What side effects are associated with this type of intervention?

Common treatments for Basal Cell Carcinoma (BCC) include surgical excision, Mohs surgery, cryotherapy, topical treatments like 5-fluorouracil (5-FU) and imiquimod, and photodynamic therapy (PDT). Side effects of these treatments can vary: surgical methods may lead to scarring and infection; cryotherapy can cause blistering and pigmentation changes; topical treatments often result in local skin irritation, redness, and peeling; and PDT can cause pain, swelling, and photosensitivity. For localized delivery of doxorubicin via dissolvable microneedles, potential side effects might include localized skin reactions such as redness, swelling, and possible systemic effects of doxorubicin like cardiotoxicity, although these are expected to be minimal due to localized application.

What prior FDA approvals exist?

The FDA has approved several treatments for Basal Cell Carcinoma (BCC), including topical therapies, surgical methods, and systemic treatments. Notably, vismodegib and sonidegib are oral hedgehog pathway inhibitors approved for advanced BCC. While these treatments are systemic, localized delivery methods like the investigational doxorubicin-containing dissolvable microneedle arrays represent a novel approach. This method aims to deliver chemotherapy directly to the cancerous tissue, potentially reducing systemic side effects and improving local efficacy. Although not yet FDA-approved, this approach is being studied for its potential benefits in treating BCC.

What other types of research exist?

Promising novel alternatives for localized treatment of Basal Cell Carcinoma in 2024 include: 1) 3D printed microneedles for localized delivery of cisplatin, which have shown high anticancer activity and tumor regression in preclinical studies. 2) Photodynamic therapy (PDT) using 5-aminolevulinic acid (ALA) or methyl aminolevulinate (MAL), which has been effective in treating actinic keratosis and could be adapted for BCC. 3) Electrochemotherapy, which combines chemotherapy with electrical pulses to enhance drug uptake by cancer cells, showing potential in treating skin cancers. These alternatives offer targeted treatment with potentially fewer systemic side effects.

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Anti-tumor antibiotic

Doxorubicin Microneedles for Basal Cell Carcinoma

Phase 1 & 2

Waitlist Available

Research Sponsored by SkinJect, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy removed ≤25% of the original volume of the target lesion

Subject must have no other clinically significant abnormal findings in medical history, physical examination, or clinical laboratory test results

Must not have

Genetic skin cancer disorder

Prior excisional surgery on the lesion to be treated in this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks after the last array application to a subject

Awards & highlights

Summary

This trial is designed to study the effect of P-MNA (a dissolvable microneedle array) on healthy human volunteers, with the goal of determining how different factors affect the rate and extent of microneedle array dissolution. The trial will be conducted in two parts. In Part II, subjects will be randomized to one of four dose groups to receive either a placebo or a specified amount of doxorubicin in a tip-loaded, dissolvable microneedle array.

Who is the study for?

Healthy adults over 18, with confirmed superficial or nodular basal cell carcinoma (BCC) that hasn't been treated before. Participants must use effective contraception if applicable, have certain blood and organ function test results within normal ranges, and avoid sunlight on the lesion. Excluded are those pregnant or breastfeeding, with unstable conditions, allergies to doxorubicin, recent anticoagulant use, other active malignancies except specified types of cancer.Check my eligibility

What is being tested?

The trial has two parts: Part I tests placebo microneedles in healthy volunteers to study factors affecting microneedle dissolution. Part II is a randomized trial where participants with BCC receive either placebo or varying doses of doxorubicin via dissolvable microneedles to assess efficacy and safety.See study design

What are the potential side effects?

Potential side effects include local skin reactions at the application site such as redness or irritation. Since doxorubicin is being used there may also be risks associated with its systemic absorption like nausea, hair loss, mouth sores and potential impact on blood cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Less than 25% of my target lesion was removed during biopsy.

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I have no significant health issues apart from my current condition.

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My skin cancer lesion fits the size range given.

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I can avoid sunlight on the target lesion for the study duration.

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My skin cancer was confirmed by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a genetic condition that causes skin cancer.

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I have had surgery to remove the lesion that will be treated in this study.

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My cancer has spread to other parts of my body.

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I have responded well to doxorubicin or carboxymethyl cellulose treatment before.

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My skin cancer is in a spot where cutting it out would look bad or isn't wanted.

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I am on medication that weakens my immune system due to another illness.

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I do not have any severe illnesses that are not under control.

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I have a skin condition near my basal cell carcinoma.

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I am currently taking blood thinners.

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I have cancer, but it's not one of the excluded types.

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My basal cell carcinoma has come back at the same spot.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks after the last array application to a subject

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 weeks after the last array application to a subject

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks after the last array application to a subject for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of subjects with Eradication of Basal Cell Cancer based on Histologic Analysis

Number of subjects with dose-limiting toxicity and treatment-related adverse events by CTCAE v4.0

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Placebo MNA for TrainingExperimental Treatment1 Intervention

Training phase for application of arrays

Group II: Doxorubicin-containing MNA - 100 µgActive Control1 Intervention

A doxorubicin-containing array of 100 µg will be applied to subjects.

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Basal Cell Carcinoma (BCC) include surgical excision, Mohs micrographic surgery, topical therapies (e.g., imiquimod, 5-fluorouracil), and photodynamic therapy (PDT). These treatments work by physically removing cancerous tissue, stimulating the immune system to attack cancer cells, or using light-activated drugs to destroy cancer cells. The Doxorubicin-Containing Dissolvable Microneedle Array represents a novel approach by delivering chemotherapy directly to the tumor site, minimizing systemic exposure and potentially reducing side effects. This localized delivery is crucial for BCC patients as it targets the cancer more precisely, enhances drug concentration at the tumor site, and may improve treatment outcomes while preserving surrounding healthy tissue.

Bioorthogonal catalytic patch.A new computational method of modeling and evaluation of dissolving microneedle for drug delivery applications: Extension to theoretical modeling of a novel design of microneedle (array in array) for efficient drug delivery.Recent Advances and Impact of Chemotherapeutic and Antiangiogenic Nanoformulations for Combination Cancer Therapy.