Efficacy of an Antiage Aesthetic Treatment for the Middle and Inferior Third of the Face

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Tolerance Evaluation of an Antiage Aesthetic Treatment for the Middle and Inferior Third of the Face

Conditions
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Face Skin Laxity

Intervention / Treatment
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* Device: MonoDermà HA gel combined to a low level laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MonoDermà HA gel combined to a low level laser<br>Monodermà HA Bio-revitalizing gel is a sterile, biodegradable, isotonic intradermal filler produced by Innate S.r.l. (Italy) and distributed by Giuliani S.p.A. (Italy) in non-pyrogenic pre-filled syringe of 2 ml containing 2% (20mg/ml) of medium chain (1.0-1.5 x 106 Dalton) hyaluronic acid (HA), obtained from bacterial fermentation, in a physiologic buffer (see Appendix 1) and used as a filler for the correction of deep skin sagging and roughness. | Device: MonoDermà HA gel combined to a low level laser<br>* Two intradermal injections of the filler were performed during the basal and after 1 month, on the middle and inferior third of the face (1ml for each face side) using a needle (30G). Immediately after both injection procedures, LLLT session were performed on the same face area for a total of 8 minutes, using three different wavelengths (450 nm, 650 nm and 1064 nm) simultaneously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrinkle Severity Rating Scale (WSRS) grade variation | 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. | Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 
| Facial Volume Loss Scale (FVLS) grade variation | Reduction of face volume loss corresponding to a decrease from the baseline of the Facial Volume Loss Scale (FVLS) where: Grade 1: Mild flattening or shadowing of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). No prominent bony landmarks. No visibility of underlying musculature. Grade 2: An intermediate point between grade 1 and grade 3. Grade 3: Moderate concavity of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas. Prominence of bony landmarks. May have visibility of underlying musculature. Grade 4: An intermediate point between grade 3 and grade 5. Grade 5: Severe indentation of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). Severe prominence of bony landmarks. Clear visibility of underlying musculature. | Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 
| Photographic documentation (3D pictures) | Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system. | Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 
| Face volume variation | Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software | Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3) |