Scar Gel Product Family Clinical Investigation

ConditionsHypertrophic Scars Keloids

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

This trial does not accept healthy volunteers

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 population

The total number of subjects will be 75 per arm (150 total). However, to allow for potential dropouts and protocol deviations, the planned enrolment will be increased by approximately 10%, yielding a total of 84 per arm (168 total). To ensure that both treatment groups include patients with (a) scars at risk of developing hypertrophic or keloid scars (i.e., recent scars) and (b) pre-existing hypertrophic or keloid scars (i.e., older scars), a stratified randomization procedure will be used. This approach will evenly distribute the proportion of older scars and recent scars between the two groups based on the estimated prevalence of pathological scars in the overall scar population.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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).

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Recent Scar2 interventions

Group B: Older Scars2 interventions

Trial outcomes

Primary outcomes

Vancouver Scar Scale (VSS)

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

Time frame

6 months of treatment

Secondary outcomes

Satisfaction, Change from Baseline, Complications

* 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).

Time frame

6 months of treatment

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hanson Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov

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