Evaluating Hyaluronic Acid for Treating Hypertrophic Scars
Multicenter, Double Blind, Randomized, Controlled Clinical Investigation to Evaluate the Performance of Autocross-linked Hyaluronic Acid for the Treatment of Hypertrophic Scars
This study is testing if a new type of hyaluronic acid injection can help improve hypertrophic scars compared to a placebo treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fidia Farmaceutici s.p.a. Industry-sponsored |
| Locations | 4 sites (Ancona and 3 other locations) |
| Trial ID | NCT04614415 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the effectiveness of auto-cross-linked Hyaluronic acid in treating hypertrophic scars through intralesional and hypodermic injections. Patients will be randomized into two groups, with one receiving the treatment and the other receiving a placebo of isotonic saline solution. Evaluations will be conducted using the POSAS scale and ultrasound assessments at multiple time points post-treatment. Additionally, a small surgical biopsy may be performed for histological evaluation of the scar tissue before and after treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with hypertrophic scars caused by trauma, burns, or iatrogenic injuries that have been present for at least 12 months.
Not a fit: Patients with type I and type II diabetes mellitus or those with oncological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the appearance and quality of life for patients with hypertrophic scars.
How similar studies have performed: Other studies have shown promise in using Hyaluronic acid for scar treatment, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ancona and 3 other locations
- AOU Ospedali Riuniti- SOD Chirurgia ricostruttiva e chirurgia della mano — Ancona, Italy (Recruiting)
- U.O. Centro Grandi Ustionati Ospedale Bufalini di Cesena - AUSL — Cesena, Italy (Recruiting)
- U.O.C. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliero-Universitaria di Parma — Parma, Italy (Not_yet_recruiting)
- U.O.C. Centro Ustioni Azienda Ospedaliero-Universitaria Pisana — Pisa, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Nicola Giordan
- Email: ngiordan@fidiapharma.it
- Phone: +39 349 823 2111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.