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

Primary Purpose

Face Skin Laxity

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MonoDermà HA gel combined to a low level laser
Sponsored by
Derming SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Face Skin Laxity

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • DERMING

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MonoDermà HA gel combined to a low level laser

Arm Description

"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.

Outcomes

Primary Outcome Measures

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.
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.
Photographic documentation (3D pictures)
Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.
Face volume variation
Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software

Secondary Outcome Measures

Full Information

First Posted
January 21, 2020
Last Updated
January 28, 2020
Sponsor
Derming SRL
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1. Study Identification

Unique Protocol Identification Number
NCT04239768
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
January 17, 2020 (Actual)
Study Completion Date
January 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derming SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Face Skin Laxity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MonoDermà HA gel combined to a low level laser
Arm Type
Experimental
Arm Description
"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.
Intervention Type
Device
Intervention Name(s)
MonoDermà HA gel combined to a low level laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wrinkle Severity Rating Scale (WSRS) grade variation
Description
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.
Time Frame
Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Title
Facial Volume Loss Scale (FVLS) grade variation
Description
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.
Time Frame
Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Title
Photographic documentation (3D pictures)
Description
Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.
Time Frame
Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Title
Face volume variation
Description
Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software
Time Frame
Baseline (T0), 1 month (T1), 2 months (T2), 3 months (T3)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
DERMING
City
Milano
State/Province
MI
ZIP/Postal Code
20159
Country
Italy

12. IPD Sharing Statement

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

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