Kiss and Smile HIT

March 28, 2024 updated by: Erevna Innovations Inc.

A Prospective Clinical Trial Evaluating the "Kiss and Smile HIT" (Holistic Individualized Treatment) Algorithm

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

The "Kiss and Smile HIT" considers lip volume, lip framing and expression to improve patients appearance. This trial will assess the effectiveness of the Kiss and Smile HIT algorithm in treating patients with different kiss and smile related issues (e.g. volume loss, lips lack proper framing, lack of a confident smile due to issues with expression).

Study Overview

Status

Recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Quebec
      • Montréal, Quebec, Canada, H3R3A1
        • Recruiting
        • Erevna Innovations Inc.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subjects must voluntarily sign and date an informed consent, including the photography addendum allowing unrestricted use of photographs for the use of marketing and educational purposes, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures.
  2. Subjects must at least 18 years old
  3. Male or female
  4. Subjects must be willing and able to comply with procedures required in the protocol
  5. Subjects must be in good health as per investigator's judgment based on medical history
  6. Female subjects of child-bearing potential must have a negative urine pregnancy test prior to any dose of study product
  7. Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control that is effective from Baseline through at least 30 days after the last dose or until the end of study, whichever is longer. Female subjects of nonchildbearing potential do not need to use birth control.

Exclusion Criteria:

  1. Uncontrolled systemic disease
  2. Subjects do not present 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 excessively photodamaged skin
  3. 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 study medical device
  4. History of an allergic reaction or significant sensitivity to constituents of the study medical device (or its excipients)
  5. Subject has tattoos, jewelry, or clothing which obscure temporal region and cannot be removed
  6. Subject has anticipated need for surgery or overnight hospitalization during the study.
  7. History of surgical procedures in the face including any lifting procedure (e.g., facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
  8. Subject has a history of facial treatment with semi- permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
  9. Subjects is presenting with porphyria
  10. Subjects has present with active disease, such as inflammation, infection or tumors, in or near the intended treatment sites
  11. Subject has bleeding disorders or take thrombolytics or anticoagulants
  12. Subjects has had known active COVID infection within 30 days of treatment
  13. Female subjects that are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer.
  14. Subjects has been treated with any investigational drug within 30 days prior to the first dose of study drug or is currently enrolled in another clinical study.
  15. Subject must take immunosuppressant medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Restylane Filler Line and Dysport Neuromodulator

This study will consist of an open-label, prospective, cohort trial design. Twenty-four subjects will be recruited.

Subjects will be recruited based on their primary deficit, 8 subjects will have a primary deficit in lip volume, 8 subjects will have a primary deficit in lip framing and 8 subjects will have a primary deficit in expression. All subjects will receive active treatment with hyaluronic acid at Baseline, with an optional touch at week two. There will be no placebo or no-treatment control groups. Subjects will be followed for five months.

Subjects will be treated with a range of hyaluronic acid based dermal fillers (Restylane line) and Dysport neuromodulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Aesthetic Improvement Scale (GAIS)
Time Frame: Baseline to Week 2, Week 4, Week 8, Week 20
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. Grading value varies from worse (grading of -1) to very much improved (grading of 3).
Baseline to Week 2, Week 4, Week 8, Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andreas Nikolis, MD, Erevna Innovations Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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