Hypertrophic Scars, Keloids
Conditions
Brief summary
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.
Interventions
DEVICEDermatix
Patients will be supplied with two 15g tubes of Dermatix at Visit 1 - Baseline Visit with the clinician, which will be sufficient to last the duration of the study (6-months) when applied as instructed (i.e. twice daily). If for any reason the patient runs out of the investigational product, a contingency supply will be in place and patients will be supplied with an additional tube. Patients will also be provided with the IFU of the supplied device and the clinician will provide instructions as to the application, frequency, and duration of use of the device (i.e. applied topically to the scar, twice daily for 6 months/until final study visit).
DEVICEDermatix Ultra
Patients will be supplied with two 15g tubes of Dermatix Ultra at Visit 1 - Baseline Visit with the clinician, which will be sufficient to last the duration of the study (6-months) when applied as instructed (i.e. twice daily). If for any reason the patient runs out of the investigational product, a contingency supply will be in place and patients will be supplied with an additional tube. Patients will also be provided with the IFU of the supplied device and the clinician will provide instructions as to the application, frequency, and duration of use of the device (i.e. applied topically to the scar, twice daily for 6 months/until final study visit).
Sponsors
Hanson Medical, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vancouver Scar Scale (VSS) | 6 months of treatment | Comparison of clinical symptoms and scar appearance between Dermatix and Dermatix Ultra (between the two study arms) using the Vancouver Scar Scale (VSS), i.e., * scar pigmentation * scar vascularity * scar pliability/elasticity * scar height * scar itchiness * scar pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction, Change from Baseline, Complications | 6 months of treatment | * Comparison of treatment satisfaction between Dermatix and Dermatix Ultra (between arms) after using a 5-point Likert scale to rate the treatment satisfaction as: 1. unsatisfactory 2. moderate 3. good 4. very good 5. excellent * Change from baseline (within arms) of clinical symptoms and scar appearance using the VSS, i.e., * scar pigmentation * scar vascularity * scar pliability/elasticity * scar height * scar itchiness * scar pain * The incidence of all complications during the study period, including: * Adverse Events (AE) * Serious Adverse Events (SAEs), * Serious Adverse Device Effects (SADE), * Unanticipated Serious Adverse Device Effect (USADE). |
Outcome results
None listed