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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | group 1 will be treated with autocrosslinked Hyaluronic acid |
|
| control group | Placebo Comparator | group 2 treated with placebo (isotonic saline solution). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autocrosslinked Hyaluronic aid | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | after 30 and 180 days from the first treatment |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with type I and type II diabetes mellitus
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola Giordan | Contact | +39 349 823 2111 | ngiordan@fidiapharma.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Ospedali Riuniti- SOD Chirurgia ricostruttiva e chirurgia della mano | Recruiting | Ancona | Italy |
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| placebo | Other | The placebo consists in an isotonic saline solution (NaCl 0.9%) |
|
| 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) |
| 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 | 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. | throug clinical investigation completion, an average one year |
| U.O. Centro Grandi Ustionati Ospedale Bufalini di Cesena - AUSL | Recruiting | Cesena | Italy |
|
| U.O.C. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliero-Universitaria di Parma | Not yet recruiting | Parma | Italy |
|
| U.O.C. Centro Ustioni Azienda Ospedaliero-Universitaria Pisana | Not yet recruiting | Pisa | Italy |
|