AestheticPhase 4NCT06336785
Kiss and Smile HIT (Holistic Individualized Treatment)
A Phase 4 study testing Restylane line of soft tissue fillers and Dysport neuromodulator in people with Aesthetic, run by Erevna Innovations Inc. at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aesthetic
- What is being tested?
- Restylane line of soft tissue fillers and Dysport neuromodulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 2 Nov 2023to 30 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Subjects must at least 18 years old
- Male or female
- Subjects must be willing and able to comply with procedures required in the protocol
- Subjects must be in good health as per investigator's judgment based on medical history
- Female subjects of child-bearing potential must have a negative urine pregnancy test prior to any dose of study product
- 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.
Who cannot join
- Uncontrolled systemic disease
- 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
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- 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
- History of an allergic reaction or significant sensitivity to constituents of the study medical device (or its excipients)
- Subject has tattoos, jewelry, or clothing which obscure temporal region and cannot be removed
- Subject has anticipated need for surgery or overnight hospitalization during the study.
- 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).
- 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.
- Subjects is presenting with porphyria
- Subjects has present with active disease, such as inflammation, infection or tumors, in or near the intended treatment sites
- Subject has bleeding disorders or take thrombolytics or anticoagulants
- Subjects has had known active COVID infection within 30 days of treatment
- 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.
- 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.
- Subject must take immunosuppressant medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Aesthetic
- Being tested
- Restylane line of soft tissue fillers and Dysport neuromodulator
- Keywords
- Hyaluronic Acid, Aesthetic Injection, Holistic Individualized Treatment, Perioral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane line of soft tissue fillers and Dysport neuromodulatorDevice
Subjects will be treated with a range of hyaluronic acid-based soft tissue fillers (Restylane line) and Dysport neuromodulator
| Study group | Role | What they receive |
|---|---|---|
| Restylane Filler Line and Dysport Neuromodulator | Experimental | 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. Receives: Device: Restylane line of soft tissue fillers and Dysport neuromodulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Aesthetic Improvement Scale (GAIS)
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).
Measured: Baseline to Week 2, Week 4, Week 8, Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start2 Nov 2023
- Primary completion30 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AestheticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Nikolis, MD, Principal investigator, Erevna Innovations Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336785
- Sponsor's protocol ID
- 04-2023-HIT-K&S
- Status last verified
- Feb 2025
- First submitted
- 22 Mar 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Trial Evaluating the "Kiss and Smile HIT" (Holistic Individualized Treatment) Algorithm
- ClinicalTrials.gov ID
- NCT06336785
- Acronym / sponsor ID
- 04-2023-HIT-K&S
- Conditions
- Aesthetic
- Keywords
- Hyaluronic Acid, Aesthetic Injection, Holistic Individualized Treatment, Perioral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restylane Filler Line and Dysport Neuromodulator | Experimental | Device: Restylane line of soft tissue fillers and Dysport neuromodulatorThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Subjects must at least 18 years old
- Male or female
- Subjects must be willing and able to comply with procedures required in the protocol
- Subjects must be in good health as per investigator's judgment based on medical history
Key exclusion criteria (19 listed)
- Uncontrolled systemic disease
- 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:
- 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
- History of an allergic reaction or significant sensitivity to constituents of the study medical device (or its excipients)
- Subject has tattoos, jewelry, or clothing which obscure temporal region and cannot be removed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restylane line of soft tissue fillers and Dysport neuromodulatorSubjects will be treated with a range of hyaluronic acid-based soft tissue fillers (Restylane line) and Dysport neuromodulator | Device | Restylane Filler Line and Dysport Neuromodulator |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Nikolis, MD principal investigator
Erevna Innovations Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Restylane line of soft tissue fillers and Dysport neuromodulator in people with Aesthetic, run by Erevna Innovations Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Aesthetic Improvement Scale (GAIS) (time frame: Baseline to Week 2, Week 4, Week 8, Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.