia1 site

Study site
Sydney

Other trials in Australia

About this study

Conditions: Mid-face Volume Deficiency
Being tested: Cross-linked hyaluronic acid gel

What participants receive

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

Cross-linked hyaluronic acid gelDevice
Also called Juvederm® VOLUMA™
Cross-linked hyaluronic acid gel (Juvederm® VOLUMA™) up to 4 mLs injected in each side of the face.

Study groups in NCT01029535
Study group	Role	What they receive
Juvederm® VOLUMA™	Experimental	Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable. Receives: Device: Cross-linked hyaluronic acid gel

What is being measured

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

Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4
The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale where:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.
Measured: Baseline, Week 4
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8
The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.
Measured: Baseline, Week 8
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4
The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.
Measured: Baseline, Week 4
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8
The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.
Measured: Baseline, Week 8
Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4
The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.
Measured: Baseline, Week 4
Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8
The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.
Measured: Baseline, Week 8
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52
The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 52, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.
Measured: Baseline, Week 8, Week 52
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78
The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 78, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.
Measured: Baseline, Week 8, Week 78
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104
The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 104, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.
Measured: Baseline, Week 8, Week 104
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52
The participant rated their midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Measured: Baseline, Week 8, Week 52
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78
The participant rated their midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Measured: Baseline, Week 8, Week 78
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104
The participant rated their midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Measured: Baseline, Week 8, Week 104
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52
The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Measured: Baseline, Week 8, Week 52
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78
The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Measured: Baseline, Week 8, Week 78
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104
The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Measured: Baseline, Week 8, Week 104

Secondary outcomes (6)

Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
The physician assessed the left side and the right side of the participant's face for severity of nasolabial folds using the 5-point WAS where: 0=no wrinkle to 4=very deep wrinkle.
Measured: Baseline, Weeks 4, 8, 52, 78 and 104
Change From Baseline in the MFVDS Score
The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS where: 0=no facial volume loss to 5=severe volume loss. A negative change from Baseline indicates improvement.
Measured: Baseline, Weeks 4, 8, 52, 78 and 104
Physician Assessment of Global Aesthetic Improvement Score (GAIS)
The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.
Measured: Baseline, Weeks 4, 8, 52, 78 and 104
Subject's Assessment of Global Aesthetic Improvement Score (GAIS)
The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.
Measured: Baseline, Weeks 4, 8, 52, 78 and 104
Change From Baseline in the Subject's Self-Perception of Age (SPA)
The participant rated their facial age in years at Baseline and Weeks 4, 8, 52, 78 and 104. A negative change from Baseline indicates an improvement.
Measured: Baseline, Weeks 4, 8, 52, 78 and 104
Percentage of Participants Satisfied or Very Satisfied With the Treatment
Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied.
Measured: Week 8

Timeline

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

Jan 2009Oct 2011

First posted10 Dec 2009 (estimated)
Study startJan 2009
Primary completionApr 2011
Study completionOct 2011

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mid-face Volume DeficiencyStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01029535
Sponsor's protocol ID: VOL-AP01
Status last verified: Feb 2016
First submitted: 8 Dec 2009
Last updated: 9 Mar 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol. 2013 Mar 20;6:81-9. doi: 10.2147/CCID.S40581. Print 2013.
PubMed 23687448

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Clinical Investigation for Evaluating the Safety and Efficacy of JTM102 to Mid Face Volume Deficiency
Mid Face Volume Deficit
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
Not yet recruiting
Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)
Laxity; Skin, Volume Deficiency in the Mid-Face
Recruiting
A Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging
Volume Deficiency in the Mid-Face, Skin Laxity
Active, not recruiting
Clinical Investigation Evaluating the Safety and Feasibility of Adipearl
Mid-face Volume Deficiency

All Mid-face Volume Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency
ClinicalTrials.gov ID: NCT01029535
Acronym / sponsor ID: VOL-AP01
Conditions: Mid-face Volume Deficiency
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Apr 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 10 Dec 2009 (estimated)
Results: Posted 20 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Juvederm® VOLUMA™	Experimental	Device: Cross-linked hyaluronic acid gelJuvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Subjects with mild to severe mid-face and cheek volume deficit due to age-related changes, who are likely to improve by at least 2 grades following treatment with the study compound, based on a study-specific scale, as assessed by the study physician

Key exclusion criteria (4 listed)

Subjects who have a pre-existing medical condition or who have received any treatments or procedures which may impact on the assessment of the effects of the study compound.
Subjects with a history of allergies or other side effects to dermal fillers, lidocaine, hyaluronic acid or other component of the study compound.
Subjects were are pregnant or breast-feeding or who are of child-bearing potential and who are not prepared to practice an adequate form of contraception during the course of the study
Subjects with a history of alcoholism or drug abuse or dependence

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
Cross-linked hyaluronic acid gelAlso: Juvederm® VOLUMA™Cross-linked hyaluronic acid gel (Juvederm® VOLUMA™) up to 4 mLs injected in each side of the face.	Device	Juvederm® VOLUMA™

Primary outcome

Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4
Time frame: Baseline, Week 4
The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale where:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8
Time frame: Baseline, Week 8
The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4
Time frame: Baseline, Week 4
The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8
Time frame: Baseline, Week 8
The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.
Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4
Time frame: Baseline, Week 4
The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.
Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8
Time frame: Baseline, Week 8
The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52
Time frame: Baseline, Week 8, Week 52
The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 52, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78
Time frame: Baseline, Week 8, Week 78
The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 78, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104
Time frame: Baseline, Week 8, Week 104
The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 104, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52
Time frame: Baseline, Week 8, Week 52
The participant rated their midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78
Time frame: Baseline, Week 8, Week 78
The participant rated their midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104
Time frame: Baseline, Week 8, Week 104
The participant rated their midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52
Time frame: Baseline, Week 8, Week 52
The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78
Time frame: Baseline, Week 8, Week 78
The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104
Time frame: Baseline, Week 8, Week 104
The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.

6 secondary outcomes

Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
Time frame: Baseline, Weeks 4, 8, 52, 78 and 104
Change From Baseline in the MFVDS Score
Time frame: Baseline, Weeks 4, 8, 52, 78 and 104
Physician Assessment of Global Aesthetic Improvement Score (GAIS)
Time frame: Baseline, Weeks 4, 8, 52, 78 and 104
Subject's Assessment of Global Aesthetic Improvement Score (GAIS)
Time frame: Baseline, Weeks 4, 8, 52, 78 and 104
Change From Baseline in the Subject's Self-Perception of Age (SPA)
Time frame: Baseline, Weeks 4, 8, 52, 78 and 104
Percentage of Participants Satisfied or Very Satisfied With the Treatment
Time frame: Week 8

Results and safety

Results posted to the registry on 20 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Juvederm® VOLUMA™	103	72

Primary outcome: Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4

Time frame: Baseline, Week 4. Number. Unit: percentage of participants

Measure	Juvederm® VOLUMA™ n = 102
Value	97.06

Population analysed: Participants from the intent-to-treat (ITT) population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.

Primary outcome: Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8

Time frame: Baseline, Week 8. Number. Unit: percentage of participants

Measure	Juvederm® VOLUMA™ n = 99
Value	97.98

Population analysed: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.

Primary outcome: Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4

Time frame: Baseline, Week 4. Number. Unit: percentage of participants

Measure	Juvederm® VOLUMA™ n = 102
Value	100

Population analysed: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.

Primary outcome: Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8

Time frame: Baseline, Week 8. Number. Unit: percentage of particpants

Measure	Juvederm® VOLUMA™ n = 99
Value	100

Population analysed: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Juvederm® VOLUMA™_Phase 1	0 of 103 (0%)	65 of 103 (63.1%)	Not reported
Juvederm® VOLUMA™_Phase 2	1 of 99 (1%)	8 of 99 (8.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23687448Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol. 2013 Mar 20;6:81-9. doi: 10.2147/CCID.S40581. Print 2013.

Related trials for Mid-face Volume Deficiency

Active, not recruiting
Clinical Investigation for Evaluating the Safety and Efficacy of JTM102 to Mid Face Volume Deficiency
Mid Face Volume Deficit
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Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
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Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)
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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.

Medical Director study director

Allergan

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

Questions about this trial

What is this clinical trial studying?

A study testing Cross-linked hyaluronic acid gel in people with Mid-face Volume Deficiency, run by Allergan at 1 site in Australia.

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 1 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 9 Mar 2016. 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 Australia. 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 20 Feb 2013). 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 a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4 (time frame: Baseline, Week 4). The study lists 15 primary outcomes in all. 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 NCT01029535, which also lists 1 linked publication.

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 9 Mar 2016.