An interventional study of Profhilo® in Skin Manifestations, 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 2019-07-18.
Sponsored by Derming SRL · Not applicable, Interventional, and Treatment
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The objective of this study is to investigate the aesthetic performance of the Hyaluronic acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique ("BAP" techinique ) in woman aged 40-65 years with skin flaccidity and roughness of the neck.
29 studies on the registry are indexed under Skin Manifestations; 5 are open to participants now.
This study's enrollment of 25 is below the median of 75 across 23 interventional studies indexed under Skin Manifestations.
Browse Skin Manifestations studies →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 after 1 month (T1). 2 mL of Profhilo® was injected into the middle-deep dermis by needle (29 G) using a bolus technique called "BAP" (Bio Aesthetic Point technique); this technique involves a series of 10 micro-wheals on 3 vertical-lines (3-4-3 ). The amount of product injected was 0.2 ml for each injection point.
Device: Profhilo®
Profhilo® (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 2.25 ml non-pyrogenic pre-filled syringe, containing 2 ml of 3.2% hyaluronic acid for intradermal use (32 mg H-HA + 32 mg L-HA dissolved in 2 ml of saline buffered sodium chloride
Change from baseline of neck skin roughness and laxity clinical grade
Skin roughness and laxity clinical grade, according to a visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity).
Time frame: Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of superficial skin hydration
Skin electrical capacitance value was measured mono-laterally on the neck 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 (T0), 1 month (T1), 4 months (T2)
Change from baseline of deep skin hydration
Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the neck with MoistureMeterD (Delfin Technologies, Kuopio - Finland)
Time frame: Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of skin density
A little skin area of about 7 cm2 at level of neck 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 (T0), 1 month (T1), 4 months (T2)
Change from baseline of skin plastoelasticity
Superficial and deep skin plastoelasticity was measured mono-laterally on the neck with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK).
Time frame: Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of photographic documentation
2D pictures of the neck
Time frame: Baseline (T0), 1 month (T1), 4 months (T2)
Ran from Feb 2019 to primary completion in Jun 2019, 4 months.
Of 14 interventional studies with no phase under Skin Manifestations, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 17. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Derming SRL