Efficacy and Tolerance Evaluation of a Bio-revitalizing Product Containing Hyaluronic Acid With High and Low Molecular Weight
NCT03270293 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2017-09-05
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
Interventions
- DEVICE
-
Profhilo
Sponsors & Collaborators
-
Derming SRL
lead OTHER
Principal Investigators
-
Adele Sparavigna, Doctor · Derming SRL
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-03-31
- Primary Completion
- 2015-07-31
- Completion
- 2015-08-31
Countries
- Italy
Study Locations
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