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Microneedle Array Plus Doxorubicin for Cutaneous Squamous Cell Cancer

This study is testing a new way to treat cutaneous squamous cell carcinoma (cSCC), a type of skin cancer. It uses a small patch called a Microneedle Array (MNA) that has tiny needles loaded with a chemotherapy drug called Doxorubicin. The patch delivers a very small dose of the drug directly to the skin cancer. The main goal is to see how safe this treatment is by tracking any side effects. You might be able to join if you are 18 or older, have a confirmed diagnosis of cSCC that can be removed by surgery, and your tumor is between 5mm and 100mm in size. The study aims to enroll 48 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 48 participants.
What's involved
You would have the Microneedle Array Doxorubicin (MNA-D) patch applied to your cSCC for 20 minutes, once a week, for a total of four weeks.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the start of the study up to 8 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05377905

Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Falo, Louis, MD
~48 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:Microneedle Array Doxorubicin (MNA-D)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of adverse events grade 2 or higher to evaluate safety of MNA-D patches in cSCC
Measured over Baseline up to week 8

Conditions

Cutaneous Squamous Cell Carcinoma
Skin Cancers - Squamous Cell Carcinoma

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Skin Squamous Cell Carcinoma

NCT05377905

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Oleg E Akilov, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Charity L Ruhl, LPN
[email protected]
1-412-647-2013
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Exclusion

\>4 mm depth;
Clark level IV;
perineural invasion, lymphovascular invasion;
primary site on the ear or non-glabrous lip;
location in the hands or feet;
large size: ≥10 mm on neck or pretibial area; ≥20 mm on trunk or extremities;
indistinct borders;
rapid growth;
recurrent lesion;
lesion in site of chronic inflammation or prior radiation therapy;
presence of neurologic symptoms; or • poorly differentiated, and aggressive histopathologic subtypes. 2. Subjects with uncontrolled pain that would preclude participation in the study. 3. Subjects who are pregnant or lactating. 4. Subjects who have sensitivity to drugs that provide local anesthesia. 5. Impaired cardiac function or clinically significant cardiac disease, including any of the following:
Symptomatic congestive heart failure requiring treatment
Clinically significant cardiac arrhythmia
Uncontrolled hypertension
Corrected QT interval (QTc) \>470 msec at Screening or congenital long QT syndrome
Acute myocardial infarction or unstable angina pectoris \< 3 months prior to the first dose
New York Heart Association Functional Class III or higher (i.e. marked limitation of physical activity due to symptoms, or unable to carry on any physical activity without discomfort) 6. Subjects with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix. 7. Active, known, or suspected autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.

What this trial measures

  • Number of adverse events grade 2 or higher to evaluate safety of MNA-D patches in cSCCBaseline up to week 8

    Evaluated by assessing adverse events grade 2 or higher related to the MNA-D intervention