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

Launched by FIDIA FARMACEUTICI S.P.A. · Oct 28, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of a treatment called hyaluronic acid for patients with hypertrophic scars, which are thick, raised scars that can form after injuries, burns, or surgeries. In this study, participants will be divided into two groups: one will receive hyaluronic acid injections directly into their scars, while the other group will receive a placebo treatment using a saline solution. The trial aims to see how well the treatments work over time, with evaluations taking place at several points after the treatment, including assessments of the scars and the patients' quality of life.

To be eligible for the study, participants must be between 18 and 85 years old and have hypertrophic scars that are at least 12 months old and not previously treated with invasive methods. They should also be willing to attend follow-up visits and refrain from any cosmetic treatments in the scar area during the study. It's important to note that individuals with certain medical conditions, such as diabetes or ongoing cancer treatment, as well as pregnant or breastfeeding women, will not be included in the trial. Participants can expect to undergo a small biopsy for further analysis before and after the treatment, along with regular assessments of their scars over the course of the study.

Gender

ALL

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