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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03273556
• Date of registration: 01/09/2017
• Prospective Registration: No
• Primary sponsor: Derming SRL
• Public title: Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%
• Scientific 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)
• Date of first enrolment: April 28, 2017
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03273556
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Italy

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Nasolabial Folds Correction

Intervention(s)

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.)

Primary Outcome(s)

Wrinkle Severity Rating Scale (WSRS) grade variation from baseline [Time Frame: Baseline visit (T0), Week 4 (T4)]

Secondary Outcome(s)

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)]

The Global Aesthetic Improvement Scale (GAIS) grade variation from baseline [Time Frame: Baseline visit (T0), Week 4 (T4)]

Secondary ID(s)

E0817

Source(s) of Monetary Support

Please refer to primary and secondary sponsors