Scar Gel Product Family Clinical Investigation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
SponsorHanson Medical, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Dermatix
- Dermatix Ultra
Treatment groups
150 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov