Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT05747456
Brief Summary:
The primary objective of the study is to demonstrate the superiority of IPN-21-SENSE versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.
Detailed Description:
This is a prospective, randomized, no-treatment controlled clinical trial of a proposed class III medical device. This study is designed to demonstrate clinical safety and performance of the IPN-21-SENSE dermal filler in the restoration or creation of volume in the mid-face.
The objective of this study is to demonstrate the superiority of IPN-21-SENSE versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.
Assessment of superiority will be based on 3D analysis of the volumetric change, using a validated imaging system.
Effectiveness of IPN-21-SENSE will be demonstrated if the mean volumetric change at 24 weeks after baseline from pre-treatment in the treatment group is statistically superior to the mean change in the delayed treatment (control) group.
In total, approximately 90 subjects will be enrolled across two study centers in France and Poland.
Subjects will be randomized to the treatment group or delayed treatment (control) group at a 5:1 ratio (i.e., there will be 5 more subjects treated with IPN-21-SENSE at baseline as compared to subjects who will be in the no-treatment (control) group and who will receive a delayed treatment with IPN-21-SENSE at 24 weeks after baseline).
The total duration of subject participation ranges from 18 months (treatment group) to 24 months (delayed treatment (control) group). Overall study duration including the enrolment period is expected to take approximately 30 months.
Study:
NCT05747456
Study Brief:
Protocol Section:
NCT05747456