AestheticHIT-PRFNCT05819502
"Profile HIT" (Holistic Individualized Treatment)
A study testing Restylane line of injectables 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 "Profile HIT" considers the balance between the midface, nose, lips, and chin to improve a patient's 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 injectables
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 20 Mar 2023to 24 Mar 2024
- Phase
- Interventional
- 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 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.
Who cannot join
- 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
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- 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,
- 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 and cannot be removed.
- Subjects who have anticipated the need for surgery or overnight hospitalization during the study.
- Subjects with a history of surgical procedures in the face, including any lifting method (e.g., facial lift, suture lift, thread lift, brow lift, eyelid and eyebrow surgery).
- Subjects with 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 with known active COVID infection within 14 days of baseline treatment.
- Subjects that have been treated with any investigational product within 30 days before the first dose of the study medical device or are currently enrolled in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Clinical Trial Evaluating the "Profile HIT" (Holistic Individualized Treatment)
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).
- Conditions
- Aesthetic
- Being tested
- Restylane line of injectables
- Keywords
- Hyaluronic acid, Fillers, Volumization, Facial Profile, Patient Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane line of injectablesDrug
Restylane fillers are manufactured by Q-Med AB, part of the Galderma Group.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Restylane line of injectables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint - Global Aesthetics 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.
Measured: At week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start20 Mar 2023
- Primary completion24 Feb 2024
- Study completion24 Mar 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will consist of an open-label, prospective, cohort trial design. Eighteen subjects will be recruited. Subjects will be recruited based on their primary deficit, where all subjects must have a mild or greater deficit of the midface and each of three subsets of 6 subjects will have a primary deficit/deformity of the nose, lips, and chin. 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Nikolis, Erevna Innovations Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819502
- Sponsor's protocol ID
- 02-2023-HIT-PRF
- Acronym
- HIT-PRF
- Status last verified
- Feb 2025
- First submitted
- 6 Apr 2023
- Last updated
- 4 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Trial Evaluating the "Profile HIT" (Holistic Individualized Treatment)
- ClinicalTrials.gov ID
- NCT05819502
- Acronym / sponsor ID
- HIT-PRF / 02-2023-HIT-PRF
- Conditions
- Aesthetic
- Keywords
- Hyaluronic acid, Fillers, Volumization, Facial Profile, Patient Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 24 Feb 2024 (actual)
- Study completion
- 24 Mar 2024 (actual)
- First posted
- 19 Apr 2023 (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 "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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will consist of an open-label, prospective, cohort trial design. Eighteen subjects will be recruited. Subjects will be recruited based on their primary deficit, where all subjects must have a mild or greater deficit of the midface and each of three subsets of 6 subjects will have a primary deficit/deformity of the nose, lips, and chin. 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Restylane line of injectables |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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:
- 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
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 injectablesRestylane fillers are manufactured by Q-Med AB, part of the Galderma Group. | Drug | Treatment |
Primary outcome
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.
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 4 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane line of injectables 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 5 inclusion and 18 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 4 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.
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?
Primary Endpoint - Global Aesthetics Improvement Scale (GAIS) (time frame: At week 8). 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 4 Feb 2025.