Face Skin Laxity
Conditions
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.
Interventions
DEVICEMonoDermà HA gel combined to a low level laser
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.
Sponsors
Derming SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wrinkle Severity Rating Scale (WSRS) grade variation | Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 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. |
| Facial Volume Loss Scale (FVLS) grade variation | Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 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. |
| Photographic documentation (3D pictures) | Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3) | Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system. |
| Face volume variation | Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3) | Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software |
Countries
Italy
Outcome results
None listed