Status:
COMPLETED
A Post-Marketing Study of Alexa Medium for Сorrection of the Lips Volume Loss
Lead Sponsor:
Institute Hyalual GmbH
Conditions:
Lip Volume Enhancement
Lip Augmentation
Eligibility:
All Genders
25-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
August 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2022
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06961305
Start Date
August 10 2021
End Date
June 2 2022
Last Update
June 10 2025
Active Locations (4)
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1
Provita Sp. z o.o.
Katowice, Poland, 40-611
2
Ośrodek medyczny OSTEOMED s.c.
Krakow, Poland, 30-074
3
Ostrowieckie Centrum Medyczne
Ostrowiec Świętokrzyski, Poland, 27-400
4
Institute Hyalual LLC
Kyiv, Ukraine, 03151