Efficacy of an Antiage Aesthetic Treatment for the Middle... | NCT04239768

NCT04239768

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MonoDermà HA gel combined to a low level laser	Experimental	"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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MonoDermà HA gel combined to a low level laser	Device	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.

Outcomes Module

Primary Outcomes

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

Eligibility Module

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.