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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04614415
Study type Interventional
Source Fidia Farmaceutici s.p.a.
Contact Nicola Giordan
Phone +39 349 823 2111
Email ngiordan@fidiapharma.it
Status Recruiting
Phase N/A
Start date January 14, 2020
Completion date December 31, 2024

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