A Prospective Clinical Trial Evaluating the "Profile HIT" (Holistic Individualized Treatment)

Erevna Innovations Inc.1 site in 1 country18 target enrollmentMarch 20, 2023

ConditionsAesthetic

InterventionsRestylane line of injectables

DrugsRestylane line of injectables

Overview

Phase: N/A
Intervention: Restylane line of injectables
Conditions: Aesthetic
Sponsor: Erevna Innovations Inc.
Enrollment: 18
Locations: 1
Primary Endpoint: Primary Endpoint - Global Aesthetics Improvement Scale (GAIS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

March 20, 2023

End Date

March 24, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Erevna Innovations Inc.

Responsible Party

Principal Investigator

Andreas Nikolis

Principal Investigator

Erevna Innovations Inc.

Eligibility Criteria

Inclusion Criteria

•Subjects must voluntarily sign and date an informed consent, including the photography addendum allowing unrestricted use of photographs for the benefit of marketing 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 the protocol.
•Subjects must be in good health as per the investigator's judgment based on medical history
•Female subjects that are not pregnant or breastfeeding and are not considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of the study medical device or until the end of the study, whichever is longer.

Exclusion Criteria

•Subject with uncontrolled systemic disease.
•Subject with or have a history of any medical condition that may place the subject at increased risk following exposure to hyaluronic acid or interfere with the study evaluation, including:
•Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
•History of facial nerve palsy
•Infection or dermatological condition at the treatment injection sites
•Marked facial dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or overly photodamaged skin
•Subject with a history of clinically significant medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive the study medical intervention
•Subjects with a history of an allergic reaction or significant sensitivity to constituents of the study medical intervention (or its excipients).
•Subjects with porphyria
•Subjects with active diseases, such as inflammation, infection or tumours, in or near the intended treatment sites,

Arms & Interventions

Treatment

Intervention: Restylane line of injectables

Outcomes

Primary Outcomes

Primary Endpoint - Global Aesthetics Improvement Scale (GAIS)

Time Frame: At week 8

Frequency of subjects having at least "improved" (e.g., "improved", "much improved" or "very much improved") on the Global Aesthetics Improvement Scale (GAIS), as graded by a blinded evaluator.