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

NCT04239768 | Completed

• 1 other identifier: E0919
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Face Skin Laxity

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

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

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.

MonoDermà HA gel combined to a low level laser

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female sex;
• Caucasian race;
• non smokers;
• no alcohol abuse and/or drug use;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DERMING

Milan, MI, 20159, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: October 14, 2019
• Primary Completion: January 17, 2020
• Study Completion: January 17, 2020
• Last Updated: January 30, 2020

Record last verified: 2020-01

Locations

IT (1)