NCT05590364

Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: IBSA Farmaceutici Italia Srl · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 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.

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 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.

Conditions

• Skin Laxity
• Skin Roughness

Interventions

Type	Name	Description
DEVICE	Profhilo® Body	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.

Timeline

• Start date: 2022-11-07
• Primary completion: 2023-06-08
• Completion: 2023-06-08
• First posted: 2022-10-21
• Last updated: 2023-09-28

Locations

1 site across 1 country: Italy