Status:
COMPLETED
Face Photoaging: Efficacy and Tolerance Evaluation of an Intradermal Injective Treatment
Lead Sponsor:
Derming SRL
Conditions:
Face Skin Photoaging
Eligibility:
FEMALE
45-65 years
Phase:
NA
Brief Summary
Efficacy and tolerance evaluation of an intradermal injective treatment
Detailed Description
Primary end point of the study was to evaluate clinically and by non-invasive instrumental evaluations tolerance and efficacy of SUNEKOS ® 200 injectable treatment on main sign of face skin photoaging...
Eligibility Criteria
Inclusion
- \- female sex;
- age 45-65 years;
- mild/moderate cutaneous photoaging according to a reference photographic scale (see Appendix 8)
- skin phototype I, II and III according to Fitzpatrick's classification, with a preference to grade II-III (see par. 8.1)
- 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;
- accepting to sign the Informed consent form.
Exclusion
- Dependent on the volunteers' characteristics
- Pregnancy;
- lactation;
- subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
- Body Mass Index (BMI) variation (± 1) during the study period;
- subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, 30 days (T4i) and 2 months (T2M) after the first biomineralizing 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 (to be assessed by the investigator during the baseline visit);
- subjects whose insufficient adhesion to the study protocol is foreseeable;
- participation in a similar study actually or during the previous 6 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 :
October 27 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2017
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03274232
Start Date
October 27 2016
End Date
April 25 2017
Last Update
September 6 2017
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