Clinical trial NCT04239768: Efficacy of an Antiage Aesthetic Treatment for the Middle and Inferior Third of the Face
Official title: Efficacy and Tolerance Evaluation of an Antiage Aesthetic Treatment for the Middle and Inferior Third of the Face
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Face Skin Laxity
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 24
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: Primary endpoint of the study is to evaluate clinically and by non-invasive instrumental evaluations the aesthetic performance, on the third middle and inferior of the face, of "MonoDermà HA Bio-revitalizing gel", an intradermal filler containing hyaluronic acid, combined to a low level laser therapy (LLLT) to obtain a stable photo-cross-linking effect inside the dermis.


Eligibility criteria: Inclusion Criteria:

* female sex;
* Caucasian race;
* non smokers;
* no alcohol abuse and/or drug use;
* 40-65 years;
* FVLS 2-4 ;
* available and able to return to the study site for the post-procedural follow-up examinations;
* accepting not to change their habits regarding food, physical activity, cosmetic and cleansing products for the face;
* accepting not to expose their face to strong UV irradiation (UV session and/or sun bathes) during the entire duration of the study, without appropriate sun protection;
* accepting to sign the informed consent form.

Exclusion Criteria:

* Pregnancy (only for female subjects not in menopause);
* lactation (only for female subjects not in menopause);
* smokers;
* alcohol abuse and/or drug use;
* female subjects not in menopause, who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
* female subjects not in menopause, who do not accept to perform the pregnancy test at T0 and T1 (before the 1st and the 2nd aesthetic procedure);
* Body Mass Index (BMI) variation (± 1) during the study period;
* having performed face treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 6 months beginning of the study;
* having used 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 filler or its ingredients, including delayed hypersensitivity to hyaluronic acid and granulomatous reactions (to be assessed by the investigator during the baseline);
* subjects whose insufficient adhesion to the study protocol is foreseeable;
* participation in a similar study currently or during the previous 9 months;
* dermatitis;
* presence of cutaneous disease on the tested area, as lesions, scars, malformations;
* subjects that tend to develop hypertrophic scars;
* 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 started more than 1 year ago);
* using of drugs able to influence the test results in the investigator's opinion.

Primary outcomes:
measure: Wrinkle Severity Rating Scale (WSRS) grade variation
timeFrame: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
measure: Facial Volume Loss Scale (FVLS) grade variation
timeFrame: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
measure: Photographic documentation (3D pictures)
timeFrame: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
measure: Face volume variation
timeFrame: Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: DERMING
state: MI
Study officials:
References: