"Profile HIT" (Holistic Individualized Treatment)

Last updated: February 3, 2025
Sponsor: Erevna Innovations Inc.
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Restylane line of injectable

Restylane line of injectables

Clinical Study ID

NCT05819502
02-2023-HIT-PRF
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The "Holistic Individualized Treatment" (HIT) approach is used to identify treatment priorities, focus areas, and appropriate products for soft tissue filler treatments.

The "Profile HIT" considers the balance between the midface, nose, lips, and chin to improve a patient's appearance. This trial will assess the effectiveness of the Profile HIT algorithm in treating patients with different profile issues (e.g. nasal deformities, volume loss, chin retrusion).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must voluntarily sign and date an informed consent, including thephotography addendum allowing unrestricted use of photographs for the benefit ofmarketing and educational purposes, approved by an independent ethics committee,before the initiation of any screening or study-specific procedures.

  • Subjects must be adult male or female, at least 18 years old.

  • Subjects must be willing and able to comply with procedures required in theprotocol.

  • Subjects must be in good health as per the investigator's judgment based on medicalhistory

  • Female subjects that are not pregnant or breastfeeding and are not consideringbecoming pregnant or donating eggs during the study or for approximately 30 daysafter the last dose of the study medical device or until the end of the study,whichever is longer.

Exclusion

Exclusion Criteria:

  • Subject with uncontrolled systemic disease.

  • Subject with or have a history of any medical condition that may place the subjectat increased risk following exposure to hyaluronic acid or interfere with the studyevaluation, including:

  • Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateralsclerosis, or any other significant disease that might interfere withneuromuscular function

  • History of facial nerve palsy

  • Infection or dermatological condition at the treatment injection sites

  • Marked facial dermatochalasis, deep dermal scarring, excessively thicksebaceous skin, or overly photodamaged skin

  • Subject with a history of clinically significant medical conditions or any otherreason that the investigator determines would interfere with the subject'sparticipation in this study or would make the subject an unsuitable candidate toreceive the study medical intervention

  • Subjects with a history of an allergic reaction or significant sensitivity toconstituents of the study medical intervention (or its excipients).

  • Subjects with porphyria

  • Subjects with active diseases, such as inflammation, infection or tumours, in ornear the intended treatment sites,

  • Subjects with bleeding disorders or taking thrombolytics or anticoagulants.

  • Subjects who need to take immunosuppressants.

  • Subjects with tattoos, jewelry, or clothing which obscure the treatment area andcannot be removed.

  • Subjects who have anticipated the need for surgery or overnight hospitalizationduring the study.

  • Subjects with a history of surgical procedures in the face, including any liftingmethod (e.g., facial lift, suture lift, thread lift, brow lift, eyelid and eyebrowsurgery).

  • Subjects with a history of facial treatment with semi-permanent or permanent softtissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate,polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fattransplantation.

  • Subjects with known active COVID infection within 14 days of baseline treatment.

  • Subjects that have been treated with any investigational product within 30 daysbefore the first dose of the study medical device or are currently enrolled inanother clinical study

Study Design

Total Participants: 18
Treatment Group(s): 2
Primary Treatment: Restylane line of injectable
Phase:
Study Start date:
March 20, 2023
Estimated Completion Date:
March 24, 2024

Connect with a study center

  • Erevna Innovations Inc

    Montreal, Quebec H3R 3A1
    Canada

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.