MedTrace Logo

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

NCT04614415 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-10-17

No results posted yet for this study

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

Interventions

DEVICE

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

OTHER

placebo

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

Sponsors & Collaborators

  • Fidia Farmaceutici s.p.a.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614415 on ClinicalTrials.gov