Scar Gel Product Family Clinical Investigation

Starting soon

Conditions studied: Hypertrophic Scars, Keloids

In brief

The purpose of this PMCF investigation is to determine whether there are differences between the two formulations (Dermatix and Dermatix Ultra) in improving keloid and hypertrophic scars clinical symptoms and in the overall scar perception (including scar appearance and treatment perception). This PMCF investigation has been designed to address the conclusions of the latest CER \[PDPROJ-4-CE-R\] and the objectives. It has been chosen as an appropriate activity as it enables the collection of device-specific data on both device formulations and on the entire intended population. Moreover, the design of the PMCF investigation (single-center, parallel, open-label, two-arm, randomized controlled study) enables the direct comparison of the clinical performance/benefit between the two formulations.

Key facts

Study ID

NCT07684573

Run by

Hanson Medical, Inc.

People needed

150

Starts

2026-07-01

Expected to finish

2026-12-01

Last updated by the study team

2026-07-06

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged >3 years.
• Patients with keloids and hypertrophic scars (such as those resulting from general surgical procedures, trauma wounds, and burns), i.e., older scars.
• Patients at risk of developing keloids and hypertrophic scars, i.e., recent scars.

You may not qualify if…

• Patients with unhealed and/or open wounds.
• Patients with allergies to any of the ingredients.
• Pregnant or breastfeeding women.
• Patients using other topical skin treatments on/around the scar area.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.