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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks after the last array application to a subject
Awards & highlights

Study 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.

Timeline

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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

SkinJect, Inc.Lead Sponsor
1 Previous Clinical Trials
13 Total Patients Enrolled
Susan M ButtlerStudy DirectorSkinJect, Inc.

Media Library

Doxorubicin-containing MNA (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04928222 — Phase 1 & 2
Basal Cell Carcinoma Research Study Groups: Doxorubicin-containing MNA - 100 µg, Placebo MNA for Training
Basal Cell Carcinoma Clinical Trial 2023: Doxorubicin-containing MNA Highlights & Side Effects. Trial Name: NCT04928222 — Phase 1 & 2
Doxorubicin-containing MNA (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04928222 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participants involved in this clinical research?

"Affirmative. As outlined on clinicaltrials.gov, this medical trial first opened for recruitment on September 24th 2021 and was last updated August 10th 2022 - actively seeking 25 participants from 2 distinct locations."

Answered by AI

Is the age criterion for this experiment limited to individuals under 55 years of age?

"Those who apply for this trial must be between 18 to 75 years old. There are 95 studies available for minors and 325 research opportunities designated for seniors above the age of 65."

Answered by AI

Is there an ongoing recruitment of participants for this clinical trial?

"Clinicaltrials.gov attests that this medical research is currently searching for participants, having been initially posted on September 24th 2021 and most recently amended on August 10th 2022."

Answered by AI

What maladies have been demonstrated to be remedied by Placebo MNA for Training?

"Placebo MNA for Training is habitually utilized to treat lymphoma and Hodgkin's, as well as other diseases such as carcinoma, bronchogenic, neuroblastoma (NB), and Sezary Syndrome."

Answered by AI

Does this research endeavor mark a novel application of methodology?

"Since 1997, Placebo MNA for Training has been the subject of clinical investigation. Alfacell's first trial concerning this medication took place that same year and involved 300 participants. After receiving Phase 3 approval, there are currently 360 trials underway in 66 different nations and 1941 cities worldwide."

Answered by AI

Are there any prior studies which have utilized Placebo MNA for Training?

"The Placebo MNA for Training protocol was first implemented at Spectrum Health Hospital - Butterworth Campus in 1997. Since then, 677 trials have been completed and 360 are currently on-going with many based out of West Palm Beach, Florida."

Answered by AI

Do I meet the qualifications necessary to participate in this medical experiment?

"This clinical trial is open to 25 men and women aged 18-75 with a diagnosis of basal cell carcinoma. In order to qualify, subjects must also fulfill the following criteria: general good health as assessed by the investigator, minimum granulocytes and platelets counts, serum creatinine below twice the upper limit of normal (ULN), AST, ALT, LDH and alkaline phosphatase all at or lower than three times ULN; no other clinically significant abnormal findings in medical history or physical examination; willingness to adhere to instructions from research team and sign informed consent form prior to study procedures; BCC confirmed histologically via"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)
2021. "Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04928222.
~7 spots leftby Apr 2025
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