A Post-Marketing Study of Alexa Medium for Lip Volume Restoration in Adult Women (ALMED)

Institute Hyalual GmbH

Status: Completed

Conditions: Lip Augmentation; Aesthetic; Lip Volume Enhancement

Treatments: Device: Cross-linked Hyaluronic Acid Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT06961305

AL-MED/REG-21

Details and patient eligibility

About

This post-marketing, prospective, multicentre, single-arm, open-label clinical investigation aimed to evaluate the safety, tolerability, and effectiveness of the injectable medical device Alexa Medium (based on cross-linked hyaluronic acid) for the correction of lip volume loss in adult women. Participants received one or two injections of the product, and effectiveness was assessed using the Global Aesthetic Improvement Scale (GAIS) and the Medicis Lip Fullness Scale (MLFS). Safety data were collected at each visit. The study demonstrated high effectiveness and safety, with most subjects achieving their personal aesthetic goals.

Enrollment: 69 patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female participant aged 25 years or older.
• Subject seeking correction of lip volume loss with Alexa Medium as judged appropriate by the Investigator.
• Subject has realistic aesthetic goals for lip enhancement, agreed upon with the Investigator.
• Subject is willing to have standardized facial photographs taken.
• Subject is psychologically capable of understanding study-related information and providing written informed consent.
• Subject is able and willing to comply with the investigation schedule, procedures, and requirements.
• Subject has signed the Informed Consent Form before any study-related procedure.

Exclusion criteria

• History of hypertrophic scarring or keloid formation.
• Known hypersensitivity to cross-linked hyaluronic acid or any component of the product.
• History of severe and/or multiple allergies.
• Active or recurrent herpetic lesions.
• Impaired haemostatic function or use of anticoagulant therapy.
• Current or past autoimmune disease or immunodeficiency.
• Ongoing immunosuppressive treatment.
• History of acute rheumatic fever with cardiac complications.
• Tumors in the area of planned injection.
• Active tuberculosis.
• Any chronic disease that, in the Investigator's opinion, may interfere with the study.
• Pregnancy or breastfeeding.
• Inflammatory or infectious skin diseases (e.g., acne, herpes) in the treatment area.
• Planned or recent laser treatment, deep chemical peels, or dermabrasion.
• Presence of a permanent implant in the treatment area.
• Prior injection of more than 18 mL of dermal fillers per 60 kg body weight per year.
• Inability or unwillingness to comply with study procedures.
• Inability to understand the language of informed consent.
• Suspected body dysmorphic disorder or psychological condition affecting consent or participation.
• Participation in another clinical investigation concurrently.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

69 participants in 1 patient group

Single Arm: Alexa Medium

Experimental group

Description:

Participants received one or two injections of Alexa Medium, a cross-linked hyaluronic acid gel, into the mucous membrane of the lips for aesthetic correction of lip volume loss. The second injection was optional and performed at the discretion of the investigator during the second visit.

Treatment:

Device: Cross-linked Hyaluronic Acid Gel