Official Title
An Open-label Uncontrolled Single Centre Investigation for the Evaluation of the Safety and Performance Characteristics of the Dermal Filler, of Hyaluronic Acid 20 mg/ml, (M-AOX-2021) for Soft Tissue Augmentation Intended to be Used as a Temporary Dermal Filler for the Correction of Mild and Moderate Facial Wrinkles.
Brief Summary

The investigation is a single centre, interventional, prospective, non-randomized,open-label, uncontrolled, single arm, un-blinded investigation for evaluation of safetyand performance of the medical device M-AOX-2021 in the treatment of wrinkles andimperfections. The clinical investigation is interventional and prospective in agreementwith the pre-market regulatory status of the product.

Detailed Description

The product M-AOX-2021 is a dermal filler manufactured by mesoestetic Pharma Group s.l..
It was intended to be used as a temporary dermal filler for dermatological treatment for
aesthetic purposes. The product corrects wrinkles and imperfections of the lower two
thirds of the face, while also providing hydration and an antioxidant action to the skin.

Мesofiller aox for facial area is a sterile, injectable, gel colourless, transparent,
non-pyrogenic, reabsorbable medical device made out of cross-linked hyaluronic acid of
non-animal origin, produced via bacterial fermentation.

This clinical investigation was conducted as an uncontrolled - no comparator medical
device or other product was used. The safety and performance of the treatment was
evaluated by comparison of the condition with the state of the treated area before
initiation of the procedure, conducted by the trained Principal Investigator.

The investigated product M-AOX-2021 was applied by intradermal or subcutaneous injection
by the investigator during Session 1 for all subjects and Session 2 for the subjects, for
whom a touch-up was considered beneficial. The both sessions was conducted within 14 days
interval.

The process of the evaluation during the medical examination was facilitated by
photographic evidence taken before and after therapy at a predetermined time points for
reference.

Completed
Skin Aging
Skin Wrinkling

Device: mesofiller aox

The investigated product M-AOX-2021 was applied by intradermal or subcutaneous injection
by the investigator during Session 1 for all subjects and Session 2 for the subjects, for
whom a touch-up was considered beneficial. The both sessions was conducted within 14 days
interval.

Eligibility Criteria

Inclusion Criteria:

- Male or female subjects aged ≥20 and ≤70 years;

- Subjects presenting signs of skin depressions, scars or wrinkles in the lower two
thirds of the face;

- Aesthetic scores of 2, 3 or 4 (mild, moderate or substantial loss of midface
fullness, respectively) on each side of the face assessed at baseline by the
investigator;

- Subject who is willing to abstain from any other facial aesthetic or cosmetic
procedure or plastic surgery during the clinical investigation, including follow-up
period;

- Subject who understands and is willing to comply with all investigation-related
activities and who is available for the duration of their participation in the
investigation, including follow-up;

- Absence of a history of significant hypersensitivity to food and drugs or known
sensitivity to hyaluronic acid, lidocaine or other anesthetics or nerve-blocking
agents;

- Arterial blood pressure (BP) (after 5 min. at rest in the supine position) in
reference range - systolic 90 - 140 mmHg and diastolic 50 - 90 mmHg;

- Heart rate (HR) (after 5 min. at rest in the supine position) in reference range -
over 50 beats/min and less than 100 beats/min;

- Axillar body temperature of up to 37°С;

- Clinical-laboratory examinations within the reference ranges or with no clinically
significant abnormalities for CBC, ESR, PT/INR;

- Negative pregnancy test for the women with reproductive potential;

- Reliable and acceptable method of contraception for the women of child-bearing
potential:

- IUD, inserted at least 3 months prior to the investigation initiation;

- Double barrier method (condom, spermicide-containing diaphragm) applied at
least 14 days prior to the first investigated product application and
throughout the course of the investigation;

- Hormonal contraception with use initiation at least 3 months prior to the first
investigated product application and throughout the course of the
investigation;

- Sexual abstinence for at least 14 days prior to enrollment into the
investigation and throughout the course of the investigation;

- Surgical sterilisation (bilateral ligation of the uterine tubes, hysterectomy,
bilateral ovariectomy or vasectomy of the regular partner) with no less than a
6-month history;

- Menopause with no less than a 2-year history prior to the investigation
initiation.

- Signed written Informed Consent Form by the adult participant.

Exclusion Criteria:

- Subject with known severe or multiple allergies, including allergy or
hypersensitivity to any of the DF components (HA, lidocaine, succinic acid, ascorbyl
glucoside, idebenone) or other anesthetics or nerve-blocking agents,or significant
allergy or hypersensitivity to food and drugs;

- History of any disease resulting in changes of facial contour or oedema of the face
during the clinical investigation period;

- Ascertained tendency to develop hypertrophic or keloid scars or pigmentation
disorders;

- History of connective tissues diseases;

- History of active autoimmune diseases or those under immunotherapy;

- History of or laboratory results suggesting coagulation disorder;

- Active skin disease or inflammation of or near the injection area that could
interfere with the clinical investigation injections or assessments;

- Subject who suffers from another medical condition or who is receiving medication
that in the Principal Investigator's judgment would prohibit inclusion in this
investigation;

- Soft tissue augmentation with bovine collagen (in the previous 6 months), with
porcine or human collagen (in the previous 12 months), or with hyaluronic acid or
hydroxyapatite (in the previous 18 months);

- Subject with permanent implants in the neck or face within the previous 36 months;

- Any aesthetic treatment/procedure of the face in the previous 6 months that may
interfere with the investigation's injections and/or investigation assessments, as
judged by the investigator;

- Presence of any condition, which in the opinion of the investigator, makes the
subject unable to complete the clinical investigation as per this CIP;

- Subject who is currently participating in another clinical investigation which may
interfere with this clinical investigation results or who had participated in
another clinical investigation within 30 days prior to enrollment in this
investigation;

- Pregnancy, postpartum period (6 months), lactation or post-lactation period (6
months) or woman who plans pregnancy during the investigation follow-up period;

- Absence of a reliable and effective method of contraception for subject with
childbearing potential;

- Known abuse of drugs, alcohol or other substances;

- Subject with limited mental and consistent comprehension abilities; incapacitated
subjects; sportsmen and individuals on strenuous physical loading; prisoners;

- Refusal to sign the Informed Consent Form by the adult participant.

Eligibility Gender
All
Eligibility Age
Minimum: 20 Years ~ Maximum: 70 Years
Countries
Bulgaria
Locations

"Medical Center Ramus" EOOD
Sofia 727011, Bulgaria

Not Provided

Mesoestetic Pharma Group S.L.
NCT Number