Clinical trial NCT03274232: Face Photoaging: Efficacy and Tolerance Evaluation of an Intradermal Injective Treatment
Official title: Efficacy and Tolerance of an Injectable Medical Device Containing Hyaluronic Acid and Amino Acids: a Monocentric Six-month Open-label Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Face Skin Photoaging
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 25
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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; the micro-injections of the study product were performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of female volunteers aged 45-65 years, with photoaging of mild/moderate grade.

Eligibility criteria: Inclusion Criteria:

* - 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 Criteria:

* 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.

Primary outcomes:
measure: Variation of Wrinkle Severity Rating Scale (WSRS) grade
timeFrame: Basal visit (T0), 10 days(T2i), 20 days (T3i), 30 days (T4i), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
measure: Variation of Facial Volume Loss Scale (FVLS) grade
timeFrame: Basal visit (T0), 10 days(T2i), 20 days (T3i), 30 days (T4i), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
Secondary outcomes:
measure: Superficial skin hydration variation
timeFrame: Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
measure: Deep skin hydration variation
timeFrame: Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
measure: Skin plastoelasticity variation
timeFrame: Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
measure: Variation of profilometric parameters
timeFrame: Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
measure: Photographic documentation (3D pictures )
timeFrame: Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
measure: Face volume variation
timeFrame: Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)
Other outcomes:
Locations:
Study officials:
References: