RECRUITING

The Purpose of This Study is to Evaluate the Safety and Efficacy of D-MNA in Adult Patients With Nodular Basal Cell Carcinoma

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of the study is to learn about the safety and how effective two different strengths of D-MNA compared to a placebo (a look-alike substance that contains no drug) in the treatment of nodular basal cell skin cancer

Official Title

A Randomized, Double-Blinded, Placebo Controlled Trial to Evaluate the Safety and Efficacy of a Doxorubicin Microneedle Array (D-MNA) for the Treatment of Nodular Basal Cell Carcinoma in Adults

Quick Facts

Study Start:2024-09-03

Study Completion:2025-06-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06608238

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or non-pregnant female ≥ 18 years of age. 2. Clinical diagnosis of a primary, previously untreated, histologically confirmed nodular Basal Cell Carcinoma (nBCC) lesion suitable for excision (at end of the study) with a minimum diameter of 0.5 cm and with a maximum longest diameter of 1.3 cm at the time of biopsy and Visit 2/Baseline. 3. Willing to refrain from exposure to excessive direct sunlight or ultraviolet light and to avoid the use of tanning beds for the duration of the study. 4. Willing and able to receive the test article treatments, comply with study instructions, and commit to all follow-up visits for the duration of the study.	1. Pregnant, lactating, or planning to become pregnant. 2. nBCC is located on the face, scalp, digits, mucosa, or skin that is scarred or previously treated with radiation. 3. History of treated nBCC lesion recurrence or basal cell nevus syndrome. 4. Immunocompromised, based on medical condition (e.g., human immunodeficiency virus), medication use, or other factors. 5. Active malignancy, excluding non-metastatic prostate cancer, other cutaneous basal or squamous cell carcinomas, and carcinoma of the cervix. 6. Used systemic chemotherapeutic agents within the 12 months prior to Visit 2/Baseline. 7. Clinical laboratory results at Visit 1/Screening within the following ranges: (a) granulocytes \&lt; 2,000/mm3, (b) platelets \&lt;50,000/mm3, (c) serum creatinine greater than 2 times the upper limit of normal (ULN), (d) aspartate aminotransferase, alkaline aminotransferase, lactate dehydrogenase, or alkaline phosphatase greater than 3 times the ULN. 8. History of sensitivity to any of the ingredients in the test articles . 12. Used topical immunomodulators within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy. 9. Used the following topical agents within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy: aminolevulinic acid, 5-fluorouracil, diclofenac, ingenol mebutate, tirbanibulin, or imiquimod. 10. Has been treated with liquid nitrogen, surgical excision or curettage within 2 cm of the Target Lesion within 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy. 11. Currently enrolled in an investigational drug, biologic, or device study. 12. Used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to enrollment into the study. 13. Unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity)

Inclusion Criteria

Exclusion Criteria

1. Male or non-pregnant female ≥ 18 years of age.
2. Clinical diagnosis of a primary, previously untreated, histologically confirmed nodular Basal Cell Carcinoma (nBCC) lesion suitable for excision (at end of the study) with a minimum diameter of 0.5 cm and with a maximum longest diameter of 1.3 cm at the time of biopsy and Visit 2/Baseline.
3. Willing to refrain from exposure to excessive direct sunlight or ultraviolet light and to avoid the use of tanning beds for the duration of the study.
4. Willing and able to receive the test article treatments, comply with study instructions, and commit to all follow-up visits for the duration of the study.

1. Pregnant, lactating, or planning to become pregnant.
2. nBCC is located on the face, scalp, digits, mucosa, or skin that is scarred or previously treated with radiation.
3. History of treated nBCC lesion recurrence or basal cell nevus syndrome.
4. Immunocompromised, based on medical condition (e.g., human immunodeficiency virus), medication use, or other factors.
5. Active malignancy, excluding non-metastatic prostate cancer, other cutaneous basal or squamous cell carcinomas, and carcinoma of the cervix.
6. Used systemic chemotherapeutic agents within the 12 months prior to Visit 2/Baseline.
7. Clinical laboratory results at Visit 1/Screening within the following ranges: (a) granulocytes \&lt; 2,000/mm3, (b) platelets \&lt;50,000/mm3, (c) serum creatinine greater than 2 times the upper limit of normal (ULN), (d) aspartate aminotransferase, alkaline aminotransferase, lactate dehydrogenase, or alkaline phosphatase greater than 3 times the ULN.
8. History of sensitivity to any of the ingredients in the test articles .
12. Used topical immunomodulators within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.
9. Used the following topical agents within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy: aminolevulinic acid, 5-fluorouracil, diclofenac, ingenol mebutate, tirbanibulin, or imiquimod.
10. Has been treated with liquid nitrogen, surgical excision or curettage within 2 cm of the Target Lesion within 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.
11. Currently enrolled in an investigational drug, biologic, or device study. 12. Used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to enrollment into the study.
13. Unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity)

Contacts and Locations

Study Contact

Marietta P Radona, MD

CONTACT

858-571-1800

ClinicalResearch@therapeuticsinc.com

Study Locations (Sites)

Site #4

Fresno, California, 93720

United States

Site #6

San Diego, California, 92108

United States

Site #1

Rolling Meadows, Illinois, 60008

United States

Site #5

Mandeville, Louisiana, 70448

United States

Site #3

Highlands, New Jersey, 07716

United States

Site#2

Knoxville, Tennessee, 37909

United States

Collaborators and Investigators

Sponsor: SkinJect, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-03

Study Completion Date2025-06-02

Study Record Updates

Study Start Date2024-09-03

Study Completion Date2025-06-02

Terms related to this study

Additional Relevant MeSH Terms

Nodular Basal Cell Carcinoma