NCT04650620

Study to Evaluate the Performance and Safety of the Medical Device Plenhyage®

Open, Non-comparative Study to Evaluate the Performance and Safety of the Medical Device Plenhyage® (Polymerized Polynucleotides Dermal Filler) in the Correction of Wrinkles and Improving the Skin Tones and Irregularities (Atrophies) of the Skin Surface in Neck, Abdomen, Thighs, and Buttocks

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: I.R.A. Istituto Ricerche Applicate S.p.A. · Network
• Sex: All
• Age: 30 Years – 67 Years
• Healthy volunteers: Accepted

Summary

The Research Question of the present study is the following: in a population of men and women affected by face wrinkles and skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks, will Plenhyage® significantly decrease the appearance of treated areas, results observed after 8 and 12 weeks?

Detailed description

Open, non-comparative, interventional, multicenter study with the total number of screened subjects of 66 (60 evaluable subjects +6 potential screening failure): * 20 patients will be administered Plenhyage® thin for the treatment of mild wrinkles; * 20 patients will be administered Plenhyage® medium for the treatment of moderate wrinkles; * 20 patients will be administered Plenhyage® strong for improving the skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks;

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	Plenhyage® thin	0.75%
DEVICE	Plenhyage® medium	2%
DEVICE	Plenhyage® strong	2.5%

Timeline

• Start date: 2020-10-22
• Primary completion: 2021-04-02
• Completion: 2021-04-02
• First posted: 2020-12-02
• Last updated: 2021-04-12

Locations

1 site across 1 country: Romania