Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%
- Conditions
- Nasolabial Folds Correction
- Interventions
- 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.)
- Registration Number
- NCT03273556
- Lead Sponsor
- Derming SRL
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 27
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aliaxin® EV Essential Volume Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) Comparison within subjects of Aliaxin® EV Essential Volume with and without Lidocaine 0.3% Aliaxin® EV Essential Volume Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3% Comparison within subjects of Aliaxin® EV Essential Volume with and without Lidocaine 0.3%
- Primary Outcome Measures
Name Time Method Wrinkle Severity Rating Scale (WSRS) grade variation from baseline 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.
- Secondary Outcome Measures
Name Time Method Determination of profilometric parameters Baseline visit (T0), Week 4 (T4) 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)The Global Aesthetic Improvement Scale (GAIS) grade variation from baseline Baseline visit (T0), Week 4 (T4) Aesthetic improvement in the subjects' midface from their pretreatment state according to a five point scale:
1. Very much improved: Optimal cosmetic result for the implant in this patient.
2. Much improved: Marked improvement in appearance from initial condition, but not completely optimal for this patient. A touch up will slightly improve the result.
3. Improved: Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated.
4. No change: The appearance is essentially the same as the original condition.
5. Worse:The appearance in worst than the original condition.Self grading Immediately after the injection procedure (T0A), 2 hours after the injection procedure (T2h) 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:
1. Stinging (0= no stinging to 10= strong stinging)
2. Itching (0= no itching to 10= strong itching)
3. Tightening (0= no tightening to 10= strong tightening)
4. Burning (0= no burning to 10= strong burning)
5. Pain (0= no pain to 10= strong pain)
6. 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.
Trial Locations
- Locations (1)
DermIng S.r.l. Single Member Company
🇮🇹Monza, MB, Italy