Clinical trial NCT04614415: 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
Overall status: RECRUITING
Phase: NA
Conditions: Hypertrophic Scar
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline to Day 90 in POSAS total score for Observer
timeFrame: 90 days after treatment
Secondary outcomes:
measure: To evaluate the performance of IAL-SYSTEM ACP in improving the quality of the scar
timeFrame: after 30 and 180 days from the first treatment
measure: 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)
timeFrame: after 30, 90 and 180 days from the first treatment
measure: To assess the changing in the dermal volume after 30, 90 and 180 days from the first treatment
timeFrame: after 30, 90 and 180 days
measure: Safety of the treatment. Number of patients with treatment related adverse events
timeFrame: throug clinical investigation completion, an average one year
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti- SOD Chirurgia ricostruttiva e chirurgia della mano
city: Cesena
country: Italy
facility: U.O. Centro Grandi Ustionati Ospedale Bufalini di Cesena - AUSL
city: Parma
country: Italy
facility: U.O.C. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliero-Universitaria di Parma
city: Pisa
country: Italy
facility: U.O.C. Centro Ustioni Azienda Ospedaliero-Universitaria Pisana
Study officials:
References: