Nasolabial Folds CorrectionNCT03273556
Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%
A study testing Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3% and Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) in people with Nasolabial Folds Correction, run by Derming SRL at 1 site in Italy.
Trial summary
Evaluation of the filler performance on the nasolabial folds of Aliaxin® EV with and without lidocaine 0.3%: comparison within subjects (half face method) 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
- Nasolabial Folds Correction
- What is being tested?
- Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3% and Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- 28 Apr 2017to 31 May 2017
- 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;
- age 40-65 years;
- WSRS 2-4
- asking for nasolabial folds correction;
- execution of any medical/aesthetic procedure, including dental surgery, in the past that foresaw the use of lidocaine as local anesthetic
- available and able to return to the study site for the post-procedural follow-up examinations;
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- agreeing to present at each study visit without make-up;
- accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products;
- accepting not to expose their face to strong UV irradiation (UV session, 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;
- lactation;
- smokers;
- alcohol or drug abusers;
- subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
- subjects not in menopause who do not accept to perform the pregnancy test at T0 (before the aesthetic procedure);
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- Body Mass Index (BMI) variation (± 1) during the study period;
- performing skin treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 6 months prior to the study start;
- performing 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 product or its ingredients (to be assessed by the investigator during the baseline visit);
- subjects whose insufficient adhesion to the study protocol is foreseeable;
- participation in a similar study currently or during the previous 3 months.
- dermatitis;
- presence of cutaneous disease on the tested area, as lesions, scars, malformations;
- 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 starting more than 1 year ago),
- using of drugs able to influence the test results in the investigator opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%: Comparison Within Subjects (Half Face Method)
Evaluation of the filler performance on the nasolabial folds of Aliaxin® EV with and without lidocaine 0.3%: comparison within subjects (half face method)
Read the detailed description
Comparative, randomized, mono-centre spontaneous trial, under dermatological control, that foresaw the comparison within subjects of the investigational product versus investigational product with Lidocaine 0.3% (half face method); assignation of right or left face side to the two injective treatments was choose by the Investigator according to a previously defined randomisation list.
Primary end point of the study was to evaluate the filling and bio-revitalizing activity on nasolabial folds of the product Aliaxin® EV Essential Volume, in women aged 40-65 years.
It was also aim of this study to show if the addition of Lidocaine 0.3% to the investigational product (extemporaneous mixture) could have reduced the discomfort/pain sensation perceived by the subject during the injection procedure, without altering the aesthetic performance.
- Conditions
- Nasolabial Folds Correction
- Being tested
- Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%, Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%Device
The injective treatment was performed, during T0 visit after the basal evaluations, mono-laterally on nasolabial fold,(right or left face side in according to a previously defined randomisation list).
A quantity of Aliaxin® Ev (up to a maximum of 0.5 ml) with Lidocaine 0.3% was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.
Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.)Device
The injective treatment was performed on the contralateral nasolabial fold during T0 visit, after the basal evaluations .
A quantity of Aliaxin® Ev up to a maximum of 0.5 ml was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.
| Study group | Role | What they receive |
|---|---|---|
| Aliaxin® EV Essential Volume | Experimental | Comparison within subjects of Aliaxin® EV Essential Volume with and without Lidocaine 0.3% Receives: Device: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%; Device: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkle Severity Rating Scale (WSRS) grade variation from baseline
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 visit (T0), Week 4 (T4)
Secondary outcomes (3)
The Global Aesthetic Improvement Scale (GAIS) grade variation from baseline
Aesthetic improvement in the subjects' midface from their pretreatment state according to a five point scale:
- Very much improved: Optimal cosmetic result for the implant in this patient.
- Much improved: Marked improvement in appearance from initial condition, but not completely optimal for this patient. A touch up will slightly improve the result.
- Improved: Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated.
- No change: The appearance is essentially the same as the original condition.
- Worse:The appearance in worst than the original condition.
Measured: Baseline visit (T0), Week 4 (T4)
Self grading
Immediately and 2 hours after the aesthetic procedure, each volunteers scored its own sensations thanks to a visual analogic scale (VAS 10 units length) as follow:
- Stinging (0= no stinging to 10= strong stinging)
- Itching (0= no itching to 10= strong itching)
- Tightening (0= no tightening to 10= strong tightening)
- Burning (0= no burning to 10= strong burning)
- Pain (0= no pain to 10= strong pain)
- Discomfort (0= no discomfort to 10= strong discomfort) In order to highlight any differences between the side treated with the investigational product and the one treated with the study product + lidocaine 0.3%, the VAS score will be expressed separately for each of the two treated sides.
Measured: Immediately after the injection procedure (T0A), 2 hours after the injection procedure (T2h)
Determination of profilometric parameters
Variation from baseline of the nasolabial fold profilometric parameters versus baseline. Profilometric parameters are expressed in in micron.
A picture of nasolabial fold area is taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters:Ra (average roughness) Rt (wrinkles total high), Rv (wrinkles maximum depth)
Measured: Baseline visit (T0), Week 4 (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start28 Apr 2017
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Folds CorrectionStudies 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
- 27 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
- NCT03273556
- Sponsor's protocol ID
- E0817
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2017
- Last updated
- 6 Sep 2017
- 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 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%: Comparison Within Subjects (Half Face Method)
- ClinicalTrials.gov ID
- NCT03273556
- Acronym / sponsor ID
- E0817
- Conditions
- Nasolabial Folds Correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 6 Sep 2017 (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.
Evaluation of the filler performance on the nasolabial folds of Aliaxin® EV with and without lidocaine 0.3%: comparison within subjects (half face method)
Detailed description
Comparative, randomized, mono-centre spontaneous trial, under dermatological control, that foresaw the comparison within subjects of the investigational product versus investigational product with Lidocaine 0.3% (half face method); assignation of right or left face side to the two injective treatments was choose by the Investigator according to a previously defined randomisation list.
Primary end point of the study was to evaluate the filling and bio-revitalizing activity on nasolabial folds of the product Aliaxin® EV Essential Volume, in women aged 40-65 years.
It was also aim of this study to show if the addition of Lidocaine 0.3% to the investigational product (extemporaneous mixture) could have reduced the discomfort/pain sensation perceived by the subject during the injection procedure, without altering the aesthetic performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aliaxin® EV Essential Volume | Experimental | Device: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%, Device: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.)Comparison within subjects of Aliaxin® EV Essential Volume with and without Lidocaine 0.3% |
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;
- age 40-65 years;
- WSRS 2-4
- asking for nasolabial folds correction;
- execution of any medical/aesthetic procedure, including dental surgery, in the past that foresaw the use of lidocaine as local anesthetic
Key exclusion criteria (29 listed)
- Pregnancy;
- lactation;
- smokers;
- alcohol or drug abusers;
- 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 |
|---|---|---|
| Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%The injective treatment was performed, during T0 visit after the basal evaluations, mono-laterally on nasolabial fold,(right or left face side in according to a previously defined randomisation list). A quantity of Aliaxin® Ev (up to a maximum of 0.5 ml) with Lidocaine 0.3% was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect. | Device | Aliaxin® EV Essential Volume |
| Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.)The injective treatment was performed on the contralateral nasolabial fold during T0 visit, after the basal evaluations . A quantity of Aliaxin® Ev up to a maximum of 0.5 ml was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect. | Device | Aliaxin® EV Essential Volume |
Primary outcome
Wrinkle Severity Rating Scale (WSRS) grade variation from baseline
Time frame: Baseline visit (T0), Week 4 (T4)
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.
3 secondary outcomes
The Global Aesthetic Improvement Scale (GAIS) grade variation from baseline
Time frame: Baseline visit (T0), Week 4 (T4)
Self grading
Time frame: Immediately after the injection procedure (T0A), 2 hours after the injection procedure (T2h)
Determination of profilometric parameters
Time frame: Baseline visit (T0), Week 4 (T4)
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 6 Sep 2017.
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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 Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3% and Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) in people with Nasolabial Folds Correction, 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 29 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 6 Sep 2017. 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 from baseline (time frame: Baseline visit (T0), Week 4 (T4)). 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 6 Sep 2017.