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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Falo, Louis, MD
Study ID
NCT05377905
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Microneedle Array Doxorubicin (MNA-D) — DRUG
    The Microneedle array patch is loaded/prepared with a total dose of 50 micrograms of Doxorubicin and is applied to a single selected cSCC remnant for a period of 20 minutes for a total of 4 weekly applications

Study Details

The purpose of this study is to test a new method of experimental treatment for cutaneous squamous cell skin cancer, using small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy agent. The overall goal of this study is to test the safety and effectiveness of these patches. The investigators have established the highest tolerated dose at 50 micrograms in a previous study for a different type of cancer that affects the skin. The investigators will thoroughly evaluate the skin where the patches are applied.

Key Dates

Start date
Sep 13, 2023
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Microneedle Array Doxorubicin (MNA-D)
    Immunocompetent and immuno-incompetent subjects will receive the MNA-D patch on 4 subsequent visits for a 20 minute time period at each application and will include patients who have competent immune systems with cSCC meeting all other inclusion/exclusion criteria and patients considered immuno-incompetent post transplant with cSCC meeting all other inclusion/exclusion criteria.

Primary Outcome Measure

Number of adverse events grade 2 or higher to evaluate safety of MNA-D patches in cSCC [ Time Frame: Baseline up to week 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Charity L Ruhl, LPN
[email protected]
4126472013
Nicolena Verardi, PA-C
[email protected]
412-864-3682
Oleg E Akilov, MD, PhD (PRINCIPAL_INVESTIGATOR)
Louis D Falo, MD, PhD (SUB_INVESTIGATOR)
Melissa M Pugliano-Mauro, MD (SUB_INVESTIGATOR)
Timothy Patton, DO (SUB_INVESTIGATOR)
Jason Luke, MD (SUB_INVESTIGATOR)
Nicolena Verardi, PA-C (SUB_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
University of Pittsburgh Medical Center· Pittsburgh, PA

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