UnknownNot Applicable

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

Belgium, France, Germany308 participantsStarted 2021-09-06

Plain-language summary

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

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

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

NCT IDNCT04892407

SponsorAdvanced Aesthetic Technologies, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12

HEATHER ASTLEY

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.