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)

NCT03425955 | Completed

• 1 other identifier: E1817
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Face Photoaging

Outcome Measures

Primary Outcomes (3)

• Variation of wrinkles grade of the area around the eyes

  Reduction of grade of the area around the eyes corresponding to a decrease from the baseline of the Glogau's reference photographic scale clinical score where: Type 1 (No Wrinkles) Early photo-aging, mild pigment changes, minimal wrinkles, no 'age spots'; Type 2 (Wrinkles in Motion) Early to moderate photo-aging, appearance of lines only when face moves, early brown 'age spots', skin pores more prominent, early changes in skin texture; Type 3 (Wrinkles at Rest) Advanced photo-aging, prominent brown pigmentation, visible brown 'age spots', prominent and small blood vessels, wrinkles now present with face at rest; Type 4 (Only Wrinkles) Severe photoaging, wrinkles everywhere (at rest or moving) yellow-grey skin color, prior skin cancers, pre-cancerous skin changes (actinic keratosis).

  Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).

• Variation of Wrinkle Severity Rating Scale (WSRS) grade

  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.

  Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).

• Variation of Facial Volume Loss Scale (FVLS) grade

  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

  Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).

Secondary Outcomes (2)

• Photographic documentation (3D pictures)

  Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).

• Face volume variation

  Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).

Study Arms (2)

GROUP 1

EXPERIMENTAL

Normotypic or overweight subjects with rounded, oval or squared face (aged 35-50 years)

Device: SUNEKOS ® 200

GROUP 2

EXPERIMENTAL

Thin subjects with oval or triangular face and "sagging" skin (aged 45-60 years)

Device: "SUNEKOS® 1200" and "SUNEKOS® 200"

Interventions

SUNEKOS ® 200 DEVICE

4 micro-injection sessions of "SUNEKOS® 200" with an interval of 10 days. Two different injection techniques were carried out mono-laterally on the left or right face side randomly: "interstitial fluid technique" (IFT) on one face side; bolus technique on five pre-determined face points (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) on the contralateral face side.

GROUP 1

"SUNEKOS® 1200" and "SUNEKOS® 200" DEVICE

5 micro-injection sessions (one of the product "SUNEKOS® 1200" and four of "SUNEKOS® 200". "SUNEKOS® 1200" was injected bi-laterally on the face with cushion technique. 24 hours after the "SUNEKOS® 1200" treatment, 4 micro-injection sessions of "SUNEKOS® 200" with an interval of 10 days were performed . "SUNEKOS® 200" was injected with two different techniques, carried out mono-laterally on the left or right face side randomly: "retrograde interstitial fluid technique" (RIFT) on one face side; bolus technique on five pre-determined face points (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) on the contralateral face side.

GROUP 2

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DERMING

Milan, MI, 20149, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 8, 2018
• Study Start: October 19, 2017
• Primary Completion: December 21, 2017
• Study Completion: December 21, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Locations

IT (1)