WrinkleNCT07331181
Evaluation of Performance and Safety of INNEA and INNEA AQUA for the Treatment of Cheek and décolletage Wrinkles
A study testing Innea, Innea Aqua in people with Wrinkle and Aging, run by Innate srl at 3 sites in Italy.
Trial summary
A Post-Market, Single-arm, Confirmatory Interventional Clinical Investigation to evaluate the Performance and Safety of INNEA and INNEA AQUA for the treatment of cheek and décolletage wrinkles Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- What is being tested?
- Innea, Innea Aqua
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Jun 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Informed consent form (ICF) signed;
- Female Subjects between 35 and 65 years old at the time of the signature of ICF;
- Subjects with at least 2 (shallow wrinkles) on the Lemperle Rating Scale requiring correction of cheek wrinkles and/or subjects requiring correction of décolletage wrinkles;
- Willingness to follow all study procedures, including attending all site visits, tests and examinations;
- Agreeing to present at each study visit without make-up;
- Willingness not to undergo other procedures involving aesthetic correction (e.g., ultrasound-based treatments, biomaterial implant, lifting, botulinum toxin injections, laser or intense pulsed light treatment, bio-stimulating treatment, chemical peeling, dermabrasion, fillers) during the entire study period;
- Willingness to follow indications to not be exposed to make-up for 12 hours after injection;
- Willingness to avoid prolonged exposure to sunlight and UV or using saunas or Turkish baths for one week after the injection.
Who cannot join
- Other - different - clinical conditions of the skin (i.e. rosacea,psoriasis, vitiligo, active eczema, severe scleroderma, severe acne and diagnosticated cancer with/without ongoing antitumor therapy); 2. Infectious or inflammatory processes near the area of intervention; 3. Presence of naevi in the area to be injected; 4. Ongoing use or exposure to benzalkonium chloride solutions; 5. Patients who tend to develop hypertrophic scarring; 6. Patients with a history of autoimmune disease or who are receiving immune therapy; 7. Patients who are known to be hypersensitive to hyaluronic acid; 8. Presence of cutaneous disease on the tested area, as lesions, malformations and recurrent facial/labial herpes; 9. Presence of tendon, bone or muscular implants near the areaof intervention; 10. Ongoing cutaneous allergies; 11. Known hypersensitivity to cheloids; 12. Allergy or contraindications to device components; 13. Allergy or contraindication to one of the components of local anesthetic (patch or cream); 14. Immune system illnesses; 15. Diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder); 16. Problems with coagulation or undergoing anticoagulant therapy; 17. Patients who are using substances that can prolong bleeding(such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin); 18. Current treatment with anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago), drugs able to influence the test results in the investigator opinion; 19. Known drug and/or alcohol abuse; 20. Mental incapacity that precludes adequate understanding or cooperation; 21. Any previous permanent and nonpermanent cutaneous treatment for aesthetic correction (e.g., ultrasound-based treatments, biomaterial implant, lifting, botulinum toxin injections, laser or intense pulsed light treatment, bio-stimulating treatment, chemical peeling, dermabrasion, fillers) within 6 months prior to study inclusion; 22. Active malignant neoplasm of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable); 23. Pregnancy or breastfeeding; 24. COVID-19 vaccination within one month prior to study inclusion; 25. Current participation in a similar study or during the previous 3 months.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
ASST degli Spedali Civili di Brescia
Brescia, Brescia, 25123
Francesca Vertua, +39 371/4106594, sperimentazioni.dermatologia@unibs.it
Pergiacomo Calzavara Pinton
- Recruiting
Campus Biomedico
Roma, Roma
Paolo Persichetti, +3906225418824, p.persichetti@policlinicocampus.it
Paolo Persichetti
- Recruiting
Humanitas Research Hospital
Rozzano, MI, 20089
Eleonora Fattizzo, +39 02 8224-4050, eleonora.fattizzo@humanitas.it
Antonio Costanzo
About this study
Official title: A Post-Market, Single-arm, Confirmatory Interventional Clinical Investigation to Evaluate the Performance and Safety of INNEA and INNEA AQUA for the Treatment of Cheek and décolletage Wrinkles
A Post-Market, Single-arm, Confirmatory Interventional Clinical Investigation to evaluate the Performance and Safety of INNEA and INNEA AQUA for the treatment of cheek and décolletage wrinkles
Read the detailed description
Investigational product:
INNEA and INNEA AQUA are CE-marked medical devices indicated for intradermal injections. In particular:
- INNEA is a sterile, biodegradable, isotonic, dermal filler. INNEA consists of high chain (1,0-1,5 x 106 Dalton) hyaluronic acid (HA), obtained from Streptococcus equip bacteria, formulated to a concentration of 20 mg/ml in a physiologic buffer. Each box contains one syringe of INNEA, two 30G 1⁄2" disposable sterile needles reserved for injection of INNEA and a product leaflet.
- INNEA AQUA is a sterile, biodegradable, isotonic, intradermal filler. INNEA AQUA consists of a calibrated mix of medium weight (1200 - 1500 KDalton) HA and a low weight (200 - 400 KDalton), obtained from Streptococcus equi bacteria, formulated to a concentration of 25 mg/ml in a physiologic buffer and trehalose. Each box contains one syringe of INNEA AQUA, two 30G 1⁄2" disposable sterile needles reserved for injection of INNEA AQUA and a product leaflet.
Indications:
in the physiological process of aging of the skin, the effects of which include inspissation of the horny layer (roughness and reduced radiance of the skin) and changes in the elastic fibers of the dermis (wrinkles),
- in the dermal tissue repair process, in cases of scar results following superficial cutaneous trauma (e.g., acne and chickenpox scars).
Study procedure:
This is a post-market confirmatory interventional clinical investigation aimed to enroll adult women requiring correction of cheek and/or décolleté wrinkles. The investigation will be useful to collect INNEA and INNEA AQUA performance/safety evidence.
Each Subject, after signing the Informed Consent Form (ICF), will enter into a screening phase during which the baseline tests will be conducted. If the Investigator is able to organize and perform all tests in the same day, the screening phase and the baseline visit (V0) may coincide, and the patient can be treated immediately after signing the ICF. For each Subject, 5 visits will be planned during which several assessments will be performed as described in the Flowchart.
At V0, the Investigator will collect demographic data (e.g., sex, age, weight), medical history (e.g., history of autoimmune disease, diabetes, etc.), current clinical condition, drug allergy history, and Fitzpatrick phototype (as per clinical practice) of the enrolled Subject.
At V0, according to the instructions for use (IFU), the enrolled patients will be treated with one of the two IPs:
- INNEA, three injections at one week interval.
- INNEA AQUA, three injections at one week interval.
Subjects can be treated in one or two of the following areas with one of the two IPs (which will be the same for the three injections planned):
- Cheek
- Décolletage Performance will be evaluated by the Investigator using the Lemperle Rating Scale (LRS) for cheek wrinkles at each visit, and the Global Aesthetic Improvement Scale (GAIS) for décolletage wrinkles at each post-treatment assessment. In addition, global aesthetic appearance of the face will be assessed through GAIS by the Investigator. Skin radiance and turgor will be evaluated by Subjects using a 5-Likert scale.
After each injection, the Investigator will record Subjects' pain intensity using the Numerical Rating Scale (NRS).
Safety will include assessment of vital signs and evaluation of possible cutaneous reactions at each visit. Adverse events, concomitant medications, and device deficiencies will be monitored during the entire duration of the study.
A 5-point Likert Scale will be used by Subjects to assess patient satisfaction with treatment at EOS visit (V4).
- Being tested
- Innea, Innea Aqua
- Keywords
- wrinkles, aging of the skin, Innea-2022
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innea, Innea AquaDevice
INNEA: one syringe contains 2.0 ml of non-pyrogenic gel. The gel is based on the following: sodium hyaluronate 20 mg/ml
INNEA AQUA: one syringe contains 2.0 ml of non- pyrogenic gel. The gel is based on sodium hyaluronate 25 mg/ml, trehalose
| Study group | Role | What they receive |
|---|---|---|
| Innea | Other | At visit 0 after collecting the required informations tha patients will be treat with INNEA or Innea Aqua.
Subjects can be treated in one or two of the following areas with one of the two IPs (which will be the same for the three injections planned):
* Cheek
* Décolletage Performance will be evaluated by the Investigator using the Lemperle Rating Scale (LRS) for cheek wrinkles at each visit, and the Global Aesthetic Improvement Scale (GAIS) for décolletage wrinkles at each post-treatment assessment. In addition, global aesthetic appearance of the face will be assessed through GAIS by the Investigator. Skin radiance and turgor will be evaluated by Subjects using a 5-Likert scale. Receives: Device: Innea, Innea Aqua |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lemperle Rating scale
To evaluate the performance of INNEA and INNEA AQUA for the treatment of cheek and décolletage wrinkles after 1 month from the last injection, the lamperle Rating scale will be used:
- The Lemperle Rating Scale (LRS) will be used to assess cheek wrinkles at V4 (1 month after the 3rd injection) by study product.
Measured: 1 month after the last injections
GAIS for improvement
The Global Aesthetic Improvement Scale (GAIS) scale will be used to assess improvement of décolletage wrinkles at V4 (1 month after the 3rd injection) by study product.
Measured: One month after the injections
Secondary outcomes (7)
Outcome for performance with Lemperle Rating scale (LRS)
- To evaluate the performance of INNEA and INNEA AQUA for the treatment of cheek wrinkles at each visit and décolletage wrinkles at each post-treatment assessment, the LRS (for cheek wrinkles) at each visit. This scale is used because is based on standardized 6-point (0-5) clinical tool used by dermatologists and plastic surgeons to assess the severity of facial wrinkles and folds, aiding in evaluating the effectiveness of injectable fillers and, anti-aging treatments. It measures wrinkles based on depth, ranging from 0 (no wrinkles) to 5 (extremely deep wrinkles/folds). The success is based on the % of improvement in the state of the wrinkles.
Measured: 1 month after the last injections
Outcome safety: evaluation of adverse events
To assess the safety and tolerability of INNEA and INNEA AQUA evaluation of the frequency of adverse events (AEs) and type
Measured: 1 month after the last injections
Performance with Gais
To evaluate the performance of INNEA and INNEA AQUA to improve aesthetic appearance of the face, the GAIS will be used at each post-treatment assessment.
Measured: 1 month after the last injections
Performance with Likert scale
To evaluate the performance of INNEA and INNEA AQUA to improve skin radiance and turgor of cheek and décolletage, a 5- Likert scale will be used at each visit.
Measured: 1 month after the last injections
Pain intensity evaluation with NRS scale
To evaluate pain intensity after injection of INNEA and INNEA AQUA, a Numerical Rating Scale (NRS) will be used at V0, V1, V2.
Measured: 1 month after the last injections
Patience Satisfaction with Likert
To evaluate patient satisfaction with INNEA and INNEA AQUA, a 5- Likert Scale will be used at the end of study (EOS).
Measured: 1 month after the last injections
Evaluation of performance with Gais, secondary endpoint
To evaluate the performance of INNEA and INNEA AQUA for the treatment of cheek wrinkles at each visit and décolletage wrinkles at each post-treatment assessment, the Gais at each visit will be used
Measured: 1 month after the injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jun 2023
- Primary completion30 Nov 2024
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innate srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 1Med
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331181
- Sponsor's protocol ID
- INNEA-2022
- Status last verified
- Apr 2026
- First submitted
- 16 Jul 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market, Single-arm, Confirmatory Interventional Clinical Investigation to Evaluate the Performance and Safety of INNEA and INNEA AQUA for the Treatment of Cheek and décolletage Wrinkles
- ClinicalTrials.gov ID
- NCT07331181
- Acronym / sponsor ID
- INNEA-2022
- Keywords
- wrinkles, aging of the skin, Innea-2022
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Innate srlIndustry (pharma, biotech, devices)
- Collaborators
- 1Med
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Jan 2026 (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.
A Post-Market, Single-arm, Confirmatory Interventional Clinical Investigation to evaluate the Performance and Safety of INNEA and INNEA AQUA for the treatment of cheek and décolletage wrinkles
Detailed description
Investigational product:
INNEA and INNEA AQUA are CE-marked medical devices indicated for intradermal injections. In particular:
- INNEA is a sterile, biodegradable, isotonic, dermal filler. INNEA consists of high chain (1,0-1,5 x 106 Dalton) hyaluronic acid (HA), obtained from Streptococcus equip bacteria, formulated to a concentration of 20 mg/ml in a physiologic buffer. Each box contains one syringe of INNEA, two 30G 1⁄2" disposable sterile needles reserved for injection of INNEA and a product leaflet.
- INNEA AQUA is a sterile, biodegradable, isotonic, intradermal filler. INNEA AQUA consists of a calibrated mix of medium weight (1200 - 1500 KDalton) HA and a low weight (200 - 400 KDalton), obtained from Streptococcus equi bacteria, formulated to a concentration of 25 mg/ml in a physiologic buffer and trehalose. Each box contains one syringe of INNEA AQUA, two 30G 1⁄2" disposable sterile needles reserved for injection of INNEA AQUA and a product leaflet.
Indications:
in the physiological process of aging of the skin, the effects of which include inspissation of the horny layer (roughness and reduced radiance of the skin) and changes in the elastic fibers of the dermis (wrinkles),
- in the dermal tissue repair process, in cases of scar results following superficial cutaneous trauma (e.g., acne and chickenpox scars).
Study procedure:
This is a post-market confirmatory interventional clinical investigation aimed to enroll adult women requiring correction of cheek and/or décolleté wrinkles. The investigation will be useful to collect INNEA and INNEA AQUA performance/safety evidence.
Each Subject, after signing the Informed Consent Form (ICF), will enter into a screening phase during which the baseline tests will be conducted. If the Investigator is able to organize and perform all tests in the same day, the screening phase and the baseline visit (V0) may coincide, and the patient can be treated immediately after signing the ICF. For each Subject, 5 visits will be planned during which several assessments will be performed as described in the Flowchart.
At V0, the Investigator will collect demographic data (e.g., sex, age, weight), medical history (e.g., history of autoimmune disease, diabetes, etc.), current clinical condition, drug allergy history, and Fitzpatrick phototype (as per clinical practice) of the enrolled Subject.
At V0, according to the instructions for use (IFU), the enrolled patients will be treated with one of the two IPs:
- INNEA, three injections at one week interval.
- INNEA AQUA, three injections at one week interval.
Subjects can be treated in one or two of the following areas with one of the two IPs (which will be the same for the three injections planned):
- Cheek
- Décolletage Performance will be evaluated by the Investigator using the Lemperle Rating Scale (LRS) for cheek wrinkles at each visit, and the Global Aesthetic Improvement Scale (GAIS) for décolletage wrinkles at each post-treatment assessment. In addition, global aesthetic appearance of the face will be assessed through GAIS by the Investigator. Skin radiance and turgor will be evaluated by Subjects using a 5-Likert scale.
After each injection, the Investigator will record Subjects' pain intensity using the Numerical Rating Scale (NRS).
Safety will include assessment of vital signs and evaluation of possible cutaneous reactions at each visit. Adverse events, concomitant medications, and device deficiencies will be monitored during the entire duration of the study.
A 5-point Likert Scale will be used by Subjects to assess patient satisfaction with treatment at EOS visit (V4).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Innea | Other | Device: Innea, Innea AquaAt visit 0 after collecting the required informations tha patients will be treat with INNEA or Innea Aqua. Subjects can be treated in one or two of the following areas with one of the two IPs (which will be the same for the three injections planned): * Cheek * Décolletage Performance will be evaluated by the Investigator using the Lemperle Rating Scale (LRS) for cheek wrinkles at each visit, and the Global Aesthetic Improvement Scale (GAIS) for décolletage wrinkles at each post-treatment assessment. In addition, global aesthetic appearance of the face will be assessed through GAIS by the Investigator. Skin radiance and turgor will be evaluated by Subjects using a 5-Likert scale. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient Informed consent form (ICF) signed;
- Female Subjects between 35 and 65 years old at the time of the signature of ICF;
- Subjects with at least 2 (shallow wrinkles) on the Lemperle Rating Scale requiring correction of cheek wrinkles and/or subjects requiring correction of décolletage wrinkles;
- Willingness to follow all study procedures, including attending all site visits, tests and examinations;
- Agreeing to present at each study visit without make-up;
Key exclusion criteria (1 listed)
- Other - different - clinical conditions of the skin (i.e. rosacea,psoriasis, vitiligo, active eczema, severe scleroderma, severe acne and diagnosticated cancer with/without ongoing antitumor therapy); 2. Infectious or inflammatory processes near the area of intervention; 3. Presence of naevi in the area to be injected; 4. Ongoing use or exposure to benzalkonium chloride solutions; 5. Patients who tend to develop hypertrophic scarring; 6. Patients with a history of autoimmune disease or who are receiving immune therapy; 7. Patients who are known to be hypersensitive to hyaluronic acid; 8. Presence of cutaneous disease on the tested area, as lesions, malformations and recurrent facial/labial herpes; 9. Presence of tendon, bone or muscular implants near the areaof intervention; 10. Ongoing cutaneous allergies; 11. Known hypersensitivity to cheloids; 12. Allergy or contraindications to device components; 13. Allergy or contraindication to one of the components of local anesthetic (patch or cream); 14. Immune system illnesses; 15. Diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder); 16. Problems with coagulation or undergoing anticoagulant therapy; 17. Patients who are using substances that can prolong bleeding(such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin); 18. Current treatment with anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago), drugs able to influence the test results in the investigator opinion; 19. Known drug and/or alcohol abuse; 20. Mental incapacity that precludes adequate understanding or cooperation; 21. Any previous permanent and nonpermanent cutaneous treatment for aesthetic correction (e.g., ultrasound-based treatments, biomaterial implant, lifting, botulinum toxin injections, laser or intense pulsed light treatment, bio-stimulating treatment, chemical peeling, dermabrasion, fillers) within 6 months prior to study inclusion; 22. Active malignant neoplasm of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable); 23. Pregnancy or breastfeeding; 24. COVID-19 vaccination within one month prior to study inclusion; 25. Current participation in a similar study or during the previous 3 months.
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 |
|---|---|---|
| Innea, Innea AquaINNEA: one syringe contains 2.0 ml of non-pyrogenic gel. The gel is based on the following: sodium hyaluronate 20 mg/ml INNEA AQUA: one syringe contains 2.0 ml of non- pyrogenic gel. The gel is based on sodium hyaluronate 25 mg/ml, trehalose | Device | Innea |
Primary outcome
Lemperle Rating scale
Time frame: 1 month after the last injections
To evaluate the performance of INNEA and INNEA AQUA for the treatment of cheek and décolletage wrinkles after 1 month from the last injection, the lamperle Rating scale will be used: - The Lemperle Rating Scale (LRS) will be used to assess cheek wrinkles at V4 (1 month after the 3rd injection) by study product.
GAIS for improvement
Time frame: One month after the injections
The Global Aesthetic Improvement Scale (GAIS) scale will be used to assess improvement of décolletage wrinkles at V4 (1 month after the 3rd injection) by study product.
7 secondary outcomes
Outcome for performance with Lemperle Rating scale (LRS)
Time frame: 1 month after the last injections
Outcome safety: evaluation of adverse events
Time frame: 1 month after the last injections
Performance with Gais
Time frame: 1 month after the last injections
Performance with Likert scale
Time frame: 1 month after the last injections
Pain intensity evaluation with NRS scale
Time frame: 1 month after the last injections
Patience Satisfaction with Likert
Time frame: 1 month after the last injections
Evaluation of performance with Gais, secondary endpoint
Time frame: 1 month after the injections
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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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.
ASST degli Spedali Civili di Brescia
Brescia, Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innea, Innea Aqua in people with Wrinkle and Aging, run by Innate srl at 3 sites in Italy.
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 1 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: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lemperle Rating scale (time frame: 1 month after the last injections). 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 16 Apr 2026.