Scar Gel Product Family Clinical Investigation

NCT07684573 | Not Yet Recruiting FDA Device

• 1 other identifier: PDPROJ-4-CI-P
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertrophic Scars; Keloids

Outcome Measures

Primary Outcomes (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

  6 months of treatment

Secondary Outcomes (1)

• Satisfaction, Change from Baseline, Complications

  6 months of treatment

Study Arms (2)

Recent Scar

Patients at risk of developing a hypertrophic or keloid scar, aged 3 years and older.

Device: Dermatix; Device: Dermatix Ultra

Older Scars

Patients with existing scars, aged 3 years and older,

Device: Dermatix; Device: Dermatix Ultra

Interventions

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).

Older Scars; Recent Scar

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).

Older Scars; Recent Scar

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanson Medical, Inc.: lead

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Keloid

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06