An interventional study of Innea, Innea Aqua in Wrinkle and Aging, sponsored by Innate srl. Recruiting at 3 sites in Italy. Open to female participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Innate srl · Not applicable, Interventional, and Other
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
Investigational product:
INNEA and INNEA AQUA are CE-marked medical devices indicated for intradermal injections. In particular:
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:
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):
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).
Innate srl is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Innea, Innea Aqua
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
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.
Time frame: 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.
Time frame: One month after the injections
Outcome for performance with Lemperle Rating scale (LRS)
1\. 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 1 month after the injections
Device deficiency
Device deficiency/incidents will be monitored at V0, V1, V2.
Time frame: 1 month after the last injections
Evaluation during the duration of the study with diary
Concomitant medications and AEs will be monitored during the entire duration of the study through a diary dispensed to patients at V0.
Time frame: 1 month after the last injections
Ran from Jun 2023 to primary completion in Nov 2024, 17 months.
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