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New combo therapy aims to treat skin cancers without scarring

NCT ID NCT06623201

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a combination of blue-light photodynamic therapy (a light treatment that kills cancer cells) and the drug sonidegib for people with multiple basal cell carcinomas. The goal is to see if this approach can effectively treat the cancers while avoiding the scarring caused by standard freezing or surgery. About 20 adults with at least 3 skin lesions will participate.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Patients will be included in the study based on the following criteria: 1. Male or females, at least 18 years of age. 2. Diagnosis of BCC with at least 3 nodular lesions that measure 0.5 cm to 5 cm in diameter, located on the head and neck, trunk or extremities. 3. Diagnosis must be confirmed clinically at baseline with 1-3 lesions having been biopsied no sooner than 2 weeks prior to treatment. 4. Patients who may have high burden of disease (i.e., large lesions), who are non-surgical candidates or who refuse surgery. 5. Non-surgical candidates, who may be able to undergo resection of selected single, individual lesion, but may not tolerate extensive surgery, may have many co morbidities, may be prone to complications. 6. Patients in whom surgery or radiation therapy may be impractical. 7. Primary lesions may be acceptable for enrollment. 8. Within normal limit hematopoietic capacity, hepatic and renal function. Values outside those limits may be allowed at the discretion of the PI, if they are determined as not clinically significant. 9. Evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial. 10. Ability to understand and the willingness to sign a written informed consent document in English. Exclusion Criteria Patients will be excluded from the study based on the following criteria: 1. Sexually active women of childbearing (WOCBP)\* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for 20 months after the final dose of treatment. Highly effective contraceptive measures include: 1. Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation 2. Intrauterine device (IUD); intrauterine hormone-releasing system 3. Bilateral tubal ligation; 4. Vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the WOCBP study subject); 5. and/or sexual abstinence. * Childbearing potential refers to a female who has reached menarche, has not had a surgical sterilization procedure (such as a hysterectomy or bilateral oophorectomy), and is not postmenopausal. Menopause is defined as 12 consecutive months of amenorrhea without other biological causes. Furthermore, for females under 55 years old, a serum follicle-stimulating hormone level greater than 40 mIU/mL must be documented to confirm menopause. 2. Sexually active males who are unwilling to use a condom with female partners of childbearing potential, during the study, and for at least 8 months after the last dose of treatment. 3. Subjects who plan on donating blood or blood products during the study and for at least 20 months after the last dose of treatment. Male subjects must agree not to donate sperm during the study and for at least 8 months after the last dose of treatment. 4. Target lesions of basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular). 5. Any BCC that may require Mohs surgery for definitive control as a target lesion. 6. Subjects with porphyria's or known hypersensitivity to porphyrins. 7. Subjects with known photosensitivity diseases. 8. Subjects previously treated with a systemic photosensitizer within 4 months of screening date. 9. Subjects who desire to get pregnant a female of childbearing potential within the next 1.5 years. 10. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 11. Life expectancy less than one year. 12. Inability or unwillingness to swallow capsules. 13. Have a history of alcohol of substance abuse, unless in full remission for greater than 6 months prior to the screening visit (Day 0) when the consent form is signed. 14. Having used any of the following treatment within 6 months before the baseline visit: * hedgehog pathway inhibitor, biologics, or chemotherapy * topical chemotherapy agents including Imiquimod, fluorouracil,) to the selected treatment lesion sites within 3 weeks. 15. Currently undergoing treatment with photodynamic therapy within 3 weeks before baseline visit. 16. Subjects who have received any type of solid organ transplant. 17. Subjects taking immunosuppressive medications at the screening visit that interact with Sonidegib at the screening visit unless approved by the investigator.. 18. Participation in other study using an investigational or experimental therapy or procedure within 4 weeks or 5 half-lives (whichever is longer) before the screening visit and/or during study participation. Subjects cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study. 19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 20. Subjects unable or unwilling to comply with the study visit schedule and requirements of the study. 21. Subjects unable to speak and read the English language. 22. A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures. 23. A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Medical Dermatology Specialists

    RECRUITING

    Phoenix, Arizona, 85006, United States

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Other studies related to the condition(s) this trial covers.