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

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.

Study Overview

• Status: Recruiting
• Conditions: Age-Related Volume Deficit in the Mid-Face
• Intervention / Treatment: Device: Algeness® DF 3.5%; Device: Juvéderm Voluma

• Study Type: Interventional
• Enrollment (Anticipated): 308
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HEATHER ASTLEY; Phone Number: 7813292993; Email: hastley@healthpolicyassociates.com

Study Locations

• Belgium
  • Oudenaarde, Belgium
    • Recruiting
    • J. Vandeputte, Plastische Chirurgie
    • Contact: Email: info@jvdp.be
• France
  • Antibes, France
    • Recruiting
    • MEDITI
  • Paris, France, 75016
    • Recruiting
    • THINKIN
• Germany
  • Darmstadt, Germany
    • Recruiting
    • Rosenpark Research GmbH
  • Munich, Germany
    • Recruiting
    • Private Practice for Dermatology and Aesthetics
• Israel
  • Zerifin, Israel
    • Recruiting
    • Shamir Medical Center
• Malaysia
  • Petaling Jaya, Malaysia
    • Not yet recruiting
    • Clique Clinic
    • Contact: Email: cliqueclinic.research@gmail.com
• Spain
  • Marbella, Spain
    • Recruiting
    • Beauty Beyond Skin (Ocean Clinic Marbella)
• United Arab Emirates
  • Dubai, United Arab Emirates
    • Recruiting
    • Galadari Derma Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Midface Scale Live Masked Evaluator All timepoints	Individual endpoints for change from baseline on the Midface Scale as rated by a live, 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
GAIS Live Masked Evaluator	GAIS Scores of Study Product and Comparator on Global Aesthetics Improvement Scale (GAIS) by live Masked Evaluator	1, 3, 9, 12, 18, 24 months
GAIS Investigator	GAIS Scores of Study Product and Comparator on Global Aesthetic Improvement Scale (GAIS) by Treating Investigator	1, 3, 9, 12, 18, 24 months
GAIS Patient	GAIS Scores of Study Product and Comparator on Global Aesthetic Improvement Scale (GAIS) by Patient	1, 3, 9, 12, 18, 24 months
Patient Reported FACE-Q	FACE-Q Satisfaction with Cheeks and Age Appraisal scales	1, 3, 9, 12, 18, 24 months
Treatment Duration	Duration of treatment effect as measured on the Midface Scale by ≥1 point improvement, for those subjects who did not receive retreatment prior to the assessment timepoint at months 18 and 24.	1, 3, 6, 9, 12, 18, 24 months
Midface Photo	treatment effect as measured on the Midface Scale by ≥1 point improvement as graded by a blinded photographic reviewer	1, 3, 6, 9, 12, 18, 24 months
Midface Photo Change from Baseline	Individual endpoint of change from baseline score on the Midface Scale as rated by blinded photographic reviewer	1, 3, 6, 9, 12, 18, 24 months

Collaborators and Investigators

• Sponsor: Advanced Aesthetic Technologies, Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AG35MF001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: All summary results will be posted to this website. Safety results will be shared with medical monitor and study physicians.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No