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| Name | Class |
|---|---|
| Derming SRL | OTHER |
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People lose collagen all over the body, not just in the face; skin roughness and laxity of the dorsum of the hands can result from chrono and photo-aging. This skin roughness and laxity can range from very mild to severe; injection procedures can provide new tone and firmness to the skin of the hand dorsum. Dermal fillers are the most used non-permanent injectable materials available today to correct skin flaccidity and roughness on the dorsum of the hands. They give immediate aesthetic effect due to elastic gel matrix injected and impart longer term effects due to bio stimulation, promoting new collagen formation. The objective of this study is to investigate the aesthetic performance of the Hyaluronic acid (HA)- based dermal filler Profhilo® Body injected by a blunt tip microcannula (25G or 22G, preferably 22G), with fanning technique through a single entry point performing 5 passages and injecting 0,3 ml per passage, 1,5 ml for each hand. Volunteers of both sexes, aged 18-65 years with mild-moderate skin roughness and laxity at the level of hand dorsum are to be treated.
Open, monocentric. 3 visits, 55 subjects.
Primary endpoint of the study is the evaluation of performance and tolerance of Profhilo Body (3ml) treatment in the back of the hands ( or dorsum of the hands). Secondary endpoint is self-assessment questionnaire by both doctors and volunteers.
Profhilo® Body (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 3.25 ml non-pyrogenic pre-filled syringe, containing 3 ml of 3.2% hyaluronic acid for intradermal use (48 mg H-HA + 48 mg L-HA) dissolved in 3 ml of saline buffered sodium chloride. - IBSA Farmaceutici Italia S.r.l. - ITALY. The principle component is cross-linked Hyaluronic Acid of non-animal origin, produced by bacterial fermentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Profhilo® Body treatment group | Experimental | 1.5 ml per hand injected by a blunt tip microcannula (25G or 22G, preferably 22G), with fanning technique through a single entry point performing 5 passages and injecting 0,3 ml per passage. Day 0: Information and consent form provided. Clinical photography, Clinical assessment, Instrumental assessment, First treatment of Profhilo® (refer to study protocol). Day 30 (1 month after day 0): Clinical photography, Clinical assessment, Instrumental assessment, Second treatment of Profhilo® (refer to study protocol), Self-evaluation questionnaire. Day 120 (4 months after day 0): Clinical photography, Clinical assessment, Instrumental assessment, NO treatment, Self-evaluation questionnaire. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Profhilo® Body | Device | Dosage form: Profhilo® Body (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 3.25 ml non-pyrogenic pre-filled syringe, containing 3 ml of 3.2% hyaluronic acid for intradermal use (48 mg H-HA + 48 mg L-HA) dissolved in 3 ml of saline buffered sodium chloride. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline of Skin Roughness and flaccidity at 30 days and at 120 days post-injection | Visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity) | Day 0, Day 30, Day 120 |
| Change from Baseline of Skin density (profilometry) at 30 days and at 120 days post-injection | A picture of the skin is taken thanks to Primos compact portable device (GFMesstechnik) and a 3D representation is elaborated by Primos software. | Day 0, Day 30, Day 120 |
| Change from Baseline of Superficial and deep skin plastoelasticity at 30 days and at 120 days post-injection | Measurement of the principal torsiometric parameters Ue (immediate extensibility), Uf (final extensibility), Uv (viscoelasticity) and Ur (immediate elastic recovery) by the instrument Dermal Torque Meter (Dia-Stron Ltd., UK) | Day 0, Day 30, Day 120 |
| Change from Baseline of Tissue dielectric constant value of superficial and deep skin layers at 30 days and at 120 days post-injection | Non-invasive measurements of dielectric constant of the skin and subcutaneous fat by MoistureMeterD (Delfin Technologies, Kuopio - Finland). MoistureMeterD measures the changes in the total water content in the tissue with 0.5mm and 1.5mm probes. | Day 0, Day 30, Day 120 |
| Change from Baseline of Photographic evaluation at 30 days and at 120 days post-injection | 2D pictures of the dorsum of both hands are taken in order to support the aesthetic result assessment | Day 0, Day 30, Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy questionnaire | Self-assessment questionnaire regarding skin roughness and laxity of the treated areas, skin suppleness, skin smoothness, skin hydration, skin lifting, contour redefinition/remodeling (score: very marked; marked; medium; light; absent) | Day 30, Day 120 |
| Treatment tolerance questionnaire |
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Inclusion Criteria: Will be included in the study volunteers with the following characteristics:
Exclusion Criteria:
Exclusion criteria due to systemic disease:
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| Name | Affiliation | Role |
|---|---|---|
| Adele Sparavigna, MD | DERMING S.r.l., Clinical Research and Bioengineering Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DERMING S.r.l., Clinical Research and Bioengineering Institute | Milan | Lombardy | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2022 | Oct 13, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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55 subjects undergoing Profhilo Body treatment in the back of the hands, 3 visits: Day 0 (treatment) Day 30 (1 month after Day 0 treatment) Day 120 (4 months after Day 0 - follow-up).
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No masking
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Self-assessment score: bad; poor; good; excellent |
| Day 30, Day 120 |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |