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

NCT04892407 | Unknown

• 1 other identifier: AG35MF001
• Study Type: interventional
• Target: 308
• Locations: 7 countries
• Sites: 9

Brief Summary

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

Conditions

Age-Related Volume Deficit in the Mid-Face

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 1+ grade Improvement on Midface Scale Live Masked Evaluator All timepoints

  1, 3, 9, 12, 18, 24 months

Other Outcomes (8)

• Change From Baseline Midface Scale Live Masked Evaluator All timepoints

  1, 3, 9, 12, 18, 24 months

• GAIS Live Masked Evaluator

  1, 3, 9, 12, 18, 24 months

• GAIS Investigator

  1, 3, 9, 12, 18, 24 months

Study Arms (2)

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.

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.

Device: Juvéderm Voluma

Interventions

Algeness® DF 3.5% DEVICE

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

Algeness DF 3.5%

Juvéderm Voluma DEVICE

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

Juvéderm Voluma

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Aesthetic Technologies, Inc: lead

Study Sites (9)

J. Vandeputte, Plastische Chirurgie

Oudenaarde, Belgium

RECRUITING

MEDITI

Antibes, France

RECRUITING

THINKIN

Paris, 75016, France

RECRUITING

Rosenpark Research GmbH

Darmstadt, Germany

RECRUITING

Private Practice for Dermatology and Aesthetics

Munich, Germany

RECRUITING

Shamir Medical Center

Ẕerifin, Israel

RECRUITING

Clique Clinic

Petaling Jaya, Malaysia

NOT YET RECRUITING

Beauty Beyond Skin (Ocean Clinic Marbella)

Marbella, Spain

RECRUITING

Galadari Derma Clinic

Dubai, United Arab Emirates

RECRUITING

Central Study Contacts

HEATHER ASTLEY

CONTACT

7813292993; hastley@healthpolicyassociates.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The evaluator is blinded as to patient treatment. Patients are also not told what treatment they receive.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: September 6, 2021
• Primary Completion: December 1, 2022
• Study Completion: August 1, 2024
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

AE (1); FR (2); IL (1); MY (1); DE (2); BE (1); ES (1)