Face Skin LaxityNCT04239768
Efficacy of an Antiage Aesthetic Treatment for the Middle and Inferior Third of the Face
A study testing MonoDermà HA gel combined to a low level laser in people with Face Skin Laxity, run by Derming SRL at 1 site in Italy.
Trial summary
Primary endpoint of the study is to evaluate clinically and by non-invasive instrumental evaluations the aesthetic performance, on the third middle and inferior of the face, of "MonoDermà HA Bio-revitalizing gel", an intradermal filler containing hyaluronic acid, combined to a low level laser therapy (LLLT) to obtain… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Face Skin Laxity
- What is being tested?
- MonoDermà HA gel combined to a low level laser
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2019to 17 Jan 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female sex;
- Caucasian race;
- non smokers;
- no alcohol abuse and/or drug use;
- 40-65 years;
- FVLS 2-4 ;
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- available and able to return to the study site for the post-procedural follow-up examinations;
- accepting not to change their habits regarding food, physical activity, cosmetic and cleansing products for the face;
- accepting not to expose their face to strong UV irradiation (UV session and/or sun bathes) during the entire duration of the study, without appropriate sun protection;
- accepting to sign the informed consent form.
Who cannot join
- Pregnancy (only for female subjects not in menopause);
- lactation (only for female subjects not in menopause);
- smokers;
- alcohol abuse and/or drug use;
- female subjects not in menopause, who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
- female subjects not in menopause, who do not accept to perform the pregnancy test at T0 and T1 (before the 1st and the 2nd aesthetic procedure);
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- Body Mass Index (BMI) variation (± 1) during the study period;
- having performed face treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 6 months beginning of the study;
- having used permanent filler in the past;
- change in the normal habits regarding food, physical activity, face cosmetic, cleansing and make-up use during the month preceding the test;
- sensitivity to the test filler or its ingredients, including delayed hypersensitivity to hyaluronic acid and granulomatous reactions (to be assessed by the investigator during the baseline);
- subjects whose insufficient adhesion to the study protocol is foreseeable;
- participation in a similar study currently or during the previous 9 months;
- dermatitis;
- presence of cutaneous disease on the tested area, as lesions, scars, malformations;
- subjects that tend to develop hypertrophic scars;
- recurrent facial/labial herpes;
- clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne);
- diabetes;
- endocrine disease;
- hepatic disorder;
- renal disorder;
- cardiac disorder;
- pulmonary disease;
- cancer;
- neurological or psychological disease;
- inflammatory/immunosuppressive disease;
- drug allergy;
- anticoagulants and antiplatelet drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment started more than 1 year ago);
- using of drugs able to influence the test results in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerance Evaluation of an Antiage Aesthetic Treatment for the Middle and Inferior Third of the Face
Primary endpoint of the study is to evaluate clinically and by non-invasive instrumental evaluations the aesthetic performance, on the third middle and inferior of the face, of "MonoDermà HA Bio-revitalizing gel", an intradermal filler containing hyaluronic acid, combined to a low level laser therapy (LLLT) to obtain a stable photo-cross-linking effect inside the dermis.
- Conditions
- Face Skin Laxity
- Being tested
- MonoDermà HA gel combined to a low level laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonoDermà HA gel combined to a low level laserDevice
Two intradermal injections of the filler were performed during the basal and after 1 month, on the middle and inferior third of the face (1ml for each face side) using a needle (30G).
Immediately after both injection procedures, LLLT session were performed on the same face area for a total of 8 minutes, using three different wavelengths (450 nm, 650 nm and 1064 nm) simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| MonoDermà HA gel combined to a low level laser | Experimental | "Monodermà HA Bio-revitalizing gel" is a sterile, biodegradable, isotonic intradermal filler produced by Innate S.r.l. (Italy) and distributed by Giuliani S.p.A. (Italy) in non-pyrogenic pre-filled syringe of 2 ml containing 2% (20mg/ml) of medium chain (1.0-1.5 x 106 Dalton) hyaluronic acid (HA), obtained from bacterial fermentation, in a physiologic buffer (see Appendix 1) and used as a filler for the correction of deep skin sagging and roughness. Receives: Device: MonoDermà HA gel combined to a low level laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkle Severity Rating Scale (WSRS) grade variation
Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where:
Grade 1 (absent): no visible nasolabial fold; continuous skin line. Grade 2 (mild): shallow but visible nasolabial fold with a slight indentation; minor facial feature.
Grade 3 (moderate): moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched.
Grade 4 (severe): very long and deep nasolabial folds; prominent facial feature; <2mm visible fold when stretched.
Grade 5 (very severe): extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched.
Measured: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Facial Volume Loss Scale (FVLS) grade variation
Reduction of face volume loss corresponding to a decrease from the baseline of the Facial Volume Loss Scale (FVLS) where:
Grade 1: Mild flattening or shadowing of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). No prominent bony landmarks. No visibility of underlying musculature.
Grade 2: An intermediate point between grade 1 and grade 3. Grade 3: Moderate concavity of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas. Prominence of bony landmarks. May have visibility of underlying musculature.
Grade 4: An intermediate point between grade 3 and grade 5. Grade 5: Severe indentation of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). Severe prominence of bony landmarks. Clear visibility of underlying musculature.
Measured: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Photographic documentation (3D pictures)
Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.
Measured: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Face volume variation
Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software
Measured: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start14 Oct 2019
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Face Skin LaxityStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derming SRL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adele Sparavigna, Derming SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239768
- Sponsor's protocol ID
- E0919
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance Evaluation of an Antiage Aesthetic Treatment for the Middle and Inferior Third of the Face
- ClinicalTrials.gov ID
- NCT04239768
- Acronym / sponsor ID
- E0919
- Conditions
- Face Skin Laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 27 Jan 2020 (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.
Primary endpoint of the study is to evaluate clinically and by non-invasive instrumental evaluations the aesthetic performance, on the third middle and inferior of the face, of "MonoDermà HA Bio-revitalizing gel", an intradermal filler containing hyaluronic acid, combined to a low level laser therapy (LLLT) to obtain a stable photo-cross-linking effect inside the dermis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MonoDermà HA gel combined to a low level laser | Experimental | Device: MonoDermà HA gel combined to a low level laser"Monodermà HA Bio-revitalizing gel" is a sterile, biodegradable, isotonic intradermal filler produced by Innate S.r.l. (Italy) and distributed by Giuliani S.p.A. (Italy) in non-pyrogenic pre-filled syringe of 2 ml containing 2% (20mg/ml) of medium chain (1.0-1.5 x 106 Dalton) hyaluronic acid (HA), obtained from bacterial fermentation, in a physiologic buffer (see Appendix 1) and used as a filler for the correction of deep skin sagging and roughness. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- female sex;
- Caucasian race;
- non smokers;
- no alcohol abuse and/or drug use;
- 40-65 years;
Key exclusion criteria (30 listed)
- Pregnancy (only for female subjects not in menopause);
- lactation (only for female subjects not in menopause);
- smokers;
- alcohol abuse and/or drug use;
- female subjects not in menopause, who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
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 |
|---|---|---|
| MonoDermà HA gel combined to a low level laserTwo intradermal injections of the filler were performed during the basal and after 1 month, on the middle and inferior third of the face (1ml for each face side) using a needle (30G). Immediately after both injection procedures, LLLT session were performed on the same face area for a total of 8 minutes, using three different wavelengths (450 nm, 650 nm and 1064 nm) simultaneously. | Device | MonoDermà HA gel combined to a low level laser |
Primary outcome
Wrinkle Severity Rating Scale (WSRS) grade variation
Time frame: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where: Grade 1 (absent): no visible nasolabial fold; continuous skin line. Grade 2 (mild): shallow but visible nasolabial fold with a slight indentation; minor facial feature. Grade 3 (moderate): moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched. Grade 4 (severe): very long and deep nasolabial folds; prominent facial feature; <2mm visible fold when stretched. Grade 5 (very severe): extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched.
Facial Volume Loss Scale (FVLS) grade variation
Time frame: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Reduction of face volume loss corresponding to a decrease from the baseline of the Facial Volume Loss Scale (FVLS) where: Grade 1: Mild flattening or shadowing of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). No prominent bony landmarks. No visibility of underlying musculature. Grade 2: An intermediate point between grade 1 and grade 3. Grade 3: Moderate concavity of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas. Prominence of bony landmarks. May have visibility of underlying musculature. Grade 4: An intermediate point between grade 3 and grade 5. Grade 5: Severe indentation of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). Severe prominence of bony landmarks. Clear visibility of underlying musculature.
Photographic documentation (3D pictures)
Time frame: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.
Face volume variation
Time frame: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software
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 30 Jan 2020.
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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 MonoDermà HA gel combined to a low level laser in people with Face Skin Laxity, run by Derming SRL at 1 site in Italy.
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 10 inclusion and 30 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 30 Jan 2020. 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 Italy. 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?
Wrinkle Severity Rating Scale (WSRS) grade variation (time frame: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)). The study lists 4 primary outcomes in all. 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 30 Jan 2020.