Pill before surgery may reduce scarring for skin cancer patients
NCT ID NCT03534947
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether taking a daily pill called sonidegib for 12 weeks could shrink basal cell carcinomas in cosmetically sensitive areas like the face. The goal was to make surgery less invasive, reduce scarring, or even avoid surgery altogether by using only a topical cream afterward. Sixteen adults with this type of skin cancer participated in the pilot study.
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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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16 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Mar 2025
- 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. * Written informed consent. * Histologically confirmed, resectable, invasive basal cell carcinoma. * Site and size of BCC considered to be in a cosmetically challenging position for surgery. * Patient has expressed concerns of the cosmetic outcome of surgery. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Ability to swallow and retain oral medication. * Anticipated life expectancy of \> 12 months. * Adequate organ function as demonstrated by blood tests. * Willing to abstain from blood donations for 20 months from the last dose of sonidegib. * Men with female partner of childbearing potential to use effective contraception from 14 days prior to study treatment until 6 months after the last dose. * Female patients with active contraception or no menstrual cycle for \>12 months Exclusion Criteria: * Inoperable basal cell carcinoma tumours. * A concurrent cancer diagnosis requiring any systemic anti-cancer therapy. * Serious or unstable pre-existing medical conditions or other conditions or laboratory abnormalities that could interfere with the patient's safety, consent, or compliance. * History of malabsorption or other conditions that would interfere with the absorption of sonidegib. * Known psychiatric or substance abuse disorders that would interfere with cooperation and compliance with the requirements of the trial. * Prior treatment with hedgehog pathway inhibitors. * Concomitant medications that may result in increased or decreased bioavailability of sonidegib. * Patients with neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, rhabdomyolysis, amyotrophic lateral sclerosis and spinal muscular atrophy) due to an increased risk of muscle toxicity with sonidegib. * Male patients expecting to father children or donate sperm during the 12 weeks of sonidegib treatment and for a further 6 months from the end of treatment. * Pregnant or breastfeeding women
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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.
Contacts and locations
Locations
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Melanoma Institute Australia
North Sydney, New South Wales, 2060, Australia
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Other studies related to the condition(s) this trial covers.
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