Skin QualityNCT04172740
RADIESSE Injection in Perioral and Marionette Lines
A study testing Radiesse (calcium hydroxylpatite) in people with Skin Quality, run by Erevna Innovations Inc. at 1 site in Canada.
Trial summary
Following treatment with Radiesse, many patients mention an improvement in skin texture This observation is independent from the improvement observed on their facial shape. There is therefore a need to identify and quantify changes in skin parameters following treatment with Radiesse Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Quality
- What is being tested?
- Radiesse (calcium hydroxylpatite)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 13 Nov 2019to 11 Jul 2020
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At the time of consent, women between the ages of 18 and 80 years old;
- Patient requires lower face treatment (perioral/marionette region) with RADIESSE;
- Willingness to comply with study requirements;
- Provide written consent;
- Patient has a rating of 2 or 3 at Baseline on the Merz Marionette Grading Scale, as per the investigator;
- Accepted the obligation not to receive any other facial procedures through the follow-up;
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- Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits;
- No previous facial fillers for a period of 12 months prior to this study;
- No previous facial fillers in the lower face for 18 months prior to this study.
Who cannot join
- Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
- Hypersensitivity to RADIESSE, calcium hydroxylpatite filler or local anesthetics;
- Patient has received any lower face treatment during the last 12 months, or neuromodulator in the last 6 months;
- Patient has received mentalis muscle injections of any kind (BoNT-A or fillers) in the last 6 months;
- Patients meeting any official RADIESSE contra-indications;
- Patients presenting with porphyria;
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- Inability to comply with follow-up and abstain from facial injections during the study period;
- Heavy smokers, classified as smoking more than 12 cigarettes per day;
- History of severe or multiple allergies manifested by anaphylaxis;
- Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
- Previous surgery including aesthetic facial surgical therapy or liposuction, piercing, or tattoos in the treatment area;
- History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head and neck region;
- Facial psoriasis, eczema, acne, rosacea, perioral dermatitis and herpes zoster in the treatment area;
- Cancer or precancer in the treatment area, e.g. actinic keratosis;
- History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment;
- Patients using immunosuppressants;
- Patients with a tendency to form hypertrophic scars or any other healing disorders;
- Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anaesthetics (e.g., certain anti-arrhythmics);
- Patients administered dental block or topical administration of lidocaine;
- Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Skin Quality Parameters Following RADIESSE Injection in Perioral and Marionette Lines
Following treatment with Radiesse, many patients mention an improvement in skin texture This observation is independent from the improvement observed on their facial shape. There is therefore a need to identify and quantify changes in skin parameters following treatment with Radiesse
- Conditions
- Skin Quality
- Being tested
- Radiesse (calcium hydroxylpatite)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiesse (calcium hydroxylpatite)Device
RADIESSE® injectable implant is a sterile, non-pyrogenic, semi-solid, cohesive implant, whose principle component is synthetic calcium hydroxylapatite (CaHA) suspended in a gel carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. RADIESSE injectable implant has a CaHA particle size range of 25-45 microns. RADIESSE is available in 1.5cc and 0.8cc pre-filled syringes.
RADIESSE injectable implant is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Radiesse (calcium hydroxylpatite) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydration
Assessment of changes in hydration at Month 3, as assessed with the Courage and Khazaka system device, following the injection of RADIESSE, in perioral and marionette lines regions
Measured: Month 3
Secondary outcomes (7)
Hydration
Changes in hydration at Month 6, as assessed with the Courage and Khazaka system device;
Measured: Month 6
Elasticity
Changes in elasticity at Month 3 and 6, as assessed with the Courage and Khazaka system device;
Measured: Month 3 and 6
pH
Changes in pH and quality of skin barrier function (TEWL - Trans Epidermal Water Loss) at Months 3 and 6, as assessed with the Courage and Khazaka sys
Measured: Month 3 and 6
Skin texture
Changes in skin surface textural irregularities, smoothness, roughness, wrinkles and scaliness) at Months 3 and 6, as assessed with the Courage and Khazaka system.
Measured: Month 3 and 6
Merz validated marionette scale
Changes in the aesthetic improvement using the Merz validated marionette scale at Months 3 and 6. This is a 5-point scale, where 0 = no lines and 4 = very severe lines.
Measured: Month 3 and 6
Global Assessment Improvement Scale
Changes in the aesthetic appearance using the Global Assessment Improvement Scale (GAIS) using standardised 2D/3D photographs for patients and blinded physicians at Months 3 and 6;
Measured: Months 3 and 6
Fitzpatrick Wrinkle Assessment Scale
- Changes in skin quality using the modified Fitzpatrick Wrinkle Assessment Scale (FWAS) and standardised 2D/3D photographs at Months 3 and 6.
Measured: Months 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start13 Nov 2019
- Primary completion11 Jul 2020
- Study completion11 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin QualityStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Nikolis, FRCSC, Principal investigator, Erevna Innovations Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172740
- Sponsor's protocol ID
- 2019-VP-003R
- Status last verified
- Aug 2021
- First submitted
- 20 Nov 2019
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Skin Quality Parameters Following RADIESSE Injection in Perioral and Marionette Lines
- ClinicalTrials.gov ID
- NCT04172740
- Acronym / sponsor ID
- 2019-VP-003R
- Conditions
- Skin Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 11 Jul 2020 (actual)
- Study completion
- 11 Jul 2020 (actual)
- First posted
- 21 Nov 2019 (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.
Following treatment with Radiesse, many patients mention an improvement in skin texture This observation is independent from the improvement observed on their facial shape. There is therefore a need to identify and quantify changes in skin parameters following treatment with Radiesse
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Radiesse (calcium hydroxylpatite) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At the time of consent, women between the ages of 18 and 80 years old;
- Patient requires lower face treatment (perioral/marionette region) with RADIESSE;
- Willingness to comply with study requirements;
- Provide written consent;
- Patient has a rating of 2 or 3 at Baseline on the Merz Marionette Grading Scale, as per the investigator;
Key exclusion criteria (20 listed)
- Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
- Hypersensitivity to RADIESSE, calcium hydroxylpatite filler or local anesthetics;
- Patient has received any lower face treatment during the last 12 months, or neuromodulator in the last 6 months;
- Patient has received mentalis muscle injections of any kind (BoNT-A or fillers) in the last 6 months;
- Patients meeting any official RADIESSE contra-indications;
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 |
|---|---|---|
| Radiesse (calcium hydroxylpatite)RADIESSE® injectable implant is a sterile, non-pyrogenic, semi-solid, cohesive implant, whose principle component is synthetic calcium hydroxylapatite (CaHA) suspended in a gel carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. RADIESSE injectable implant has a CaHA particle size range of 25-45 microns. RADIESSE is available in 1.5cc and 0.8cc pre-filled syringes. RADIESSE injectable implant is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy). | Device | Treatment |
Primary outcome
Hydration
Time frame: Month 3
Assessment of changes in hydration at Month 3, as assessed with the Courage and Khazaka system device, following the injection of RADIESSE, in perioral and marionette lines regions
7 secondary outcomes
Hydration
Time frame: Month 6
Elasticity
Time frame: Month 3 and 6
pH
Time frame: Month 3 and 6
Skin texture
Time frame: Month 3 and 6
Merz validated marionette scale
Time frame: Month 3 and 6
Global Assessment Improvement Scale
Time frame: Months 3 and 6
Fitzpatrick Wrinkle Assessment Scale
Time frame: Months 3 and 6
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 23 Aug 2021.
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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, FRCSC 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 study testing Radiesse (calcium hydroxylpatite) in people with Skin Quality, 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 9 inclusion and 20 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 23 Aug 2021. 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?
Hydration (time frame: Month 3). 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 23 Aug 2021.