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

NCT03270293 | Completed

• 1 other identifier: E1214
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• 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.

  Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).

• Facial Volume Loss Scale (FVLS) improvement

  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.

  16 weeks

• Surface microrelief's regularity improvement

  Improvement of skin surface microrelief corresponding to a reduction of the clinical score of microrelief's regularity grade where Grade 1:very regular, Grade 2: regular, Grade 3: irregular, Grade 4: very irregular. Clinical evaluation of surface microrelief's regularity grade is carried out on the digital picture acquired by FotoFinderDermoscope with a magnification of 20X

  Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).

• Determination of profilometric parameters

  Reduction of the nasolabial fold and marionette lines profilometric parameters versus baseline where Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth. Replicas of nasolabial fold and marionette lines are obtained using silicone rubber. A picture of the skin replicas is taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to elaborate 3D representations of skin wrinkles as well as to measure skin principal profilometric parameters.

  Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).

• Skin plastoelasticity improvement

  Improvement of the principal torsiometric parameters Ue (immediate extensibility), Uf (final extensibility), Uv (viscoelasticity) and Ur (immediate elastic recovery).Skin firmness is measured with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK).

  Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).

• Superficial skin hydration improvement

  Improvement of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.

  Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).

• Deep skin hydration improvement

  Improvement of tissue dielectric constant value of superficial and deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland)

  Basal visit (T0), Week 4 (T4W) , Week 8 (T8W), Week 12 (T12W), Week 16 (T16W).

Study Arms (1)

Profhilo

EXPERIMENTAL

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.

Device: Profhilo

Interventions

Profhilo DEVICE

Also known as: IBSA

Profhilo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DERMING

Monza, Monza-brianza, 20900, Italy

Location

Study Officials

• Adele Sparavigna, Doctor

  Derming SRL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: September 1, 2017
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 5, 2017

Record last verified: 2016-01

Locations

IT (1)