Skin AgingM-INT-LSNCT06451822
Efficacy and Performance Evaluation of mIntense L+AS 25 mg/ml Hyaluronic Acid for the Correction of Moderate to Deep Wrinkles and Folds
A study testing mIntense L+AS in people with Skin Aging and Skin Wrinkling, run by Mesoestetic Pharma Group S.L. at 1 site in Bulgaria.
Trial summary
The investigation is a single-centre, interventional, prospective, non-randomized, open-label, uncontrolled, single-arm, un-blinded investigation for evaluation of the safety and performance of the product mIntense L+AS in the treatment of small skin defects, such as wrinkles or scars. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Skin Wrinkling
- What is being tested?
- mIntense L+AS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBulgaria
- Study dates
- 3 Feb 2022to 31 Jul 2023
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥18 and ≤70 years;
- Subjects showing signs of facial skin depressions, scars or deep wrinkles;
- Aesthetic scores of 3 or 4 (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;
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- 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;
- 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.
Who cannot join
- Subject with known serious multiple allergies, sensitivity to any of the active ingredients (hyaluronic acid, lidocaine) 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;
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- 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 investigations 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);
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Uncontrolled Single Centre Investigation for the Evaluation of the Safety and Performance Characteristics of the Dermal Filler mIntense L+AS, Hyaluronic Acid 25 mg/ml (M-INT-LS) for Soft Tissue Augmentation to Correction of Moderate to Deep Wrinkles and Folds
The investigation is a single-centre, interventional, prospective, non-randomized, open-label, uncontrolled, single-arm, un-blinded investigation for evaluation of the safety and performance of the product mIntense L+AS in the treatment of small skin defects, such as wrinkles or scars. The clinical investigation is interventional and prospective in agreement with the pre-market regulatory status of the product.
Read the detailed description
The product mIntense L+AS is a dermal filler manufactured by mesoestetic Pharma Group s.l. It was intended to be used as a temporary filler to correct small skin defects, such as wrinkles or scars. In particular, it was recommended for the treatment of deep wrinkles.
mIntense L+AS for the facial area is a sterile, injectable, gel colourless, transparent, non-pyrogenic, reabsorbable product containing cross-linked hyaluronic acid of non-animal origin, produced via bacterial fermentation.
This clinical investigation was conducted as an uncontrolled - no comparator was used. The safety and performance of the treatment were 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 mIntense L+AS 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. Both sessions were conducted within 14-day intervals.
The evaluation process during the medical examination was facilitated by photographic evidence taken before and after therapy at predetermined time points for reference.
- Conditions
- Skin Aging, Skin Wrinkling
- Being tested
- mIntense L+AS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mIntense L+ASDevice
Also called M-INT-LS
The investigated dermal filler mIntense L+AS is intended to be used as a temporary filler, administered by intradermal or subcutaneous injections, to correct small skin defects, such as wrinkles or scars.
| Study group | Role | What they receive |
|---|---|---|
| mIntense L+AS | Experimental | The investigated product mIntense L+AS 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. Both sessions were conducted within 14 day intervals. Receives: Device: mIntense L+AS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of AEs, SAEs, ISRs, TEAEs
The safety evaluation of mIntense L+AS will also rely on participants' complaints, physical examination of BP, HR, body temperature
Measured: Two months after the first treatment (Session 3 (Day 60))
Secondary outcomes (8)
Wrinkle Severity Rating Scale (WSRS) - principal investigator evaluation
The absolute change in the Wrinkle Severity Rating Scale from baseline, evaluated by the PI based on photographs of the treated area. The scale ranges from grade 1 to 5, with grade 1 representing the best possible outcome.
Measured: Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Wrinkle Severity Rating Scale (WSRS) - patient evaluation
The absolute change in the Wrinkle Severity Rating Scale from baseline, evaluated by the patient. The scale ranges from grade 1 to 5, with grade 1 representing the best possible outcome.
Measured: Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Global Aesthetic Improvement Scale (GAIS) - principal investigator evaluation
Improvement in the Global Aesthetic Improvement Scale as evaluated by the PI based on the photographs of the treated area. GAIS ranges from grade 1 to 5, where grade 1 shows exceptional improvement.
Measured: Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Global Aesthetic Improvement Scale (GAIS) - patient evaluation
Improvement in the Global Aesthetic Improvement Scale as evaluated by the patient. GAIS ranges from grade 1 to 5, where grade 1 shows exceptional improvement.
Measured: Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Visual Analogous Scale (VAS) - principal investigator evaluation
The absolute change in the Visual Analogous Scale from baseline judged by the PI. VAS ranges from grade 0 to 10, where grade 10 is the best possible outcome.
Measured: Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Visual Analogous Scale (VAS) - patient evaluation
The absolute change in the Visual Analogous Scale from baseline judged by the patient. VAS ranges from grade 0 to 10, where grade 10 is the best possible outcome.
Measured: Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Subject satisfaction
The Patient's Questionnaire was utilised. The satisfaction survey grades range from 1 to 3, where grade 1 represents the highest satisfaction level.
Measured: Sessions 1 (Day 1), 2 (Day 14), 3 (Day 60), 4 (Day 180), 5 (Day 270) and 6 (Day 365)
Frequency and severity of AEs, SAEs, ISRs, TEAEs
The safety evaluation of mIntense L+AS will also rely on participants' complaints, physical examination of BP, HR, body temperature
Measured: Sessions 1 (Day 1), 2 (Day 14), 3 (Day 60), 4 (Day 180), 5 (Day 270) and 6 (Day 365)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start3 Feb 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoestetic Pharma Group S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451822
- Sponsor's protocol ID
- M-INT-LS-2021
- Acronym
- M-INT-LS
- Status last verified
- Jun 2024
- First submitted
- 29 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Uncontrolled Single Centre Investigation for the Evaluation of the Safety and Performance Characteristics of the Dermal Filler mIntense L+AS, Hyaluronic Acid 25 mg/ml (M-INT-LS) for Soft Tissue Augmentation to Correction of Moderate to Deep Wrinkles and Folds
- ClinicalTrials.gov ID
- NCT06451822
- Acronym / sponsor ID
- M-INT-LS / M-INT-LS-2021
- Conditions
- Skin Aging, Skin Wrinkling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mesoestetic Pharma Group S.L.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 11 Jun 2024 (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.
The investigation is a single-centre, interventional, prospective, non-randomized, open-label, uncontrolled, single-arm, un-blinded investigation for evaluation of the safety and performance of the product mIntense L+AS in the treatment of small skin defects, such as wrinkles or scars. The clinical investigation is interventional and prospective in agreement with the pre-market regulatory status of the product.
Detailed description
The product mIntense L+AS is a dermal filler manufactured by mesoestetic Pharma Group s.l. It was intended to be used as a temporary filler to correct small skin defects, such as wrinkles or scars. In particular, it was recommended for the treatment of deep wrinkles.
mIntense L+AS for the facial area is a sterile, injectable, gel colourless, transparent, non-pyrogenic, reabsorbable product containing cross-linked hyaluronic acid of non-animal origin, produced via bacterial fermentation.
This clinical investigation was conducted as an uncontrolled - no comparator was used. The safety and performance of the treatment were 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 mIntense L+AS 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. Both sessions were conducted within 14-day intervals.
The evaluation process during the medical examination was facilitated by photographic evidence taken before and after therapy at predetermined time points for reference.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| mIntense L+AS | Experimental | Device: mIntense L+ASThe investigated product mIntense L+AS 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. Both sessions were conducted within 14 day intervals. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female subjects aged ≥18 and ≤70 years;
- Subjects showing signs of facial skin depressions, scars or deep wrinkles;
- Aesthetic scores of 3 or 4 (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;
Key exclusion criteria (18 listed)
- Subject with known serious multiple allergies, sensitivity to any of the active ingredients (hyaluronic acid, lidocaine) 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;
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 |
|---|---|---|
| mIntense L+ASAlso: M-INT-LSThe investigated dermal filler mIntense L+AS is intended to be used as a temporary filler, administered by intradermal or subcutaneous injections, to correct small skin defects, such as wrinkles or scars. | Device | mIntense L+AS |
Primary outcome
Frequency and severity of AEs, SAEs, ISRs, TEAEs
Time frame: Two months after the first treatment (Session 3 (Day 60))
The safety evaluation of mIntense L+AS will also rely on participants' complaints, physical examination of BP, HR, body temperature
8 secondary outcomes
Wrinkle Severity Rating Scale (WSRS) - principal investigator evaluation
Time frame: Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Wrinkle Severity Rating Scale (WSRS) - patient evaluation
Time frame: Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Global Aesthetic Improvement Scale (GAIS) - principal investigator evaluation
Time frame: Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Global Aesthetic Improvement Scale (GAIS) - patient evaluation
Time frame: Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Visual Analogous Scale (VAS) - principal investigator evaluation
Time frame: Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Visual Analogous Scale (VAS) - patient evaluation
Time frame: Session 2 (Day 14); Session 3 (Day 60); Session 4 (Day 180); Session 5 (Day 270); and Session 6 (Day 365)
Subject satisfaction
Time frame: Sessions 1 (Day 1), 2 (Day 14), 3 (Day 60), 4 (Day 180), 5 (Day 270) and 6 (Day 365)
Frequency and severity of AEs, SAEs, ISRs, TEAEs
Time frame: Sessions 1 (Day 1), 2 (Day 14), 3 (Day 60), 4 (Day 180), 5 (Day 270) and 6 (Day 365)
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 11 Jun 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mIntense L+AS in people with Skin Aging and Skin Wrinkling, run by Mesoestetic Pharma Group S.L. at 1 site in Bulgaria.
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 19 inclusion and 18 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. 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?
Frequency and severity of AEs, SAEs, ISRs, TEAEs (time frame: Two months after the first treatment (Session 3 (Day 60))). 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 11 Jun 2024.