Lip Volume EnhancementAL-MEDNCT06961305
A Post-Marketing Study of Alexa Medium for Сorrection of the Lips Volume Loss
A study testing Cross-linked Hyaluronic Acid Gel in people with Lip Volume Enhancement and Lip Augmentation, run by Institute Hyalual GmbH at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lip Volume Enhancement, Lip Augmentation, Aesthetic
- What is being tested?
- Cross-linked Hyaluronic Acid Gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 10 Aug 2021to 2 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
- Subject plans laser correction, deep chemical peels or dermabrasion during the potential participation in this Investigation.
- Subject has undergone recently laser correction, deep chemical peels, dermabrasion or surface peels, so the inflammatory reaction from the peel is significant.
- Subject has a permanent implant in the area of the IMD application.
- Subject has already injected more than 18 mL of dermal fillers per 60 kg of body mass per year.
- Subject refuses or is suspected of inability to comply with the requirements of the CIP.
- Subject has difficulty understanding the language in which the informed consent is written.
- Any other reason that the Investigator believes prevents the subject from participating in the Investigation (including suspicion of body dysmorphic disorder).
- Subject takes part in the other Investigation.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Poland3 sites
Provita Sp. z o.o.
Katowice, 40-611
Ośrodek medyczny OSTEOMED s.c.
Krakow, 30-074
Ostrowieckie Centrum Medyczne
Ostrowiec Świętokrzyski, 27-400
About this study
Official title: Post-Marketing, Prospective, Multicentre, Single-Arm, Open-Label Investigation of Alexa Medium for Correction of Lip Volume Loss Within Accepted Cosmetological Practice
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
- Being tested
- Cross-linked Hyaluronic Acid Gel
- Keywords
- Aesthetic, Lip Volume, Alexa Medium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-linked Hyaluronic Acid GelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cross-linked Hyaluronic Acid Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: Day 60 ±5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start10 Aug 2021
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lip Volume EnhancementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute Hyalual GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961305
- Sponsor's protocol ID
- AL-MED/REG-21
- Acronym
- AL-MED
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing, Prospective, Multicentre, Single-Arm, Open-Label Investigation of Alexa Medium for Correction of Lip Volume Loss Within Accepted Cosmetological Practice
- ClinicalTrials.gov ID
- NCT06961305
- Acronym / sponsor ID
- AL-MED / AL-MED/REG-21
- Conditions
- Lip Volume Enhancement, Lip Augmentation, Aesthetic
- Keywords
- Aesthetic, Lip Volume, Alexa Medium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Institute Hyalual GmbHIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Alexa Medium | Experimental | Device: Cross-linked Hyaluronic Acid GelParticipants 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-linked Hyaluronic Acid GelThis 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. | Device | Single Arm: Alexa Medium |
Primary outcome
Global Aesthetic Improvement Scale (GAIS) Score at Day 60
Time frame: Day 60 ±5 days
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).
Medicis Lip Fullness Scale (MLFS) Score at Day 60
Time frame: Day 60 ±5 days
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-linked Hyaluronic Acid Gel in people with Lip Volume Enhancement and Lip Augmentation, run by Institute Hyalual GmbH at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Aesthetic Improvement Scale (GAIS) Score at Day 60 (time frame: Day 60 ±5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.