Efficacy and Tolerance Evaluation of a Bio-revitalizing Product Containing Hyaluronic Acid With High and Low Molecular Weight

Derming SRL64 enrolled

Overview

Primary end point of the study was to evaluate clinically and by non-invasive instrumental evaluations tolerance and efficacy of a bio-revitalizing product containing hyaluronic acid with high (H-HA) and low (L-HA) molecular weight; the micro-injection of the study product was performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of healthy female volunteers aged 30-60 years. It was also aim of this study to evaluate efficacy by the volunteers and tolerance both by investigator and volunteers.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malar and Sub-malar Volume Deficiency

Interventions

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * female sex * age 30-60 years * agreeing to present at each study visit without make-up * accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products * accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study, without appropriate sun protection * accepting to sign the Informed consent form. Exclusion Criteria: * pregnancy * lactation * subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study * subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, 4 and 8 weeks after the first biomineralising treatment execution * performing skin treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 12 months prior to the study start * performing 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 product or its ingredients (an accurate anamnestic assessment will performed by the investigator) * subjects whose insufficient adhesion to the study protocol is foreseeable * participation in a similar study actually or during the previous 3 months. * presence of cutaneous disease on the tested area, as lesions, scars, malformations * recurrent facial/labial herpes * clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.). * diabetes * endocrine disease * hepatic disorder * renal disorder * cardiac disorder * pulmonary disease * cancer * neurological or psychological disease * inflammatory/immunosuppressive disease * drug allergy. * anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago) * assumption of drugs able to influence the test results in the investigator opinion.

Outcomes

Primary Outcomes

Wrinkle Severity Rating Scale (WSRS) improvement

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.