An interventional study of SUNEKOS® 200 in Under-eyes Dark Circles, sponsored by Derming SRL. Completed at 1 site in Italy. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-21.
Sponsored by Derming SRL · Not applicable, Interventional, and Treatment
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Efficacy and tolerance evaluation of an intradermal injective HA and aminoacids based treatment for the area around the eyes
Primary end point of this study was to evaluate clinically and by non-invasive instrumental measurements the aesthetic performance on the area around the eyes of the"SUNEKOS® 200" injective treatment. Precisely three micro-injection sessions with an interval of 15 days were performed by a specialized dermatologist using periosteal and subepidermal injection techniques, on the area around the eyes of female volunteers with dark circles.
An additional aim of this study is to evaluate the product tolerance by both the investigator and volunteers.
Derming SRL is the lead sponsor of 26 studies on the registry; none are open to participants now.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)
change from of photographic documentation
Photographic documentation of the area around the eyes
Time frame: T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)
Ran from Nov 2018 to primary completion in Mar 2019, 3 months.
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Derming SRL