Status:
COMPLETED
Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%
Lead Sponsor:
Derming SRL
Conditions:
Nasolabial Folds Correction
Eligibility:
FEMALE
40-65 years
Phase:
NA
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 Lid...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2017
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03273556
Start Date
April 28 2017
End Date
May 31 2017
Last Update
September 6 2017
Active Locations (1)
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1
DermIng S.r.l. Single Member Company
Monza, MB, Italy, 20900