Could a cream make laser treatment for birthmarks more effective?
NCT ID NCT07436611
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tests whether a rapamycin cream, applied after laser treatment, can improve the appearance of port wine stain birthmarks in children aged 10 and under. Thirty participants will receive laser therapy plus either a low or high dose of the cream or a placebo cream for 12 weeks. The goal is to see if the cream leads to greater fading than laser alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rapamycin cream
- What this could lead to
- If it works, this could offer a better way to lighten port wine stain birthmarks by combining a cream with laser treatment.
- What could go wrong
- This is a small, early-phase trial with only 30 children. The cream may not improve results beyond laser alone, and skin irritation is possible.
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.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
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.
- Ages
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Up to 10 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female patients aged ≤ 10 years on the day informed consent is obtained 2. Patients presenting either facial, neck, or upper trunk port-wine stains 3. Port wine stain size of at least 5 cm tall x 2.5 cm wide (2x1 inches) 4. Patients (or their legal representatives) capable of understanding the explanation of the clinical trial, and who give written informed consent for participation 5. Patients (or their legal representatives) able to maintain patient diaries following the instructions of the investigator or sub-investigator 6. Patients (or their guardians) are willing and able to follow instructions to only apply cream to part of their port-wine stain 7. Skin type classified as either I, II, III or IV on the Fitzpatrick scale 8. Patients who are indicated for PDL treatment and accept this treatment 9. Patients who respond to PDL with purpura or blanching Exclusion Criteria: 1. Skin type classified as either V or VI on the Fitzpatrick scale 2. Patients with PWS in extremities and/or acral areas 3. Patients unwilling or unable to carry out the treatment plan or follow-up assessment 4. Patients with serious skin lesions such as erosions or ulcers 5. Patients with known hypersensitivity to any component of the study product 6. Patients who have received rapamycin/sirolimus, everolimus, or temsirolimus within 3 months of enrolment 7. Patients who have received laser therapy or surgical therapy to treat PWS within 3 months prior to trial enrolment 8. Patients who have received 5 or more PDL treatments previously 9. Patients who participated in any other clinical trial within 3 months prior to the day of enrolment 10. Patients judged unsuitable for this clinical trial by the investigator or sub-investigator 11. Pregnant or lactating females 12. Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception\* 13. Patients with immune dysfunction or receiving any form of immunosuppression
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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 places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
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Sant Joan de Déu University Hospital
Barcelona, Catalonia, 08950, Spain
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