An interventional study of SUNEKOS ® Body in Skin Flaccidity Inner Thighs Knees Arms, sponsored by Derming SRL. Completed at 1 site in Italy. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-04.
Sponsored by Derming SRL · Not applicable, Interventional, and Treatment
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The objective of this study is to investigate the efficacy of the "SUNEKOS® Body" in woman aged 40-65 years with skin flaccidity of the inner thighs, knees and arms.
Derming SRL is the lead sponsor of 26 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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 treatment was performed during T0 visit, after the basal evaluations planned by the study procedure and repeated 3 more times with an interval of 1 week (T2i, T3i and T4i).
Device: SUNEKOS ® Body
SUNEKOS ® Body is a medical device (class III). The study product was injected at level of the inner thighs, knees and arms by needle (29 G) using the interstitial fluid technique (IFT)
Change from baseline of inner arm skin laxity clinical grade
Skin laxity clinical grade, according to a visual score from 1 (no flaccidity) to 5 (very severe flaccidity)
Time frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner arm skin roughness clinical grade
Skin roughness clinical grade, according to a visual score from 1 (no roughness) to 5 (very severe roughness)
Time frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner thigh skin laxity clinical grade
Skin laxity clinical grade, according to a visual score from 1 (no flaccidity) to 5 (very severe flaccidity)
Time frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner thigh skin roughness clinical grade
Skin laxity clinical grade, according to a clinical score from 1 (no roughness) to 5 (very severe roughness)
Time frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner knee skin laxity clinical grade
Skin laxity clinical grade, according to a clinical score from 1 (no flaccidity) to 5 (very severe flaccidity)
Time frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of inner knee skin roughness clinical grade
Skin laxity clinical grade, according to a visual score from 1 (no roughness) to 5 (very severe roughness)
Time frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of superficial skin hydration
Skin electrical capacitance value was measured mono-laterally on the right or left inner arm, thigh and knee with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.
Time frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of deep skin hydration
Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the right or left inner arm, thigh and knee with MoistureMeterD (Delfin Technologies, Kuopio - Finland)
Time frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of skin density
A little skin area of about 7 cm2 (at level of inner arm was pinched, in standardized conditions, using a specific device. Because of this "pinch" the skin profile changes depending on cutaneous density; when the skin is slack the "pinch" forms a lot of wrinkles. A picture of the skin pinched was taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters.
Time frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Change from baseline of photographic documentation
2D pictures of the inner arm, thigh and knee
Time frame: baseline, 48 hours after the last injection procedure, after 8 weeks, after 16 weeks
Ran from May 2019 to primary completion in Sep 2019, 4 months.
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Derming SRL