Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%

Nasolabial Folds Correction Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273556
• Other study ID #: E0817
• Status: Completed
• Phase: N/A
• First received: September 1, 2017
• Last updated: September 1, 2017
• Start date: April 28, 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: September 2017
• Source: Derming SRL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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;

• 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

Exclusion Criteria:

• 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);

• 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.

Related Conditions & MeSH terms

• Nasolabial Folds Correction

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Italy	DermIng S.r.l. Single Member Company	Monza	MB

Sponsors (1)

Lead Sponsor	Collaborator
Derming SRL

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline visit (T0), Week 4 (T4)
Secondary	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.	Baseline visit (T0), Week 4 (T4)
Secondary	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.	Immediately after the injection procedure (T0A), 2 hours after the injection procedure (T2h)
Secondary	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)	Baseline visit (T0), Week 4 (T4)