Clinical trial NCT03425955: Aesthetic Performance of an Intradermal Injection Treatment for Face Photoaging: Interstitial or Cushion Technique in Comparison to Bolus Technique at Five Points (Half - Face Method Within Subjects)
Official title: Aesthetic Performance of an Intradermal Injection Treatment for Face Photoaging: Interstitial or Cushion Technique in Comparison to Bolus Technique at Five Points (Half - Face Method Within Subjects)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Face Photoaging
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 12
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aesthetic performance of "SUNEKOS® 200" injectable treatment on main sign of face skin aging in normotypic or overweight subjects with rounded, oval or squared face and in thin subjects with oval or triangular face and "sagging" skin.Interstitial or cushion technique in comparison to bolus technique at five points (half - face method within subjects).

Detailed description: Spontaneous, open, clinical trial, conducted by one centre under dermatological control. Primary end point of the study was to evaluate clinically and by non-invasive instrumental measurements the aesthetic performance of "SUNEKOS® 200" injectable treatment on main sign of face skin aging in normotypic or overweight subjects with rounded, oval or squared face and in thin subjects with oval or triangular face and "sagging" skin.

The micro-injections of the study product were executed by a specialized dermatologist, on the face of female volunteers with photoaging of mild/moderate grade; to improve the treatment aesthetic performance two different injection techniques were carried out mono-laterally on the left or right face side randomly: "interstitial fluid technique" (IFT) for the 1st subjects' typology (aged 35-50 years) and "cushion technique" in association to "retrograde interstitial fluid technique" (RIFT) for the 2nd (aged 45-60). On the contralateral face side the injection treatment was performed by bolus technique on five pre-determined face points, preceding for the 2nd subjects' typology by cushion technique.

It was also aim of this study to evaluate tolerance both by investigator and volunteers and efficacy by the volunteers

Eligibility criteria: Inclusion Criteria:

* female sex,
* age 35-50 years for the group 1 and 45-60 years for the group 2,
* mild/moderate cutaneous photoaging according to a reference photographic scale
* skin phototype I, II and III according to Fitzpatrick's classification, with a preference to grade II-III ,
* 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:

* 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, 30 days (T4i) and 60 days (T60) after the first injection procedure,
* Body Mass Index (BMI) variation (± 1) during the study period,
* 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,
* 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);
* using of drugs able to influence the test results in the investigator opinion. The use of other drugs, not mentioned above, can be authorized by the Investigator.

Primary outcomes:
measure: Variation of wrinkles grade of the area around the eyes
timeFrame: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
measure: Variation of Wrinkle Severity Rating Scale (WSRS) grade
timeFrame: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
measure: Variation of Facial Volume Loss Scale (FVLS) grade
timeFrame: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
Secondary outcomes:
measure: Photographic documentation (3D pictures)
timeFrame: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
measure: Face volume variation
timeFrame: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
Other outcomes:
Locations:
city: Milano
country: Italy
facility: DERMING
state: MI
Study officials:
References: