Could a simple cream reduce the need for major mole removal surgery?
NCT ID NCT04999631
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether a topical cream called squaric acid dibutyl ester (SADBE) can safely reduce pigment-producing cells in large congenital moles before they are surgically removed. Thirty adults with these birthmarks will apply the cream or a placebo for several weeks before their planned excision. The goal is to see if the treatment lowers the number of melanocytes and lightens the mole, potentially making surgery easier or less extensive.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Squaric acid dibutyl ester (SADBE) applied as a topical solution
- What this could lead to
- If it works, this could point toward a non-surgical way to lighten or shrink congenital moles before removal, potentially reducing scarring or need for extensive surgery.
- What could go wrong
- This is a very early (Phase 1) trial with only 30 people, so it may not show clear benefit. The treatment is topical but could cause skin irritation or allergic reactions.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small 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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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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18 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.
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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: * 18 years of age or older. * Subject or parents willing and able to give informed consent, and assent as appropriate. * Patients who have a clinical diagnosis of CMN with plans for elective non-urgent excision of part or all of their nevus, with nevus surface area of \> 6 cm2. Exclusion Criteria: * Immunosuppressive therapy with glucocorticoid or other systemic immunosuppressant within 4 weeks of recruitment (except for inhaled corticosteroids for asthma). * History of malignancy. * History of organ transplantation. * Known immunosuppressive disease, including infection with HIV. * Severe medical comorbidities (diabetes mellitus requiring insulin, CHF of any severity, MI, CVA, or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease) * Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit. * Subjects who have known hypersensitivity to SADBE or any of its components. * Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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