Skin AgingNCT06719154
Evaluation of the Safety and Efficacy of Profhilo® Structura
An observational study of Skin Aging, run by IBSA Farmaceutici Italia Srl at 3 sites in 2 countries.
Trial summary
Profhilo® Structura is composed of a buffered saline solution of high molecular weight (H-HA) and low molecular weight (L-HA) hyaluronic acid. The high- and low-molecular-weight HA used in the device is obtained by biofermentation and has not undergone chemical modification processes; this results in excellent… Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Profhilo Structura
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Sep 2024to Dec 2025
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult of both sexes seeking for a corrective/filling action of natural and induced skin depressions.
Who may be able to join
- Healthy subjects
- Male and Female subjects.
- Age : between 35 and 55 year
- Subject having given freely and expressly his/her informed consent obtained according to ISO 14155:2020 and Good Clinical Practice (GCP)
- Only for treated group: Subject seeking aesthetic improvement for a corrective/filling action of natural and induced skin depressions
- Women of childbearing potential must have a negative urine pregnancy test result at inclusion visit and must use a reliable method of contraception since at least 12 weeks and throughout the study.
Show all 10Show fewer
- Subject psychologically able to understand the information related to the investigation including possible risks and side effects.
- Subject able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on investigator's judgement.
- Subject agreeing to keep their usual cleansing / care products during the whole study period.
- Subject agreeing to apply a SPF50 cream during the whole study period.
Who cannot join
- In terms of population
- Pregnant or breastfeeding woman or planning a pregnancy during the study.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
- Subject enrolled in another study or whose non-enrollment period is not over.
- For France only: subject having received a total of 6.000 euros as compensations for their participation in the present study.
Show all 40Show fewer
- Subject disagrees to keep a stable weight during the study (BMI variation ± 1)
- Subject with high expectations for the treatment effect.
- In terms of associated pathology
- Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety
- Subject with known history of or suffering from autoimmune disease and/or immune deficiency
- Subject suffering from active disease such as inflammation, infection, tumour, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea, porphyria…) in the 6 months before screening visit
- Subject with a history of streptococcal disease or an active streptococcus infection
- Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
- Subject predisposed to keloids or hypertrophic scarring or having healing disorders
- Subject having history of severe allergy or anaphylactic shock including known risk of hypersensitivity to one of the components of the composition of the investigational device and to antiseptic solution related to previous or current treatment.
- Subjects with scar, mole, hair or local skin infection (including viral, bacterial, and fungal); skin granulomas; scar constitution; immune system disorders; presence of active or progressive skin disorders or skin diseases with isomorphic response in the treatment area, such as acute eczema, flat wart, lichen planus, psoriasis vulgaris, etc…
- Patients with psychiatric disorders or emotional instability.
- In terms of previous or ongoing treatment or procedure
- Any medication which may interfere, at the interpretation of the investigator, with the study objectives.
- Subject having undergone tooth extraction or dental implant procedure within the past 6 weeks or plans to undergo these procedures during the study.
- Subject having received facial or cervico-facial lifting in the past 24 months or plans to undergo these procedures during the study.
- Subject having received treatment with a laser, ultrasound or radiofrequency treatment, a dermabrasion, a surgery, a chemical peeling or any other procedure based on active dermal response on the face within the past 6 months or who plans to undergo any of these procedures during the study.
- Subject having received within the past 18 months or planning to receive during the study any injections outside of those in the study protocol including non-permanent fillers (e.g., HA, Calcium Hydroxyapatite) or autologous fat on or near the face.
- Subject having received within the past 9 months or planning to receive during the study any injections outside of those in the study protocol including mesotherapy or botulinum neurotoxin on or near the face.
- Subject having received at any time or planning to receive a permanent filler on the face (e.g., polylactic acid, Polymethylmethacrylate, silicone) during the study.
- Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand).
- Subject having received in the last 24 months resorbable threads lift on the face.
- Subject having received at any time injection with unknown products
- Subject using medication such as aspirin, high dose Vitamin C, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit or being a chronic user.
- Subject using medication such as narcotic, and immunosuppressive drugs from three weeks before screening visit and during the whole study period
- Subject having started or stopped an antidepressant 3 weeks prior the study or plans to use it during the study.
- Subject undergoing a topical treatment on the face or a systemic treatment:
- anti-inflammatory medication and/or antihistamines within the past 2 weeks and during the study,
- corticosteroids within the past 2 weeks and during the study,
- retinoids and/or immunosuppressors within the past 3 months and during the study.
- In terms of lifestyle
- Intensive exposure to sunlight or UV-rays within the previous month and/or planning to do so during the study.
- Heavy smoker (subject who reports smoking 10 or more cigarettes per day);
- Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day)
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Poland2 sites, 2 recruiting
- Not yet recruiting
Eurofins Dermscan Poland
Gdansk, 80-288
Camille Chambost, +33(0)4 72 89 36 56, camille.chambost@cpt.eurofinseu.com
- Not yet recruiting
Aesthetic clinical
Poznan, 80-288
France1 site, 1 recruiting
- Recruiting
Eurofins Dermscan Pharmascan
Villeurbanne, Lyon, 69100
Camille Chambost, +33(0)4 72 89 36 56, camille.chambost@cpt.eurofinseu.com
About this study
Official title: Prospective, Multicentric, Controlled, Double Arm Clinical Investigation to Evaluate the Safety and Efficacy of Profhilo® Structura for Face Adipose Tissue Restoration
Profhilo® Structura is composed of a buffered saline solution of high molecular weight (H-HA) and low molecular weight (L-HA) hyaluronic acid. The high- and low-molecular-weight HA used in the device is obtained by biofermentation and has not undergone chemical modification processes; this results in excellent tolerability of the product.
In addition, the HA chains with different molecular weight present in Profhilo® Structura, thanks to a specific and patented treatment of the solution (NAHYCO® Hybrid Technology), interact with each other, giving Profhilo® Structura unique rheological properties that allow higher concentrations of HA to be administered at equal viscosity of the solution.
Read more
The formulation based on HA with different molecular weight contained in Profhilo® Structura is based on the Hydrolift® Action system, the innovative approach aimed at combating the physiological decrease of HA in the skin, restoring hydration, elasticity and tone, synergistically associating deep hydration with the mechanical lifting action of the skin depression.
Thanks to its rheological properties and cohesivity Profhilo® Structura is able to optimally spread and integrate into the interstitial spaces of the adipose tissue. Profhilo® Structura has the specific indication for adipose tissue restoration and is able to counteract facial volume loss.
Read the detailed description
Profhilo® Structura (HILOW 4.5% hyaluronic acid [HA] sodium salt for intradermal use; developed by IBSA Farmaceutici Italia Srl) is the first Conformité Européenne (CE)-certified HA-based injectable, sterilized, apyrogenic, and resorbable product indicated for female or male adults with mild-to-moderate volume loss in the face or neck to restore adipose tissue, correct and fill natural and induced cutaneous depressions, and improve skin laxity. Profhilo® Structura is also indicated for dermal tissue repair in adults with acne scars.
Profhilo® Structura contains a combination of high and low molecular weight HA chains that interact with each other for unique rheological characteristics that enable the administration of higher concentrations of HA, without an increase in viscosity.
Profhilo® Structura has a corrective/filling action on natural and induced skin depressions formed because of reduced endogenous HA levels and skin hydration, alteration of elastic fibers and collagen in the dermis, and loss of turgor and skin tone (all characteristics which can occur following excessive dehydration, weight loss, or aging). Administered subcutaneously by qualified personnel, the viscoelastic and moisturizing properties of the HA in Profhilo® Structura and the ability to maintain HA to adequate levels within skin tissues using this medical device, enables tissue rehydration, creates optimal conditions for tissue remodeling, and intervenes with the physiological process of skin ageing.
The administration of Profhilo® Structura allows the tissue restoration using the physiological amount of HA. Furthermore, HCC of high and low molecular weight HA combines the regenerating trophic effect of low molecular weight HA on the epidermis (a HYDRO effect), and the plastic modelling effect of high molecular weight HA on the dermis (a LIFT effect, also known as Hydrolift® Action).
Because of its rheological properties and cohesivity, Profhilo® Structura is able to optimally spread and integrate into the interstitial spaces of the adipose tissue. Profhilo® Structura is specifically indicated for adipose tissue restoration and is able to counteract facial volume loss.
- Conditions
- Skin Aging
- Being tested
- Profhilo Structura, Sham (No Treatment)
- Keywords
- aging, adipose tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Profhilo StructuraDevice
2 injections (30 days apart) of investigated medical device into superficial fat compartments of zygomatic arch and preauricular area
Sham (No Treatment)Other
Sham (No Treatment)
| Study group | Role | What they receive |
|---|---|---|
| Treated group | 120 subjects will be treated
Healthy subjects Male and Female subjects. Age : between 35 and 55 year Receives: Device: Profhilo Structura | |
| Not treated group | 44 subjects will be not treated
Healthy subjects Male and Female subjects. Age : between 35 and 55 year Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint
Number and percentage of subjects with Adverse Device Effects (ADEs) throughout the study.
Measured: Day 0, Day 30, Day 60, Day 120, Day 180
Secondary outcomes (5)
Safety endpoint - ISR
Number and percentage of subjects with Injection Site Reaction (ISR) and Adverse Events (AEs).
Measured: Day 0, Day 30, Day 60, Day 120, Day 180
Efficacy endpoint - clinical improvement
Percentage of subjects with a clinical improvement from baseline assessed by investigator compared to control group.
Measured: Day 0, Day 30, Day 60, Day 120, Day 180
Efficacy endpoint - skin quality
Percentage of subjects with a skin quality improvement using Beagley-Gibson surface microrelief scale (from grade 1 [Mild] to grade 4 [Severe] from baseline as assessed by investigator compared to control group.
Measured: Day 0, Day 30, Day 60, Day 120, Day 180
Efficacy endpoint - satisfaction
Percentage of positive responders (rated 3 or less) on the GAIS (from grade 1 [Very much improved] to grade 5 [Worse] as assessed by investigator and subjects in live.
Measured: Day 0, Day 30, Day 60, Day 120, Day 180
Efficacy endpoint - instrumental improvement
Percentage of subjects with a instrumental improvement from baseline assessed by investigator compared to control group.
Measured: Day 0, Day 30, Day 60, Day 120, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start9 Sep 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IBSA Farmaceutici Italia Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan, IBSA Institut Biochimique SA
- Responsible party
- Sponsor
- Investigators
- Izabela Błażewicz, MD, Principal investigator, Eurofins Dermscan Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719154
- Sponsor's protocol ID
- 23E3318
- Status last verified
- Nov 2024
- First submitted
- 17 Apr 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Controlled, Double Arm Clinical Investigation to Evaluate the Safety and Efficacy of Profhilo® Structura for Face Adipose Tissue Restoration
- ClinicalTrials.gov ID
- NCT06719154
- Acronym / sponsor ID
- 23E3318
- Conditions
- Skin Aging
- Keywords
- aging, adipose tissue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- IBSA Farmaceutici Italia SrlIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan, IBSA Institut Biochimique SA
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Dec 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.
Profhilo® Structura is composed of a buffered saline solution of high molecular weight (H-HA) and low molecular weight (L-HA) hyaluronic acid. The high- and low-molecular-weight HA used in the device is obtained by biofermentation and has not undergone chemical modification processes; this results in excellent tolerability of the product.
In addition, the HA chains with different molecular weight present in Profhilo® Structura, thanks to a specific and patented treatment of the solution (NAHYCO® Hybrid Technology), interact with each other, giving Profhilo® Structura unique rheological properties that allow higher concentrations of HA to be administered at equal viscosity of the solution.
The formulation based on HA with different molecular weight contained in Profhilo® Structura is based on the Hydrolift® Action system, the innovative approach aimed at combating the physiological decrease of HA in the skin, restoring hydration, elasticity and tone, synergistically associating deep hydration with the mechanical lifting action of the skin depression.
Thanks to its rheological properties and cohesivity Profhilo® Structura is able to optimally spread and integrate into the interstitial spaces of the adipose tissue. Profhilo® Structura has the specific indication for adipose tissue restoration and is able to counteract facial volume loss.
Detailed description
Profhilo® Structura (HILOW 4.5% hyaluronic acid [HA] sodium salt for intradermal use; developed by IBSA Farmaceutici Italia Srl) is the first Conformité Européenne (CE)-certified HA-based injectable, sterilized, apyrogenic, and resorbable product indicated for female or male adults with mild-to-moderate volume loss in the face or neck to restore adipose tissue, correct and fill natural and induced cutaneous depressions, and improve skin laxity. Profhilo® Structura is also indicated for dermal tissue repair in adults with acne scars.
Profhilo® Structura contains a combination of high and low molecular weight HA chains that interact with each other for unique rheological characteristics that enable the administration of higher concentrations of HA, without an increase in viscosity.
Profhilo® Structura has a corrective/filling action on natural and induced skin depressions formed because of reduced endogenous HA levels and skin hydration, alteration of elastic fibers and collagen in the dermis, and loss of turgor and skin tone (all characteristics which can occur following excessive dehydration, weight loss, or aging). Administered subcutaneously by qualified personnel, the viscoelastic and moisturizing properties of the HA in Profhilo® Structura and the ability to maintain HA to adequate levels within skin tissues using this medical device, enables tissue rehydration, creates optimal conditions for tissue remodeling, and intervenes with the physiological process of skin ageing.
The administration of Profhilo® Structura allows the tissue restoration using the physiological amount of HA. Furthermore, HCC of high and low molecular weight HA combines the regenerating trophic effect of low molecular weight HA on the epidermis (a HYDRO effect), and the plastic modelling effect of high molecular weight HA on the dermis (a LIFT effect, also known as Hydrolift® Action).
Because of its rheological properties and cohesivity, Profhilo® Structura is able to optimally spread and integrate into the interstitial spaces of the adipose tissue. Profhilo® Structura is specifically indicated for adipose tissue restoration and is able to counteract facial volume loss.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group | – | Device: Profhilo Structura120 subjects will be treated Healthy subjects Male and Female subjects. Age : between 35 and 55 year |
| Not treated group | – | Other: Sham (No Treatment)44 subjects will be not treated Healthy subjects Male and Female subjects. Age : between 35 and 55 year |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult of both sexes seeking for a corrective/filling action of natural and induced skin depressions.
Key inclusion criteria (10 listed)
- Healthy subjects
- Male and Female subjects.
- Age : between 35 and 55 year
- Subject having given freely and expressly his/her informed consent obtained according to ISO 14155:2020 and Good Clinical Practice (GCP)
- Only for treated group: Subject seeking aesthetic improvement for a corrective/filling action of natural and induced skin depressions
Key exclusion criteria (40 listed)
- In terms of population
- Pregnant or breastfeeding woman or planning a pregnancy during the study.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
- Subject enrolled in another study or whose non-enrollment period is not over.
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 |
|---|---|---|
| Profhilo Structura2 injections (30 days apart) of investigated medical device into superficial fat compartments of zygomatic arch and preauricular area | Device | Treated group |
| Sham (No Treatment)Sham (No Treatment) | Other | Not treated group |
Primary outcome
Safety endpoint
Time frame: Day 0, Day 30, Day 60, Day 120, Day 180
Number and percentage of subjects with Adverse Device Effects (ADEs) throughout the study.
5 secondary outcomes
Safety endpoint - ISR
Time frame: Day 0, Day 30, Day 60, Day 120, Day 180
Efficacy endpoint - clinical improvement
Time frame: Day 0, Day 30, Day 60, Day 120, Day 180
Efficacy endpoint - skin quality
Time frame: Day 0, Day 30, Day 60, Day 120, Day 180
Efficacy endpoint - satisfaction
Time frame: Day 0, Day 30, Day 60, Day 120, Day 180
Efficacy endpoint - instrumental improvement
Time frame: Day 0, Day 30, Day 60, Day 120, Day 180
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 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Skin Aging
RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Active, not recruiting
Integrated Actionable Aging Assessment for Cancer Patients Pilot
Breast Cancer, Hodgkin Lymphoma
Not yet recruitingObservational study
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
Periorbital Hollowing, Skin Aging
Not yet recruitingObservational study
Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)
Skin Aging, Horizontal Neck Lines
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging
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.
Izabela Błażewicz, MD principal investigator
Eurofins Dermscan Poland
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Aging, run by IBSA Farmaceutici Italia Srl at 3 sites in 2 countries.
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 10 inclusion and 40 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 5 Dec 2024. 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 Poland, France. 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?
Contact Gilberto Bellia (+39 71617360, g.bellia@ibsa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoint (time frame: Day 0, Day 30, Day 60, Day 120, Day 180). 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 5 Dec 2024.