Last updated: June 24, 2022
Sponsor: Advanced Aesthetic Technologies, Inc
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT04892407
AG35MF001
Ages > 22 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject is at least 22 years of age.
- Subject has moderate to severe age-related volume deficit in the midface on both sidesof the face as rated on LifeSprout Midface Scale, a proprietary, validated mid-facevolume deficit scale
- Subject willing to abstain from other facial aesthetic procedures in the mid-facethrough 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, otherfacial 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 thestudy.
Exclusion
Exclusion Criteria:
- Subject is a female of childbearing potential (e.g., not postmenopausal for at leastone year or has not had a hysterectomy or tubal ligation) not using medicallyeffective birth control (e.g., hormonal methods in use at least 30 days prior toinjection or barrier methods such as condom and spermicide in use at least 14 daysprior to injection) or is pregnant, lactating, or plans to become pregnant during thestudy.
- Subject has participated in a clinical study in which an investigational device ordrug was received in the 30 days prior to screening or plans to enroll in such a studyduring the course of the current study.
- Subject is an employee or direct relative of an employee of the investigational siteor Sponsor.
- Subject who has received surgery in the mid-face (including mesh, or threads), or hasplans 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 orrecurrent infection or inflammation with the potential to interfere with the studyresults or increase the risk of adverse events.
- Subject has a disorder that may impact wound healing such as connective tissue orimmunosuppressive 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 onthe mid-face.
- Subject has facial hair in the mid-face that they are unwilling to remove for studyassessments.
- 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, hyaluronicacid, 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 upto 1 month after any treatment high-dose Vitamin E, aspirin, anti-inflammatories,antiplatelets, thrombolytics, or any other medication that could increase the risk ofbleeding.
- Subject has received within the past 3 months or plans to receive during the studychemotherapy agents, immunosuppressive medications, or systemic corticosteroids (inhaled steroids are acceptable).
- Subject has received within the past 12 months or plans to receive during the studyany 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 studyneurotoxin on the face below the orbital rim (forehead is acceptable).
- Subject has received at any time or plans to receive during the study a permanentfiller (e.g., polylactic acid, PMMA, silicone) on the face.
- Subject has received within the past 6 months or plans to receive during the studydermal resurfacing procedures or non-invasive skin tightening on the face.
- Subject has received in the past 4 weeks or plans to receive during the studyprescription facial wrinkle therapies (RENOVA), topical steroids, skin irritatingtopical preparations, or self-tanning agents on the face.
- Subject has a known history of or plans during the study rapid weight loss/gain (5% ofbody weight).
Study Design
Total Participants: 308
Study Start date:
September 06, 2021
Estimated Completion Date:
August 31, 2024
Connect with a study center
J. Vandeputte, Plastische Chirurgie
Oudenaarde,
BelgiumActive - Recruiting
MEDITI
Antibes,
FranceActive - Recruiting
THINKIN
Paris, 75016
FranceActive - Recruiting
Rosenpark Research GmbH
Darmstadt,
GermanyActive - Recruiting
Private Practice for Dermatology and Aesthetics
Munich,
GermanyActive - Recruiting
Shamir Medical Center
Zerifin,
IsraelActive - Recruiting
Clique Clinic
Petaling Jaya,
MalaysiaSite Not Available
Beauty Beyond Skin (Ocean Clinic Marbella)
Marbella,
SpainActive - Recruiting
Galadari Derma Clinic
Dubai,
United Arab EmiratesActive - Recruiting
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