Scar Gel Product Family Clinical Investigation

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hypertrophic Scars Cicatrix Cicatrix, Hypertrophic Collagen Diseases Connective Tissue Diseases Fibrosis Keloid Keloids Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dermatix

Device

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).

Dermatix Ultra

Device

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).

Primary outcomes

Vancouver Scar Scale (VSS)

Time frame: 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 outcomes

Satisfaction, Change from Baseline, Complications

Time frame: 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:
- unsatisfactory
- moderate
- good
- very good
- 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).

Sponsors and collaborators

Lead sponsor

Hanson Medical, Inc.

Industry

Registry information

Official study title

PMCF Investigation to Compare the Clinical Performance/Benefit of Dermatix With Dermatix Ultra

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 6, 2026
Registry last updated: Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed