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

NCT ID: NCT04239768

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2020-01-17

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MonoDermà HA gel combined to a low level laser

"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.

Group Type: EXPERIMENTAL

MonoDermà HA gel combined to a low level laser

Intervention Type: 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.

Interventions

MonoDermà 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Derming SRL

OTHER

Sponsor Role: lead

Responsible Party

Adele Sparavigna

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

DERMING

Milan, MI, Italy

Countries

Italy

Other Identifiers

E0919

Identifier Type: -

Identifier Source: org_study_id