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

NCT ID: NCT04614415

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2024-12-31

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.

Conditions

Hypertrophic Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment group

group 1 will be treated with autocrosslinked Hyaluronic acid

Group Type: EXPERIMENTAL

Autocrosslinked Hyaluronic aid

Intervention Type: 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

control group

group 2 treated with placebo (isotonic saline solution).

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

The placebo consists in an isotonic saline solution (NaCl 0.9%)

Interventions

Autocrosslinked Hyaluronic aid

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: DEVICE

placebo

The placebo consists in an isotonic saline solution (NaCl 0.9%)

Intervention Type: OTHER

Other Intervention Names

IAL SYSTEM ACP

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fidia Farmaceutici s.p.a.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AOU Ospedali Riuniti- SOD Chirurgia ricostruttiva e chirurgia della mano

Ancona, , Italy

Site Status: RECRUITING

U.O. Centro Grandi Ustionati Ospedale Bufalini di Cesena - AUSL

Cesena, , Italy

Site Status: RECRUITING

U.O.C. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliero-Universitaria di Parma

Parma, , Italy

Site Status: NOT_YET_RECRUITING

U.O.C. Centro Ustioni Azienda Ospedaliero-Universitaria Pisana

Pisa, , Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Nicola Giordan

Role: CONTACT

ngiordan@fidiapharma.it

+39 349 823 2111

Facility Contacts

Michele Riccio, MD

Role: primary

Davide Melandri, Dr

Role: primary

Edoardo Caleffi, Prof.

Role: primary

Antonio Di Lonardo, Dr

Role: primary

Other Identifiers

LQ5I-19-01

Identifier Type: -

Identifier Source: org_study_id