| Registry | NCT03270293 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 64 (Actual) |
| Sponsor | Derming SRL (Other) |
| Conditions | Malar and Sub-malar Volume Deficiency |
| Interventions | Profhilo (Device) |
| Dates | start 2015-03-01, primary completion 2015-07-01, completion 2015-08-01, first posted 2017-09-01, last updated 2017-09-05 |
| Locations | 1 site in Italy |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Profhilo | Experimental | Device: 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. |
Sex: Female, ages: 30 Years to 60 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| DERMING | Monza, Monza-brianza | Italy |