Post-Market Clinical Follow-up (PMCF) Study of Safety and Performance of 300-01 RefillHA Lips
ConditionMild Defects of the Lips
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGlyance
About this trial
A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women of any race, 18 years of age or older.
Able to read, understand and sign informed consent.
Disqualifiers
Subjects with known contraindications to the treatment with RefillHA Lips, as per the device IFU.
Patients with multiple and/or severe allergies or history of anaphylaxis.
Pregnant or lactating women (contraindications as per IFU).
Having received prior dermal filler injections in the six months preceding the study.
Trial population
Subjects over the age of 18 who are seeking remodelling and/or correction of mild defects of the lips.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
87 Participants
are grouped into 1 trial groupGroup A: Subjects over 18 years old, willing to undergo non-surgical aesthetic procedures with RefillHA Lips
Trial outcomes
Primary outcomes
1
Primary endpoint
The proportion of subjects with Global Aesthetic Improvement Scale (GAIS) scores 1-3 (responders) in the lips at months 6, 9 and 12 after initial injection, as assessed by the investigator (iGAIS). \[Scores 1-3 correspond to 'Very much improved', 'Much improved', and 'Improved' (see Section 12.1).\]
Time frame
Up to 56 weeks after treatment Source ClinicalTrials.gov