A Post-Marketing Study of Alexa Medium for Сorrection of the Lips Volume Loss

NCT06961305 | Completed

• 1 other identifier: AL-MED/REG-21
• Study Type: interventional
• Target: 69
• Locations: 2 countries
• Sites: 4

Brief Summary

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. 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.

Conditions

Lip Volume Enhancement; Lip Augmentation; Aesthetic

Keywords

Aesthetic; Lip Volume; Alexa Medium

Outcome Measures

Primary Outcomes (2)

• Global Aesthetic Improvement Scale (GAIS) Score at Day 60

  Change in GAIS score from baseline to Day 60, as evaluated by the Investigator. GAIS is a 5-point scale ranging from 1 (exceptional improvement) to 5 (worsened patient).

  Day 60 ±5 days

• Medicis Lip Fullness Scale (MLFS) Score at Day 60

  hange in MLFS score from baseline to Day 60, as evaluated by the Investigator. MLFS is a 5-grade scale (1=very thin lips, 5=very full lips)

  Day 60 ±5 days

Study Arms (1)

Single Arm: Alexa Medium

EXPERIMENTAL

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.

Device: Cross-linked Hyaluronic Acid Gel

Interventions

Cross-linked Hyaluronic Acid Gel DEVICE

This intervention involves the injection of Alexa Medium, a sterile, cross-linked hyaluronic acid gel (17.5 mg/mL). The gel is administered into the mucous membrane of the lips for aesthetic restoration of lip volume loss. The product is supplied in a pre-filled 1 mL syringe and injected by a trained medical professional. One or two injections were administered per participant, with the second injection performed at the investigator's discretion at Visit 2. The device is manufactured by Diaco Biofarmaceutici S.r.l., Italy.

Single Arm: Alexa Medium

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject's age 25 to 70.
• Subject will receive an injection of the medical device 'Alexa Medium' manufactured by Diaco Biofarmaceutici S.r.l., Italy for correction of the lips volume loss within accepted cosmetological practice.
• Subject's lips requiring correction of the lips volume loss according to the Investigator's judgement.
• The subject has established a realistic aesthetic improvement goal that the Investigator agrees is achievable, i.e., have realistic expectations of aesthetic results.
• Subject willing to have photographs of the face taken.
• Subject psychologically able to understand the Investigation related information and to give a written informed consent.
• Subject able and agreeing to follow Investigation procedures, instructions and likely to complete all required visits.
• The subject agreed to participate in the Investigation and signed the Informed Consent Form.

You may not qualify if:

• Subject's age less than 25 or more than 70.
• Subject tends to develop hypertrophic scarring.
• Subjects has known hypersensitivity to cross-linked hyaluronic acid.
• Subjects has history of severe and/or multiple allergies.
• Subjects has history of herpetic rash.
• Subject has impaired haemostatic function.
• Subject is on anticoagulant medication(s) or is using substances that can prolong bleeding.
• Subject has present or past history of autoimmune disease or autoimmune deficiency.
• Subject is undergoing immunosuppressive therapy.
• Subject has acute rheumatic fever with heart complications.
• Subject has tumour in area of the IMD application.
• Subject has active tuberculosis.
• Subject with presence of any other chronic disease that in the opinion of the Investigator may interfere with the outcome of the Investigation.
• Subject is a pregnant or breastfeeding women.
• Subject is presenting with cutaneous inflammatory and/or infectious diseases (acne, herpes, etc.) in area of the IMD application.

Sponsors & Collaborators

• Institute Hyalual GmbH: lead

Study Sites (4)

Provita Sp. z o.o.

Katowice, 40-611, Poland

Location

Ośrodek medyczny OSTEOMED s.c.

Krakow, 30-074, Poland

Location

Ostrowieckie Centrum Medyczne

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Institute Hyalual LLC

Kyiv, 03151, Ukraine

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: August 10, 2021
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: May 6, 2026

Record last verified: 2025-05

Locations

PL (3); UA (1)