Post-Market Clinical Follow-up (PMCF) Study of Safety and Performance of 300-01 RefillHA Lips

Glyance87 enrolled

Overview

A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips

This post-market, prospective, non-interventional, open label study is designed to demonstrate the performance and safety of RefillHA Lips in routine clinical practice for remodelling and correction of mild defects of the lips. Subjects over 18 years old, willing to undergo non-surgical aesthetic procedures with RefillHA Lips will be offered to participate in the study. The investigators will enroll in any subject who receives at least one injection with RefillHA Lips and have provided informed consent. They will follow their routine practice regarding injection technique, volume, and subject follow-up. Treatments will be performed for a single indication or for multiple indications where correction is requested, subject to the advice of the practitioner and in accordance with the product intended use and conditions. Any indication can be retreated at any time throughout the duration of the study, as per routine practice. The area to be treated and injection characteristics - volume, depth, and technique - are all left to the discretion of the practitioner. The study protocol includes an initial visit (baseline) and follow-up visits at months 1, 3, 6, 9, and 12 from baseline, in accordance with the non-interventional study design. Additional visits are allowed at any time throughout the follow-up period at the patient's request or when deemed necessary. At each visit, in addition to the safety assessment, performance will be evaluated through an area-specific assessment of the lips.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Mild Defects of the Lips

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men or women of any race, 18 years of age or older. * Able to read, understand and sign informed consent. Exclusion Criteria: * 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. * Previously treated with semi-permanent or permanent filler in the intended injection area. * Presenting with a cutaneous disorder, inflammation or infection near to the treatment area. * Known hypersensitivity to lidocaine and/or lidocaine HCl or hyaluronic acid. * Metabolic or endocrine uncontrolled disease, anaphylaxis, severe allergies or uncontrolled immune disorder. * Undergoing or planning to undergo peeling treatment or laser-/ultrasound-based treatment within 3 weeks before or after injection. * Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs such as aspirin, ibuprofen), or other substances known to prolong time of coagulation from a week before treatment. A wash-out period of a week is allowed. * Subject who has a condition or is in a situation that, in the investigator's opinion, may put the subject at significant risk, or may significantly interfere with the subject's participation in the study or with protocol evaluation parameters.

Locations (1)

Glyance Ltd

Lod, Israel, Israel

RECRUITING

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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