Age-related Volume Deficit in the Mid-faceNCT01559064
The Volumizing Effect of Juvéderm VOLUMA® in the Mid-Face
An observational study of Age-related Volume Deficit in the Mid-face, run by Allergan Medical at 4 sites in 4 countries.
Trial summary
This is a prospective, observational study of the volumizing effect of aesthetic use of Juvéderm VOLUMA® with lidocaine in the mid-face area. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Volume Deficit in the Mid-face
- What is being tested?
- Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)
- Type of treatment
- Medical device
- How many people
- 115 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2012to Aug 2012
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal, healthy subjects desiring aesthetic improvement
Who may be able to join
- Desire and willingness for correction of asymmetry or enhancement of his/her mid-face area.
- Be willing to undergo treatment for volume loss in the face area
- Females and males ≥30 years of age
- Be in good health as of the opinion of the Investigator
- Sign the Informed Consent Form prior to any study-related procedures being performed
- Have established a realistic treatment goal that the Investigator agrees is achievable i.e., have realistic expectations of aesthetic results
Who cannot join
- Have extensive tissue damage that could affect the aesthetic outcome
- Have a known allergy to any component of VOLUMA® with lidocaine injections
- Have an abscess or infection at the time of treatment that in the opinion of the Investigator does not make the subject eligible for the procedure.
- Have undergone cosmetic facial [e.g., face-lift, or other surgeries, which may alter the appearance of the mid-face region (laser, photomodulation intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or meso-therapy] anywhere in the mid-face region, or Botox® Cosmetic injections in the lower face (below the orbital rim), within the 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with hyaluronic acid (HA) fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry
- Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
- Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein, or be planning to undergo a desensitization therapy during the term of the study
Show all 18Show fewer
- Suffer from an uncontrolled personality disorder (e.g., body dysmorphia, depression)
- Have a history of or currently suffer from an autoimmune disease (e.g., Rheumatoid arthritis, Crohn's disease)
- Have a history of streptococcal disease (e.g., strep throat or rheumatic fever with or without heart complications)
- Have a history of skin cancer
- Suffer from Porphyria
- Have epilepsy which is not controlled by anti-epilepsy therapy
- Current cutaneous inflammatory and/or infectious processes (e.g., acne, herpes, etc.)
- Have a history of treatment with interferon therapy (e.g., warfarin) or have taken non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or ginko biloba) within 10 days of undergoing study device injection. NOTE: Study device injection may be delayed as necessary to accommodate this 10-day washout period
- Be on a concurrent regimen of high doses of lidocaine (more than 400 mg) which may cause acute toxic reactions
- Be on a concurrent regimen of other local anesthetics structurally related to amide-type local anesthetics
- Have impaired cardiac conduction, severly impaired hepatic function, or severe renal dysfunction
- Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Prospective, Observational Study of the Volumizing Effect of Open-Label Aesthetic Use of VOLUMA® in the Mid-Face Area
This is a prospective, observational study of the volumizing effect of aesthetic use of Juvéderm VOLUMA® with lidocaine in the mid-face area.
- Being tested
- Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)Device
Also called Juvéderm VOLUMA® with lidocaine
All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
| Study group | Role | What they receive |
|---|---|---|
| Age group A | Subjects 30 to 40 years old Receives: Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) | |
| Age group B | Subjects 40 to 50 years old Receives: Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) | |
| Age group C | Subjects over 50 years old Receives: Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Experience Measured by Patient Satisfaction Questionnaire
Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionAug 2012
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 Age-related Volume Deficit in the Mid-faceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Allergan Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559064
- Sponsor's protocol ID
- MAF/AGN/MED/FIL/017
- Status last verified
- Jun 2014
- First submitted
- 19 Mar 2012
- Last updated
- 13 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Philipp-Dormston WG, Eccleston D, De Boulle K, Hilton S, van den Elzen H, Nathan M. A prospective, observational study of the volumizing effect of open-label aesthetic use of Juvederm(R) VOLUMA(R) with Lidocaine in mid-face area. J Cosmet Laser Ther. 2014 Aug;16(4):171-9. doi: 10.3109/14764172.2014.910079. Epub 2014 May 5.
PubMed 24689357
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study of the Volumizing Effect of Open-Label Aesthetic Use of VOLUMA® in the Mid-Face Area
- ClinicalTrials.gov ID
- NCT01559064
- Acronym / sponsor ID
- MAF/AGN/MED/FIL/017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Allergan MedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Posted 10 Jun 2013
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, observational study of the volumizing effect of aesthetic use of Juvéderm VOLUMA® with lidocaine in the mid-face area.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Age group A | – | Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)Subjects 30 to 40 years old |
| Age group B | – | Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)Subjects 40 to 50 years old |
| Age group C | – | Device: Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)Subjects over 50 years old |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal, healthy subjects desiring aesthetic improvement
Key inclusion criteria (6 listed)
- Desire and willingness for correction of asymmetry or enhancement of his/her mid-face area.
- Be willing to undergo treatment for volume loss in the face area
- Females and males ≥30 years of age
- Be in good health as of the opinion of the Investigator
- Sign the Informed Consent Form prior to any study-related procedures being performed
Key exclusion criteria (18 listed)
- Have extensive tissue damage that could affect the aesthetic outcome
- Have a known allergy to any component of VOLUMA® with lidocaine injections
- Have an abscess or infection at the time of treatment that in the opinion of the Investigator does not make the subject eligible for the procedure.
- Have undergone cosmetic facial [e.g., face-lift, or other surgeries, which may alter the appearance of the mid-face region (laser, photomodulation intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or meso-therapy] anywhere in the mid-face region, or Botox® Cosmetic injections in the lower face (below the orbital rim), within the 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with hyaluronic acid (HA) fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry
- Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
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 |
|---|---|---|
| Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)Also: Juvéderm VOLUMA® with lidocaineAll treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use. | Device | Age group A, Age group B, Age group C |
Primary outcome
Subject Experience Measured by Patient Satisfaction Questionnaire
Time frame: 3 weeks
Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24689357Philipp-Dormston WG, Eccleston D, De Boulle K, Hilton S, van den Elzen H, Nathan M. A prospective, observational study of the volumizing effect of open-label aesthetic use of Juvederm(R) VOLUMA(R) with Lidocaine in mid-face area. J Cosmet Laser Ther. 2014 Aug;16(4):171-9. doi: 10.3109/14764172.2014.910079. Epub 2014 May 5.
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 Monitor study director
Allergan Medical
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Volume Deficit in the Mid-face, run by Allergan Medical at 4 sites in 4 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 6 inclusion and 18 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 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Germany, Netherlands, United Kingdom. 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 10 Jun 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?
Subject Experience Measured by Patient Satisfaction Questionnaire (time frame: 3 weeks). 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 NCT01559064, 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 13 Oct 2014.