Face Skin Photoaging
Conditions
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.
Interventions
DEVICESUNEKOS ® 200
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
Sponsors
Derming SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of Wrinkle Severity Rating Scale (WSRS) grade | Basal visit (T0), 10 days(T2i), 20 days (T3i), 30 days (T4i), 2 months (T2M) , 3 months (T3M), 6 months (T6M) | Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where: Grade 1 (absent): no visible nasolabial fold; continuous skin line. Grade 2 (mild): shallow but visible nasolabial fold with a slight indentation; minor facial feature. Grade 3 (moderate): moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched. Grade 4 (severe): very long and deep nasolabial folds; prominent facial feature; \<2mm visible fold when stretched. Grade 5 (very severe): extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched. |
| Variation of Facial Volume Loss Scale (FVLS) grade | Basal visit (T0), 10 days(T2i), 20 days (T3i), 30 days (T4i), 2 months (T2M) , 3 months (T3M), 6 months (T6M) | Reduction of face volume loss corresponding to a decrease from the baseline of the Facial Volume Loss Scale (FVLS) where Grade 1 Mild flattening or shadowing of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). No prominent bony landmarks. No visibility of underlying musculature. Grade 2 An intermediate point between grade 1 and grade 3. Grade 3 Moderate concavity of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas. Prominence of bony landmarks. May have visibility of underlying musculature. Grade 4 An intermediate point between grade 3 and grade 5. Grade 5 Severe indentation of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). Severe prominence of bony landmarks. Clear visibility of underlying musculature. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin plastoelasticity variation | Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M) | Improvement of the principal torsiometric parameters Ue (immediate extensibility), Uf (final extensibility), Uv (viscoelasticity) and Ur (immediate elastic recovery).Skin firmness is measured with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK). |
| Variation of profilometric parameters | Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M) | Reduction of the crow's feet lines profilometric parameters versus baseline where Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth. |
| Superficial skin hydration variation | Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M) | Improvement of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level. |
| Face volume variation | Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M) | Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software |
| Photographic documentation (3D pictures ) | Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M) | Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system. |
| Deep skin hydration variation | Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M) | Improvement of tissue dielectric constant value of superficial and deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland) |
Outcome results
None listed