Clinical trial NCT04892407: Algeness DF 3.5% Compared to Voluma in Volume Deficit in Mid-face
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age-Related Volume Deficit in the Mid-Face
Lead sponsor: Advanced Aesthetic Technologies, Inc
Sponsor class: INDUSTRY
First posted: 2021-05-19
Enrollment: 308
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: with ≥ 1 point improvement from baseline on Proprietary Midface Scale, a validated midface volume deficit scale as rated by a live, masked evaluator
timeFrame: 6 month
Secondary outcomes:
measure: 1+ grade Improvement on Midface Scale Live Masked Evaluator All timepoints
timeFrame: 1, 3, 9, 12, 18, 24 months
Other outcomes:
measure: Change From Baseline Midface Scale Live Masked Evaluator All timepoints
timeFrame: 1, 3, 9, 12, 18, 24 months
measure: GAIS Live Masked Evaluator
timeFrame: 1, 3, 9, 12, 18, 24 months
measure: GAIS Investigator
timeFrame: 1, 3, 9, 12, 18, 24 months
measure: GAIS Patient
timeFrame: 1, 3, 9, 12, 18, 24 months
measure: Patient Reported FACE-Q
timeFrame: 1, 3, 9, 12, 18, 24 months
measure: Treatment Duration
timeFrame: 1, 3, 6, 9, 12, 18, 24 months
measure: Midface Photo
timeFrame: 1, 3, 6, 9, 12, 18, 24 months
measure: Midface Photo Change from Baseline
timeFrame: 1, 3, 6, 9, 12, 18, 24 months
Locations:
city: Oudenaarde
country: Belgium
facility: J. Vandeputte, Plastische Chirurgie
city: Antibes
country: France
facility: MEDITI
city: Paris
country: France
facility: THINKIN
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
city: Munich
country: Germany
facility: Private Practice for Dermatology and Aesthetics
city: Zerifin
country: Israel
facility: Shamir Medical Center
city: Petaling Jaya
country: Malaysia
facility: Clique Clinic
city: Marbella
country: Spain
facility: Beauty Beyond Skin (Ocean Clinic Marbella)
city: Dubai
country: United Arab Emirates
facility: Galadari Derma Clinic
Study officials:
References: