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:
2025-12-25 @ 4:37 AM
Ignite Modification Date:
2025-12-25 @ 4:37 AM
NCT ID:
NCT07188818
Brief Summary:
A post-market-clinical follow-up investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.
Detailed Description:
A post-market, open-label, prospective, interventional, confirmatory, evaluator-blinded, multi - centre, clinical investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.
Subjects desiring correction and improvement of their lip profile at the participating sites will be asked to participate in the clinical investigation. According to national legislation, all subjects must have a consultation with the respective clinic and receive both oral and written information at least 48 hours prior to treatment with fillers, as to allow for sufficient reflection time.
If the subject decides to participate, the subject will receive treatment on Day 0 (Visit 1). At 1 month visit (Visit 2) an optional touch-up may be given as well as assessments performed. All subjects will be followed for 6 months with follow-up and assessments by visits in the clinic (Visit 2, Visit 3 and Visit 4).
Standardized facial photography will be taken prior to and after treatment during Visit 1 and 2 and during each follow-up visit at the clinic (Visit 3, Visit 4 and Visit 5). The photographs will be used for the evaluation of the primary efficacy endpoint of the blinded-evaluator using the Global Aesthetic Improvement Scale (GAIS) as well as the exploratory instrumental evaluation of the lip contour. GAIS will be used for blinded-evaluator assessment, treating Investigator assessment and patient satisfaction.
Numeric Pain Rating Scale (NRS) at each visit involving an injection (Visit 1 and Visit 2 - optional touch up) will be used to measure pain.
Study:
NCT07188818
Study Brief:
Protocol Section:
NCT07188818