Status:
COMPLETED
Efficacy and Tolerance Evaluation of a Bio-revitalizing Product Containing Hyaluronic Acid With High and Low Molecular Weight
Lead Sponsor:
Derming SRL
Conditions:
Malar and Sub-malar Volume Deficiency
Eligibility:
FEMALE
30-60 years
Phase:
NA
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) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03270293
Start Date
March 1 2015
End Date
August 1 2015
Last Update
September 5 2017
Active Locations (1)
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1
DERMING
Monza, Monza-brianza, Italy, 20900