Hypertrophic ScarNCT04614415
Clinical Investigation to Evaluate the Performance of Hyaluronic Acid for the Treatment of Hypertrophic Scars
A study testing Autocrosslinked Hyaluronic aid in people with Hypertrophic Scar, run by Fidia Farmaceutici s.p.a. at 4 sites in Italy.
Trial summary
The study includes two study groups, one involves treatment with auto-cross-linked Hyaluronic acid by intralesional and hypodermic injection, repeated after two weeks (T14), while the control arm provides an equal treatment but with isotonic saline solution. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertrophic Scar
- What is being tested?
- Autocrosslinked Hyaluronic aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 4 sitesItaly
- Study dates
- 14 Jan 2020to 31 Dec 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Male or female subjects aged ≥ 18 and ≤ 85 years
- Subjects with hypertrophic scars caused by trauma, burn or iatrogenic injury with or without involvement of the mobile joints
- Scar > 2 to < 25 cm2 of surface
- Scar not previously treated with corticosteroids, laser or other invasive treatments
- Scar present for at least 12 months
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- Scar located in all areas of the body with the exception of the face and neck
- Fitzpatrick skin score of I-VI
- Subjects willing to comply with all the steps of treatment and follow-up visits
- Subjects willing to refrain from any cosmetic intervention in the area to be treated during the clinical investigation
- Female of child-bearing potential (i.e. not in menopausal status from at least one year or permanently sterilized) must have a negative urine pregnancy test prior the first treatment
Who cannot join
- Subjects with type I and type II diabetes mellitus
- Subjects with oncological diseases in progress or in remission
- Subjects receiving immunosuppressive drugs and corticosteroids, anticoagulants, antiplatelet agents
- Subjects with autoimmune diseases including connectivitis
- Subjects with congenital or acquired immunodeficiencies (including metabolic ones)
- Subjects with known allergy or hypersensitivity to hyaluronic acid or its derivatives
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- Participation in clinical trials/investigations in the last 30 days
- Pregnant or breastfeeding women
- If female and of child-bearing potential, subject not using a highly effective method of birth control and not willing to use it during the participation to the clinical investigation
- Subjects not willing to avoid tanning during the clinical investigation
- Subjects with inflammations of the skin, including rosacea
- Subject with skin infection in the area to be treated
- Subjects having a high probability of non-compliance with the study procedures according to Investigator's judgement
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
AOU Ospedali Riuniti- SOD Chirurgia ricostruttiva e chirurgia della mano
Ancona
Michele Riccio, MD
- Recruiting
U.O. Centro Grandi Ustionati Ospedale Bufalini di Cesena - AUSL
Cesena
Davide Melandri, Dr
- Not yet recruiting
U.O.C. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliero-Universitaria di Parma
Parma
Edoardo Caleffi, Prof.
- Not yet recruiting
U.O.C. Centro Ustioni Azienda Ospedaliero-Universitaria Pisana
Pisa
Antonio Di Lonardo, Dr
About this study
Official title: Multicenter, Double Blind, Randomized, Controlled Clinical Investigation to Evaluate the Performance of Autocross-linked Hyaluronic Acid for the Treatment of Hypertrophic Scars
The study includes two study groups, one involves treatment with auto-cross-linked Hyaluronic acid by intralesional and hypodermic injection, repeated after two weeks (T14), while the control arm provides an equal treatment but with isotonic saline solution.
Enrolled patients will be randomized into 2 groups with an allocation of 2:1 in study treatment arm and control arm respectively. They will be evaluated using the POSAS scale before the treatment and re-evaluated at 30, 90 and 180 days after treatment.
Read more
The scar evaluation will be completed by an ultrasound assessment at time 0 (T0), 30 (T30), T90 and T180 and the DLQI (Dermatology Life Quality Index) to be assessed at time 0 (T0), 30 (T30), 90 (T90) and 180 (T180).
In subjects that will consent, a small surgical biopsy for an explorative evaluation of the scar tissue will be performed before (T0) and after treatment (T30) for a histological assessment.
- Conditions
- Hypertrophic Scar
- Being tested
- Autocrosslinked Hyaluronic aid, placebo
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autocrosslinked Hyaluronic aidDevice
Also called IAL SYSTEM ACP
IAL-SYSTEM ACP gel is an auto-cross-linked HA derivative in the form of highly viscous gel. In this direct formation of ester linkages no foreign substances are introduced into the molecule, thus catabolism of ACP leads only to HA
placeboOther
The placebo consists in an isotonic saline solution (NaCl 0.9%)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | group 1 will be treated with autocrosslinked Hyaluronic acid Receives: Device: Autocrosslinked Hyaluronic aid |
| control group | Placebo comparator | group 2 treated with placebo (isotonic saline solution). Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Day 90 in POSAS total score for Observer
The performance of two injections of IAL-SYSTEM ACP in improving the quality of the scar after 90 days from the first treatment in patients with hypertrophic scars will be evaluated by the mean change from baseline to Day 90 in POSAS total score for Observer.
Measured: 90 days after treatment
Secondary outcomes (4)
To evaluate the performance of IAL-SYSTEM ACP in improving the quality of the scar
Change from baseline to post-baseline visits (T30, T90 and T180) in total POSAS scores (sum total of Patient and Observer scores), and POSAS total score for Patient and Observer
Measured: after 30 and 180 days from the first treatment
To assess the changing in the Quality of life after 30, 90 and 180 days from the first treatment with the Dermatology Life Quality Index (DLQI)
Change from baseline to post-baseline visits (T30, T90 and T180) in DLQI score (dermatology quality of life Index)
Measured: after 30, 90 and 180 days from the first treatment
To assess the changing in the dermal volume after 30, 90 and 180 days from the first treatment
Change from baseline to post-baseline visits (T30, T90 and T180) in dermal volume measured by ultrasound
Measured: after 30, 90 and 180 days
Safety of the treatment. Number of patients with treatment related adverse events
Safety evaluation examining the local and systemic adverse effects as consequence of the treatment and any other adverse event occurred during the study.
Measured: throug clinical investigation completion, an average one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start14 Jan 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614415
- Sponsor's protocol ID
- LQ5I-19-01
- Status last verified
- Oct 2023
- First submitted
- 2 Mar 2020
- Last updated
- 17 Oct 2023
- Results posted
- 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double Blind, Randomized, Controlled Clinical Investigation to Evaluate the Performance of Autocross-linked Hyaluronic Acid for the Treatment of Hypertrophic Scars
- ClinicalTrials.gov ID
- NCT04614415
- Acronym / sponsor ID
- LQ5I-19-01
- Conditions
- Hypertrophic Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Nov 2020 (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 study includes two study groups, one involves treatment with auto-cross-linked Hyaluronic acid by intralesional and hypodermic injection, repeated after two weeks (T14), while the control arm provides an equal treatment but with isotonic saline solution.
Enrolled patients will be randomized into 2 groups with an allocation of 2:1 in study treatment arm and control arm respectively. They will be evaluated using the POSAS scale before the treatment and re-evaluated at 30, 90 and 180 days after treatment.
The scar evaluation will be completed by an ultrasound assessment at time 0 (T0), 30 (T30), T90 and T180 and the DLQI (Dermatology Life Quality Index) to be assessed at time 0 (T0), 30 (T30), 90 (T90) and 180 (T180).
In subjects that will consent, a small surgical biopsy for an explorative evaluation of the scar tissue will be performed before (T0) and after treatment (T30) for a histological assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Autocrosslinked Hyaluronic aidgroup 1 will be treated with autocrosslinked Hyaluronic acid |
| control group | Placebo comparator | Other: placebogroup 2 treated with placebo (isotonic saline solution). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent
- Male or female subjects aged ≥ 18 and ≤ 85 years
- Subjects with hypertrophic scars caused by trauma, burn or iatrogenic injury with or without involvement of the mobile joints
- Scar > 2 to < 25 cm2 of surface
- Scar not previously treated with corticosteroids, laser or other invasive treatments
Key exclusion criteria (13 listed)
- Subjects with type I and type II diabetes mellitus
- Subjects with oncological diseases in progress or in remission
- Subjects receiving immunosuppressive drugs and corticosteroids, anticoagulants, antiplatelet agents
- Subjects with autoimmune diseases including connectivitis
- Subjects with congenital or acquired immunodeficiencies (including metabolic ones)
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 |
|---|---|---|
| Autocrosslinked Hyaluronic aidAlso: IAL SYSTEM ACPIAL-SYSTEM ACP gel is an auto-cross-linked HA derivative in the form of highly viscous gel. In this direct formation of ester linkages no foreign substances are introduced into the molecule, thus catabolism of ACP leads only to HA | Device | Treatment group |
| placeboThe placebo consists in an isotonic saline solution (NaCl 0.9%) | Other | control group |
Primary outcome
Change from baseline to Day 90 in POSAS total score for Observer
Time frame: 90 days after treatment
The performance of two injections of IAL-SYSTEM ACP in improving the quality of the scar after 90 days from the first treatment in patients with hypertrophic scars will be evaluated by the mean change from baseline to Day 90 in POSAS total score for Observer.
4 secondary outcomes
To evaluate the performance of IAL-SYSTEM ACP in improving the quality of the scar
Time frame: after 30 and 180 days from the first treatment
To assess the changing in the Quality of life after 30, 90 and 180 days from the first treatment with the Dermatology Life Quality Index (DLQI)
Time frame: after 30, 90 and 180 days from the first treatment
To assess the changing in the dermal volume after 30, 90 and 180 days from the first treatment
Time frame: after 30, 90 and 180 days
Safety of the treatment. Number of patients with treatment related adverse events
Time frame: throug clinical investigation completion, an average one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autocrosslinked Hyaluronic aid in people with Hypertrophic Scar, run by Fidia Farmaceutici s.p.a. at 4 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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Giordan (+39 349 823 2111, ngiordan@fidiapharma.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Day 90 in POSAS total score for Observer (time frame: 90 days after treatment). 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 17 Oct 2023.