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

Wrinkle Clinical Trial

Official title:
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

Clinical Trial 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?

Clinical Trial 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; ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04650620
Study type Interventional
Source I.R.A. Istituto Ricerche Applicate S.p.A.
Contact
Status Completed
Phase N/A
Start date October 22, 2020
Completion date April 2, 2021
View Details
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