Algeness DF 3.5% Compared to Voluma in Volume Deficit in Mid-face

Study Overview
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Brief Summary
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A prospective, randomized, controlled study of Algeness® DF 3.5% Deep Volumizing Filler comparing to Juvéderm Voluma to correct midface volume loss.

Official Title
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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

Conditions
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Age-Related Volume Deficit in the Mid-Face

Intervention / Treatment
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* Device: Algeness® DF 3.5%
* Device: Juvéderm Voluma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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).

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Algeness DF 3.5%<br>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. | Device: Algeness® DF 3.5%<br>* dermal filler CE Mark approved for treatment of cheek and midface volume loss<br>|
| Active Comparator: Juvéderm Voluma<br>This arm is with a Control product that is already CE Marked and sold for this indication. | Device: Juvéderm Voluma<br>* dermal filler CE Mark approved for treatment of cheek and midface volume loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 1, 3, 9, 12, 18, 24 months |