Ignite Creation Date:
2024-05-06 @ 6:14 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05590364
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2022-09-27
Brief Title:
Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands
Sponsor:
IBSA Farmaceutici Italia Srl
Organization:
IBSA Farmaceutici Italia Srl
Study Overview
Official Title:
Interventional Post-marketing Local Mono-centric Study for Evaluation of Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 03 ml per passage 15 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
Detailed Description:
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 Srl is a resorbable medical device 325 ml non-pyrogenic pre-filled syringe containing 3 ml of 32 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 Srl - ITALY The principle component is cross-linked Hyaluronic Acid of non-animal origin produced by bacterial fermentation
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 Srl is a resorbable medical device 325 ml non-pyrogenic pre-filled syringe containing 3 ml of 32 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 Srl - ITALY The principle component is cross-linked Hyaluronic Acid of non-animal origin produced by bacterial fermentation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None