Placebo MNA for Training for Basal Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Beer Dermatology, West Palm Beach, FLBasal Cell CarcinomaDoxorubicin-containing MNA - CombinationProduct
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Basal Cell Carcinoma

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Up to 4 weeks after the last array application to a subject

Week 2
Number of subjects with dose-limiting toxicity and treatment-related adverse events by CTCAE v4.0
Week 4
Number of subjects with Eradication of Basal Cell Cancer based on Histologic Analysis

Trial Safety

Trial Design

5 Treatment Groups

Doxorubicin-containing MNA - 200 µg
1 of 5
Doxorubicin-containing MNA - 50 µg
1 of 5
Doxorubicin-containing MNA - 100 µg
1 of 5
Placebo MNA for Training
1 of 5
Placebo-containing MNA
1 of 5

Active Control

Experimental Treatment

Non-Treatment Group

25 Total Participants · 5 Treatment Groups

Primary Treatment: Placebo MNA for Training · Has Placebo Group · Phase 1 & 2

Placebo MNA for Training
Drug
Experimental Group · 1 Intervention: Placebo-containing MNA · Intervention Types: Drug
Doxorubicin-containing MNA - 200 µg
CombinationProduct
ActiveComparator Group · 1 Intervention: Doxorubicin-containing MNA · Intervention Types: CombinationProduct
Doxorubicin-containing MNA - 50 µg
CombinationProduct
ActiveComparator Group · 1 Intervention: Doxorubicin-containing MNA · Intervention Types: CombinationProduct
Placebo-containing MNA
Drug
PlaceboComparator Group · 1 Intervention: Placebo-containing MNA · Intervention Types: Drug
Doxorubicin-containing MNA - 100 µg
CombinationProduct
ActiveComparator Group · 1 Intervention: Doxorubicin-containing MNA · Intervention Types: CombinationProduct

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 weeks after the last array application to a subject

Who is running the clinical trial?

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

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.