Silicone gel showdown: which scar treatment works better?
NCT ID NCT07684573
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This study compares two silicone gel formulations, Dermatix and Dermatix Ultra, to see if one is better at improving the appearance and symptoms of raised scars (keloids and hypertrophic scars). About 150 people with existing or new scars will use one of the gels twice daily for six months. Researchers will measure changes in scar color, thickness, flexibility, and itchiness, as well as patient satisfaction.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- silicone gel (Dermatix and Dermatix Ultra)
- What this could lead to
- If one formulation proves superior, it could offer a more effective option for reducing scar symptoms and improving appearance.
- What could go wrong
- This is a small, open-label study comparing two similar products, so differences may be subtle or not clinically meaningful. Results may not apply to all scar types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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3 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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