Clinical trial NCT03270293: Efficacy and Tolerance Evaluation of a Bio-revitalizing Product Containing Hyaluronic Acid With High and Low Molecular Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malar and Sub-malar Volume Deficiency
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 64
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Wrinkle Severity Rating Scale (WSRS) improvement
timeFrame: Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).
measure: Facial Volume Loss Scale (FVLS) improvement
timeFrame: 16 weeks
measure: Surface microrelief's regularity improvement
timeFrame: Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).
measure: Determination of profilometric parameters
timeFrame: Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).
measure: Skin plastoelasticity improvement
timeFrame: Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).
measure: Superficial skin hydration improvement
timeFrame: Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).
measure: Deep skin hydration improvement
timeFrame: Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).
Secondary outcomes:
Other outcomes:
Locations:
city: Monza
country: Italy
facility: DERMING
state: Monza-brianza
Study officials:
affiliation: Derming SRL
name: Adele Sparavigna, Doctor
role: PRINCIPAL_INVESTIGATOR
References: