Hypertrophic ScarsNCT07684573
Scar Gel Product Family Clinical Investigation
An observational study of Hypertrophic Scars and Keloids, run by Hanson Medical, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Hypertrophic Scars, Keloids
- What is being tested?
- Dermatix and Dermatix Ultra
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: PMCF Investigation to Compare the Clinical Performance/Benefit of Dermatix With Dermatix Ultra
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.
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Recent Scar | Patients at risk of developing a hypertrophic or keloid scar, aged 3 years and older. Receives: Device: Dermatix; Device: Dermatix Ultra | |
| Older Scars | Patients with existing scars, aged 3 years and older, Receives: Device: Dermatix; Device: Dermatix Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (1)
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:
- 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).
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.
- First posted6 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionOct 2026 (estimated)
- 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.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanson Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684573
- Sponsor's protocol ID
- PDPROJ-4-CI-P
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PMCF Investigation to Compare the Clinical Performance/Benefit of Dermatix With Dermatix Ultra
- ClinicalTrials.gov ID
- NCT07684573
- Acronym / sponsor ID
- PDPROJ-4-CI-P
- Conditions
- Hypertrophic Scars, Keloids
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hanson Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recent Scar | – | Device: Dermatix, Device: Dermatix UltraPatients at risk of developing a hypertrophic or keloid scar, aged 3 years and older. |
| Older Scars | – | Device: Dermatix, Device: Dermatix UltraPatients with existing scars, aged 3 years and older, |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermatixPatients 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). | Device | Older Scars, Recent Scar |
| Dermatix UltraPatients 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). | Device | Older Scars, Recent Scar |
Primary outcome
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
1 secondary outcome
Satisfaction, Change from Baseline, Complications
Time frame: 6 months of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Scars and Keloids, run by Hanson Medical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale (VSS) (time frame: 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.