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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-06

Study Completion Date

2024-08-31

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.

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Detailed Description

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Conditions

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Age-Related Volume Deficit in the Mid-Face

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The evaluator is blinded as to patient treatment. Patients are also not told what treatment they receive.

Study Groups

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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.

Group Type EXPERIMENTAL

Algeness® DF 3.5%

Intervention Type DEVICE

dermal filler CE Mark approved for treatment of cheek and midface volume loss

Juvéderm Voluma

This arm is with a Control product that is already CE Marked and sold for this indication.

Group Type ACTIVE_COMPARATOR

Juvéderm Voluma

Intervention Type DEVICE

dermal filler CE Mark approved for treatment of cheek and midface volume loss

Interventions

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Algeness® DF 3.5%

dermal filler CE Mark approved for treatment of cheek and midface volume loss

Intervention Type DEVICE

Juvéderm Voluma

dermal filler CE Mark approved for treatment of cheek and midface volume loss

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject is at least 22 years of age.
2. 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
3. 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).
4. Subject willing and able to comply with study follow-up procedures and schedule.
5. Subject willing to provide written informed consent for their participation in the study.

Exclusion Criteria

1. 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.
2. 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.
3. Subject is an employee or direct relative of an employee of the investigational site or Sponsor.
4. Subject who has received surgery in the mid-face (including mesh, or threads), or has plans to during the study.
5. 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).
6. 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.
7. Subject has a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
8. Subject has a history of precancerous lesions/skin malignancies.
9. Subject has had an active skin disease within the past 6 months.
10. Subject has scars, infection, rosacea, herpes, acne, blotches or other pathology on the mid-face.
11. Subject has facial hair in the mid-face that they are unwilling to remove for study assessments.
12. Subject is predisposed to keloidosis or hypertrophic scarring.
13. Subject has a known history of hyper- or hypo-pigmentation in the mid-face.
14. Subject has known allergy to agarose gel, algae, phosphate buffered saline, hyaluronic acid, gram positive bacterial proteins, streptococcal protein or lidocaine.
15. Subject has a known bleeding disorder.
16. 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.
17. 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).
18. 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)
19. 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).
20. 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.
21. 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.
22. 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.
23. Subject has a known history of or plans during the study rapid weight loss/gain (5% of body weight).

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes