Age-Related Volume Deficit in the Mid-FaceNCT04892407
Algeness DF 3.5% Compared to Voluma in Volume Deficit in Mid-face
A study testing Algeness® DF 3.5% and Juvéderm Voluma in people with Age-Related Volume Deficit in the Mid-Face, run by Advanced Aesthetic Technologies, Inc at 9 sites in 7 countries.
Trial summary
A prospective, randomized, controlled study of Algeness® DF 3.5% Deep Volumizing Filler comparing to Juvéderm Voluma to correct midface volume loss. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Volume Deficit in the Mid-Face
- What is being tested?
- Algeness® DF 3.5% and Juvéderm Voluma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 9 sitesin 7 countries
- Study dates
- 6 Sep 2021to Aug 2024
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is at least 22 years of age.
- Subject has moderate to severe age-related volume deficit in the midface on both sides of the face as rated on LifeSprout Midface Scale, a proprietary, validated mid-face volume deficit scale
- Subject willing to abstain from other facial aesthetic procedures in the mid-face through the last study follow-up visit which could interfere with treatment outcomes (e.g., facial fillers, skin laser and radiofrequency therapy such as Thermage, chemical re-surfacing, dermabrasion, Botox injections, aesthetic facial surgery, other facial treatments of the mid-face).
- Subject willing and able to comply with study follow-up procedures and schedule.
- Subject willing to provide written informed consent for their participation in the study.
Who cannot join
- Subject is a female of childbearing potential (e.g., not postmenopausal for at least one year or has not had a hysterectomy or tubal ligation) not using medically effective birth control (e.g., hormonal methods in use at least 30 days prior to injection or barrier methods such as condom and spermicide in use at least 14 days prior to injection) or is pregnant, lactating, or plans to become pregnant during the study.
- Subject has participated in a clinical study in which an investigational device or drug was received in the 30 days prior to screening or plans to enroll in such a study during the course of the current study.
- Subject is an employee or direct relative of an employee of the investigational site or Sponsor.
- Subject who has received surgery in the mid-face (including mesh, or threads), or has plans to during the study.
- Subject has a serious or progressive disease, which, in the investigator's judgment, put the subject at undue risk (e.g., uncontrolled diabetes, autoimmune pathology, cardiac pathologies).
- Subject has an acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
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- Subject has a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
- Subject has a history of precancerous lesions/skin malignancies.
- Subject has had an active skin disease within the past 6 months.
- Subject has scars, infection, rosacea, herpes, acne, blotches or other pathology on the mid-face.
- Subject has facial hair in the mid-face that they are unwilling to remove for study assessments.
- Subject is predisposed to keloidosis or hypertrophic scarring.
- Subject has a known history of hyper- or hypo-pigmentation in the mid-face.
- Subject has known allergy to agarose gel, algae, phosphate buffered saline, hyaluronic acid, gram positive bacterial proteins, streptococcal protein or lidocaine.
- Subject has a known bleeding disorder.
- Subject has received within the past week or plans to receive with 1 week before or up to 1 month after any treatment high-dose Vitamin E, aspirin, anti-inflammatories, antiplatelets, thrombolytics, or any other medication that could increase the risk of bleeding.
- Subject has received within the past 3 months or plans to receive during the study chemotherapy agents, immunosuppressive medications, or systemic corticosteroids (inhaled steroids are acceptable).
- Subject has received within the past 12 months or plans to receive during the study any injections outside of those in the study protocol including non-permanent fillers (e.g., hyaluronic acid, CaHA)
- Subject has received within the past 12 months or plans to receive during the study neurotoxin on the face below the orbital rim (forehead is acceptable).
- Subject has received at any time or plans to receive during the study a permanent filler (e.g., polylactic acid, PMMA, silicone) on the face.
- Subject has received within the past 6 months or plans to receive during the study dermal resurfacing procedures or non-invasive skin tightening on the face.
- Subject has received in the past 4 weeks or plans to receive during the study prescription facial wrinkle therapies (RENOVA), topical steroids, skin irritating topical preparations, or self-tanning agents on the face.
- Subject has a known history of or plans during the study rapid weight loss/gain (5% of body weight).
Trial locations and contacts
9 sites in 7 countries.
9 sites in 7 countries
France2 sites, 2 recruiting
- Recruiting
MEDITI
Antibes
- Recruiting
THINKIN
Paris, 75016
Germany2 sites, 2 recruiting
- Recruiting
Rosenpark Research GmbH
Darmstadt
- Recruiting
Private Practice for Dermatology and Aesthetics
Munich
Belgium1 site, 1 recruiting
- Recruiting
J. Vandeputte, Plastische Chirurgie
Oudenaarde
info@jvdp.be
Malaysia1 site, 1 recruiting
- Not yet recruiting
Clique Clinic
Petaling Jaya
cliqueclinic.research@gmail.com
Spain1 site, 1 recruiting
- Recruiting
Beauty Beyond Skin (Ocean Clinic Marbella)
Marbella
United Arab Emirates1 site, 1 recruiting
- Recruiting
Galadari Derma Clinic
Dubai
About this study
Official title: A Prospective, Multi-center, Randomized, Controlled, Single-blind Study of the Safety and Effectiveness of Algeness® DF 3.5% Deep Volumizing Filler to Correct Age-related Volume Deficit in the Mid-face
A prospective, randomized, controlled study of Algeness® DF 3.5% Deep Volumizing Filler comparing to Juvéderm Voluma to correct midface volume loss.
- Being tested
- Algeness® DF 3.5%, Juvéderm Voluma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algeness® DF 3.5%Device
dermal filler CE Mark approved for treatment of cheek and midface volume loss
Juvéderm VolumaDevice
dermal filler CE Mark approved for treatment of cheek and midface volume loss
| Study group | Role | What they receive |
|---|---|---|
| Algeness DF 3.5% | Experimental | This arm is with the Sponsor's product. The product is already CE Marked and sold for this indication for the majority of participating countries. Receives: Device: Algeness® DF 3.5% |
| Juvéderm Voluma | Active comparator | This arm is with a Control product that is already CE Marked and sold for this indication. Receives: Device: Juvéderm Voluma |
What is being measured
The primary outcome is the main question the study is designed to answer.
with ≥ 1 point improvement from baseline on Proprietary Midface Scale, a validated midface volume deficit scale as rated by a live, masked evaluator
Statistical non inferiority of Study Product to Control by live Masked Evaluator of Subjects showing atleast a 1 point improvement. LifeSprout Midface Scale (0-4 with 0 being best and 4 being the worst/most extreme)
Measured: 6 month
Secondary outcomes (1)
1+ grade Improvement on Midface Scale Live Masked Evaluator All timepoints
1+ grade improvement from baseline in midface scale by masked evaluator. LifeSprout Midface Scale (0-4 with 0 being best and 4 being the worst/most extreme)
Measured: 1, 3, 9, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start6 Sep 2021
- Primary completionDec 2022 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3:1 randomization to either study product or comparator. If subject loses volume in cheek and/or returns to baseline score at or after 12month visit, he/she may be treated with study product.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Aesthetic Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892407
- Sponsor's protocol ID
- AG35MF001
- Status last verified
- Jun 2022
- First submitted
- 14 May 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All summary results will be posted to this website. Safety results will be shared with medical monitor and study physicians.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Controlled, Single-blind Study of the Safety and Effectiveness of Algeness® DF 3.5% Deep Volumizing Filler to Correct Age-related Volume Deficit in the Mid-face
- ClinicalTrials.gov ID
- NCT04892407
- Acronym / sponsor ID
- AG35MF001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Advanced Aesthetic Technologies, IncIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 19 May 2021 (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 prospective, randomized, controlled study of Algeness® DF 3.5% Deep Volumizing Filler comparing to Juvéderm Voluma to correct midface volume loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 3:1 randomization to either study product or comparator. If subject loses volume in cheek and/or returns to baseline score at or after 12month visit, he/she may be treated with study product.
| Arm | Type | Receives |
|---|---|---|
| Algeness DF 3.5% | Experimental | Device: Algeness® DF 3.5%This arm is with the Sponsor's product. The product is already CE Marked and sold for this indication for the majority of participating countries. |
| Juvéderm Voluma | Active comparator | Device: Juvéderm VolumaThis arm is with a Control product that is already CE Marked and sold for this indication. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is at least 22 years of age.
- Subject has moderate to severe age-related volume deficit in the midface on both sides of the face as rated on LifeSprout Midface Scale, a proprietary, validated mid-face volume deficit scale
- Subject willing to abstain from other facial aesthetic procedures in the mid-face through the last study follow-up visit which could interfere with treatment outcomes (e.g., facial fillers, skin laser and radiofrequency therapy such as Thermage, chemical re-surfacing, dermabrasion, Botox injections, aesthetic facial surgery, other facial treatments of the mid-face).
- Subject willing and able to comply with study follow-up procedures and schedule.
- Subject willing to provide written informed consent for their participation in the study.
Key exclusion criteria (23 listed)
- Subject is a female of childbearing potential (e.g., not postmenopausal for at least one year or has not had a hysterectomy or tubal ligation) not using medically effective birth control (e.g., hormonal methods in use at least 30 days prior to injection or barrier methods such as condom and spermicide in use at least 14 days prior to injection) or is pregnant, lactating, or plans to become pregnant during the study.
- Subject has participated in a clinical study in which an investigational device or drug was received in the 30 days prior to screening or plans to enroll in such a study during the course of the current study.
- Subject is an employee or direct relative of an employee of the investigational site or Sponsor.
- Subject who has received surgery in the mid-face (including mesh, or threads), or has plans to during the study.
- Subject has a serious or progressive disease, which, in the investigator's judgment, put the subject at undue risk (e.g., uncontrolled diabetes, autoimmune pathology, cardiac pathologies).
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 |
|---|---|---|
| Algeness® DF 3.5%dermal filler CE Mark approved for treatment of cheek and midface volume loss | Device | Algeness DF 3.5% |
| Juvéderm Volumadermal filler CE Mark approved for treatment of cheek and midface volume loss | Device | Juvéderm Voluma |
Primary outcome
with ≥ 1 point improvement from baseline on Proprietary Midface Scale, a validated midface volume deficit scale as rated by a live, masked evaluator
Time frame: 6 month
Statistical non inferiority of Study Product to Control by live Masked Evaluator of Subjects showing atleast a 1 point improvement. LifeSprout Midface Scale (0-4 with 0 being best and 4 being the worst/most extreme)
1 secondary outcome
1+ grade Improvement on Midface Scale Live Masked Evaluator All timepoints
Time frame: 1, 3, 9, 12, 18, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: Undecided. All summary results will be posted to this website. Safety results will be shared with medical monitor and study physicians.
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.
9 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algeness® DF 3.5% and Juvéderm Voluma in people with Age-Related Volume Deficit in the Mid-Face, run by Advanced Aesthetic Technologies, Inc at 9 sites in 7 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 5 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Germany, Belgium, Israel, Malaysia and 2 more countries. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HEATHER ASTLEY (7813292993, hastley@healthpolicyassociates.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
with ≥ 1 point improvement from baseline on Proprietary Midface Scale, a validated midface volume deficit scale as rated by a live, masked evaluator (time frame: 6 month). 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 27 Jun 2022.