Doxorubicin Microneedles for Basal Cell Carcinoma

Not currently recruiting at 1 trial location

Overseen By Michael J Fare

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: SkinJect, Inc.

Must not be taking: Anticoagulants, Platelet inhibitors

Disqualifiers: Pregnancy, Breastfeeding, Unstable conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating basal cell carcinoma, a common type of skin cancer, using microneedles that dissolve into the skin to deliver doxorubicin. The first part of the trial examines how these microneedles work on healthy skin, while the second part applies them to skin cancer patients to assess their effectiveness. Individuals who have not previously treated their basal cell carcinoma and can keep the area out of sunlight may be suitable candidates for this trial. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those on certain blood thinners and systemic immunosuppressive treatments. It's best to discuss your specific medications with the trial team.

What prior data suggests that the doxorubicin microneedle arrays are safe for humans?

Research has shown that the doxorubicin-containing microneedle array (D-MNA) treatment was well-tolerated in previous studies. These studies found no dose-limiting toxicities, meaning the doses did not cause harmful side effects that would prevent dose escalation. Importantly, no serious adverse effects were reported, which is reassuring for those considering joining the trial.

Additionally, the treatment successfully cleared basal cell carcinoma in over 60% of patients, effectively treating the condition without causing serious problems. Overall, past findings suggest that the treatment is safe for humans, making it a promising option for trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for basal cell carcinoma?

Unlike the standard creams and surgeries for basal cell carcinoma, doxorubicin microneedles offer a unique delivery method. These microneedles deliver doxorubicin, a chemotherapy drug, directly into the tumor. This localized approach could minimize side effects typically associated with systemic chemotherapy, offering a more targeted and less invasive treatment option. Researchers are excited about this because it has the potential to be both more effective and less harmful to healthy tissue compared to traditional treatments.

What evidence suggests that doxorubicin-containing microneedles could be effective for basal cell carcinoma?

This trial will compare the effectiveness of Doxorubicin-containing microneedle arrays (D-MNA) with placebo-containing microneedle arrays for treating basal cell carcinoma (BCC). Research has shown that microneedle patches with doxorubicin may effectively treat BCC, a common type of skin cancer. In previous studies, more than 60% of patients experienced complete cancer clearance with this treatment. Importantly, no serious side effects or issues with overdosing occurred. This suggests that D-MNA is both effective and safe for individuals with BCC. Early results from other trials also demonstrated positive effects on cancer spots, supporting its potential as a noninvasive treatment option. ^{1 3 6 7 8}

Who Is on the Research Team?

Susan M Buttler

Principal Investigator

SkinJect, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject must sign an Informed Consent Form prior to any study specific procedures

Subject must be willing to adhere to the instructions of the investigator and research team

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

Exclusion Criteria

Evidence of clinically significant, unstable medical conditions

I have a genetic condition that causes skin cancer.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Training phase for application of placebo microneedle arrays in healthy volunteers

2 weeks

Treatment

Application of doxorubicin-containing microneedle arrays to subjects with basal cell cancer

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Doxorubicin-containing MNA
• Placebo-containing MNA

Trial Overview 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.

How Is the Trial Designed?

Group I: Placebo MNA for Training Experimental Treatment 1 Intervention

Training phase for application of arrays

Group II: Doxorubicin-containing MNA - 100 µg Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

SkinJect, Inc.

Lead Sponsor

Trials

3

Recruited

100+

Published Research Related to This Trial

In a study of 90 patients with advanced gynecologic cancers treated with pegylated liposomal doxorubicin (PLD) at a lower dose of 40 mg/m², 37% experienced skin reactions, primarily within the first few cycles of treatment.

Severe skin toxicity (grade 2 or higher) was rare, occurring in only 11% of patients, and most cases were manageable with dose reductions, allowing 93% of those who continued treatment to avoid further skin issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin toxicity associated with pegylated liposomal doxorubicin (40 mg/m2) in the treatment of gynecologic cancers. Kim, RJ., Peterson, G., Kulp, B., et al.[2013]

Citations

1. onclive.com onclive.com/view/d-mna-displays-potential-as-noninvasive-therapy-in-basal-cell-carcinoma-of-the-skin

D-MNA Displays Potential as Noninvasive Therapy in ... D-MNA treatment for BCC showed no dose-limiting toxicities or serious adverse effects, with over 60% achieving complete clinical clearance. The ...

2. medicuspharma.com medicuspharma.com/medicus-pharma-ltd-provides-update-on-doxorubicin-containing-novel-microneedle-array-d-mna-clinical-development-program-for-the-treatment-of-basal-cell-carcinoma-bcc-of-the-skin-and-reports-secon/

Medicus Pharma Provides Update on Doxorubicin Containing Novel Microneedle Array (D-MNA) Clinical Development Program for the Treatment of Basal Cell ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03646188?cond=basal%2520cell%2520carcinoma%26term=Doxorubicin%26rank=1

Study Details | NCT03646188 | Dose Escalation Trial to ... This is a Phase I study in participants with superficial or nodular Basal Cell Carcinoma (BCC), designed to assess dose limiting toxicities and maximum ...

4. cancernetwork.com cancernetwork.com/view/fda-accepts-type-c-meeting-for-doxorubicin-mna-in-basal-cell-carcinoma-of-the-skin

FDA Accepts Type C Meeting for Doxorubicin-MNA in ... D-MNA achieved complete clinical clearance in 60% of patients, with no dose-limiting toxicities or serious adverse effects observed in those ...

5. drug-dev.com drug-dev.com/transdermal-delivery-skinjects-doxorubicin-loaded-dissolvable-microneedle-array-d-mna-a-revolutionary-approach-to-transdermal-drug-delivery/

SkinJect's Doxorubicin-Loaded Dissolvable Microneedle ... Efficacy: Preliminary assessments indicated positive responses in Basal Cell Carcinoma lesions, with 6 patients showing complete lesion response at each dose ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04928222

Study Details | NCT04928222 | Placebo Microneedles in ... Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/​Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II) · Study Overview.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06608238

NCT06608238 | The Purpose of This Study is to Evaluate ... A double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of D-MNA which is administered as an intradermal injection.

8. medicuspharma.com medicuspharma.com/medicus-pharma-ltd-publishes-phase-1-clinical-study-report-demonstrating-safety-tolerability-in-all-participants-with-basal-cell-carcinoma/

Medicus Pharma Ltd. Publishes Phase 1 Clinical Study ... The investigational product, D-MNA was found to be safe and well-tolerated across all dose levels in all thirteen (13) participants enrolled in the study.