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

NCT ID: NCT03270293

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-08-31

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.

Conditions

Malar and Sub-malar Volume Deficiency

Study Design

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

Study Groups

Profhilo

The intradermal procedure was performed bilaterally on the face, at level of the following five points:

1. zygomatic protuberance

2. nostril's angle

3. inferior margin of tragus

4. lip marionette lines

5. mandibular angle. The amount of product injected, was 0.2 ml for each injection-point.

Group Type: EXPERIMENTAL

Profhilo

Intervention Type: DEVICE

Interventions

Profhilo

Intervention Type: DEVICE

Other Intervention Names

IBSA

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Derming SRL

OTHER

Sponsor Role: lead

Responsible Party

Adele Sparavigna

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adele Sparavigna, Doctor

Role: PRINCIPAL_INVESTIGATOR

Derming SRL

Locations

DERMING

Monza, Monza-brianza, Italy

Countries

Italy

Other Identifiers

E1214

Identifier Type: -

Identifier Source: org_study_id