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Clinical Investigation to Evaluate the Performance of Hyaluronic Acid for the Treatment of Hypertrophic Scars

Primary Purpose

Hypertrophic Scar

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Autocrosslinked Hyaluronic aid
placebo
Sponsored by
Fidia Farmaceutici s.p.a.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Scar

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

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
  • 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

Sites / Locations

  • AOU Ospedali Riuniti- SOD Chirurgia ricostruttiva e chirurgia della manoRecruiting
  • U.O. Centro Grandi Ustionati Ospedale Bufalini di Cesena - AUSLRecruiting
  • U.O.C. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliero-Universitaria di Parma
  • U.O.C. Centro Ustioni Azienda Ospedaliero-Universitaria Pisana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

control group

Arm Description

group 1 will be treated with autocrosslinked Hyaluronic acid

group 2 treated with placebo (isotonic saline solution).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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)
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
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.

Full Information

First Posted
March 2, 2020
Last Updated
October 16, 2023
Sponsor
Fidia Farmaceutici s.p.a.
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1. Study Identification

Unique Protocol Identification Number
NCT04614415
Brief Title
Clinical Investigation to Evaluate the Performance of Hyaluronic Acid for the Treatment of Hypertrophic Scars
Official Title
Multicenter, Double Blind, Randomized, Controlled Clinical Investigation to Evaluate the Performance of Autocross-linked Hyaluronic Acid for the Treatment of Hypertrophic Scars
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fidia Farmaceutici s.p.a.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
group 1 will be treated with autocrosslinked Hyaluronic acid
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
group 2 treated with placebo (isotonic saline solution).
Intervention Type
Device
Intervention Name(s)
Autocrosslinked Hyaluronic aid
Other Intervention Name(s)
IAL SYSTEM ACP
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
The placebo consists in an isotonic saline solution (NaCl 0.9%)
Primary Outcome Measure Information:
Title
Change from baseline to Day 90 in POSAS total score for Observer
Description
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.
Time Frame
90 days after treatment
Secondary Outcome Measure Information:
Title
To evaluate the performance of IAL-SYSTEM ACP in improving the quality of the scar
Description
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
Time Frame
after 30 and 180 days from the first treatment
Title
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)
Description
Change from baseline to post-baseline visits (T30, T90 and T180) in DLQI score (dermatology quality of life Index)
Time Frame
after 30, 90 and 180 days from the first treatment
Title
To assess the changing in the dermal volume after 30, 90 and 180 days from the first treatment
Description
Change from baseline to post-baseline visits (T30, T90 and T180) in dermal volume measured by ultrasound
Time Frame
after 30, 90 and 180 days
Title
Safety of the treatment. Number of patients with treatment related adverse events
Description
Safety evaluation examining the local and systemic adverse effects as consequence of the treatment and any other adverse event occurred during the study.
Time Frame
throug clinical investigation completion, an average one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Giordan
Phone
+39 349 823 2111
Email
ngiordan@fidiapharma.it
Facility Information:
Facility Name
AOU Ospedali Riuniti- SOD Chirurgia ricostruttiva e chirurgia della mano
City
Ancona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Riccio, MD
Facility Name
U.O. Centro Grandi Ustionati Ospedale Bufalini di Cesena - AUSL
City
Cesena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davide Melandri, Dr
Facility Name
U.O.C. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliero-Universitaria di Parma
City
Parma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edoardo Caleffi, Prof.
Facility Name
U.O.C. Centro Ustioni Azienda Ospedaliero-Universitaria Pisana
City
Pisa
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Di Lonardo, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Investigation to Evaluate the Performance of Hyaluronic Acid for the Treatment of Hypertrophic Scars

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