Clinical trial NCT03273556: Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Folds Correction
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 27
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wrinkle Severity Rating Scale (WSRS) grade variation from baseline
timeFrame: Baseline visit (T0), Week 4 (T4)
Secondary outcomes:
measure: The Global Aesthetic Improvement Scale (GAIS) grade variation from baseline
timeFrame: Baseline visit (T0), Week 4 (T4)
measure: Self grading
timeFrame: Immediately after the injection procedure (T0A), 2 hours after the injection procedure (T2h)
measure: Determination of profilometric parameters
timeFrame: Baseline visit (T0), Week 4 (T4)
Other outcomes:
Locations:
city: Monza
country: Italy
facility: DermIng S.r.l. Single Member Company
state: MB
Study officials:
References: