Doxorubicin Microneedles for Basal Cell Carcinoma

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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses dissolvable microneedles to deliver medication. It studies how these needles dissolve in healthy volunteers and tests their effectiveness in delivering a cancer drug to patients with basal cell cancer. Dissolving microneedles (DMNs) are a drug delivery system that encapsulates drugs within a biodegradable polymer matrix, allowing for minimally invasive delivery into the skin.

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 data supports the effectiveness of the treatment Doxorubicin-containing MNA for basal cell carcinoma?

The research on microneedles (MNs) shows they can effectively deliver drugs deep into the skin, which is important for treating basal cell carcinoma. Additionally, similar treatments using microneedles for other drugs have shown successful localized delivery and effectiveness in treating skin lesions. ^{1 2 3 4 5}

Is Doxorubicin Microneedles safe for humans?

Doxorubicin, especially in its liposomal form, can cause skin-related side effects like rashes and hand-foot syndrome, but it is generally considered to have a favorable side effect profile compared to standard doxorubicin. These side effects have been observed in treatments for various cancers, indicating that while it is generally safe, skin reactions are common. ^{6 7 8 9 10}

How is the Doxorubicin-containing MNA treatment different from other treatments for basal cell carcinoma?

The Doxorubicin-containing MNA treatment is unique because it uses microneedles to deliver the drug directly into the skin, allowing for localized treatment of basal cell carcinoma. This method is minimally invasive and can target deeper skin lesions more effectively than traditional topical treatments. ^{1 2 11 12 13}

Research Team

Susan M Buttler

Principal Investigator

SkinJect, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intradermal Delivery of a Near-Infrared Photosensitizer Using Dissolving Microneedle Arrays. [2019]

2. Cyprus pubmed.ncbi.nlm.nih.gov

Nanoparticles as drug carrier system of 5-fluorouracil in local treatment of patients with superficial basal cell carcinoma. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of laser-assisted combination chemotherapy: A follow-up study of treatment with 5-fluorouracil and cisplatin for basal cell carcinoma. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Immunocryosurgery for non-superficial basal cell carcinomas ≤ 20 mm in maximal diameter: Five-year follow-up. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Plum-blossom needling enhanced the effect of photodynamic therapy on basal cell carcinoma. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Striking follicular eruption to pegylated liposomal doxorubicin. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Skin toxicity associated with pegylated liposomal doxorubicin (40 mg/m2) in the treatment of gynecologic cancers. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Experimental model of doxorubicin extravasation in the mouse. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Histologic patterns of polyethylene glycol-liposomal doxorubicin-related cutaneous eruptions. [2018]

10. Greece pubmed.ncbi.nlm.nih.gov

Phase II trial of doxil for patients with metastatic melanoma refractory to frontline therapy. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Cisplatin and doxorubicin for invasive basal cell carcinoma of the eyelids. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

No-needle jet intradermal aminolevulinic Acid photodynamic therapy for recurrent nodular Basal cell carcinoma of the nose: a case report. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Intralesional bleomycin as alternative therapy in the treatment of multiple basal cell carcinomas. [2006]