Scar Gel Product Family Clinical Investigation

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 3 years and older
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study 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.

About this study

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

Conditions

Hypertrophic Scars, Keloids

Being tested

Dermatix, Dermatix Ultra

Medical subject headings

Cicatrix, Hypertrophic, Keloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• DermatixDevice

  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 UltraDevice

  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).

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

   Measured: 6 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Jul 2026
2. Study startJul 2026 (estimated)
3. Primary completionOct 2026 (estimated)
4. Study completionDec 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Hypertrophic ScarsStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.