Efficacy and Tolerance Evaluation of an Injective Treatment for the Area Around the Eyes

NCT03881189 | Completed

• 1 other identifier: E1518
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and tolerance evaluation of an intradermal injective HA and aminoacids based treatment for the area around the eyes

Conditions

Under-eyes Dark Circles

Outcome Measures

Primary Outcomes (5)

• Change from baseline of wrinkles grade around the eyes

  Visual score of crow's feet, according to a reference photographic scale from 0 (no wrinkles) to 7 (very marked wrinkles)

  T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)

• Change from baseline of dark circles grade

  Visual score of dark circles grade, according to a reference photographic scale from 0 (absent) to 4 (very marked)

  T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)

• Change from baseline of roughness profilometric parameters

  Crow's feet profilometric parameters measured by Primos compact portable device (GFMesstechnik). Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth.

  T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)

• Change from baseline of dark circles colorimetric parameters

  Dark circles colorimetric measured by Chroma Meter CR-200® . L\* represent the lightness of the colour, a\* represent the red component of the colour, b\* represent the dark component of the colour

  T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)

• Change from baseline of spectrophotometrical value

  Dark circles spectrophotometrical color value measured by a visible-UV-IR spectrophotometer

  T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)

Secondary Outcomes (1)

• change from of photographic documentation

  T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)

Study Arms (1)

SUNEKOS ® 200

EXPERIMENTAL

The 1st intradermal treatment (T1i) with "Sunekos ® 200" was carried out during the basal visit (T0), after basal evaluations planned by the study procedure, and then repeated 2 more times with an interval of 15 days (T2i and T3i)

Device: SUNEKOS® 200

Interventions

SUNEKOS® 200 DEVICE

The intradermal injection procedure was performed bilaterally, on the area around the eyes including the eyelids, using periosteal and subepidermal injection techniques. This injective procedure consists of micro-wheals of 0.2 ml just above the periosteum and micro-wheals of 0.1 ml very superficially, just under epidermis.

SUNEKOS ® 200

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female sex,
• years,
• dark circles,
• available and able to return to the study site for the post-procedural follow-up examinations;
• 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, without appropriate sun protection;
• accepting to sign the informed consent form

You may not qualify if:

• Pregnancy;
• lactation;
• smokers;
• alcohol or drug abusers;
• 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 at T0 (before the 1st aesthetic procedure) and at T3i (1 month after the 1st injection treatment execution, before the 3rd aesthetic 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 6 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 currently or during the previous 9 months.
• Dermatitis;
• presence of cutaneous disease on the tested area, as lesions, scars, malformations;

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DERMING

Milan, MI, 20159, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 19, 2019
• Study Start: November 28, 2018
• Primary Completion: March 12, 2019
• Study Completion: March 12, 2019
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

IT (1)