Trial Title:
The Purpose of This Study is to Evaluate the Safety and Efficacy of D-MNA in Adult Patients With Nodular Basal Cell Carcinoma
NCT ID:
NCT06608238
Condition:
Nodular Basal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Basal Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
60 subjects randomized in a 1:1:1 ratio to receive placebo or one of the D-MNA doses
weekly for three doses.
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
Double-blinded (Participant and Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
D-MNA 200 mcg
Description:
D-MNA , (doxorubicin) patch, 200 mcg
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
D-MNA 100 mcg
Description:
D-MNA (doxorubicin) patch, 100 mcg
Arm group label:
Arm B
Intervention type:
Other
Intervention name:
Placebo
Description:
P-MNA patch, placebo
Arm group label:
Arm C
Summary:
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
Detailed description:
A double-blind, randomized, placebo-controlled study designed to evaluate the safety and
efficacy of D-MNA which is administered as an intradermal injection in subjects with
nodular Basal Cell Carcinoma (nBCC).
About 60 subjects will be enrolled. Enrolled subjects will be randomly allocated to
receive D-MNA or placebo injection on the identified target lesion once weekly for 3
weeks.
After two weeks, the target lesion will be excised.
An Interim Analysis will be done after 26-30 subjects would have completed Visit 5/
Excision Visit.
Criteria for eligibility:
Criteria:
Inclusion 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.
Exclusion Criteria:
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 < 2,000/mm3, (b) platelets <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)
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Site #4
Address:
City:
Fresno
Zip:
93720
Country:
United States
Status:
Recruiting
Contact:
Phone:
559-446-0285
Email:
e.southland@raodermatology.com
Facility:
Name:
Site #6
Address:
City:
San Diego
Zip:
92108
Country:
United States
Status:
Not yet recruiting
Contact:
Phone:
858-274-4226
Email:
jwiliams@paradigm-research.com
Facility:
Name:
Site #1
Address:
City:
Rolling Meadows
Zip:
60008
Country:
United States
Status:
Recruiting
Contact:
Last name:
Research Study Coordinator
Phone:
847-392-5440
Email:
davidbukowski6@gmail.com
Facility:
Name:
Site #5
Address:
City:
Mandeville
Zip:
70448
Country:
United States
Status:
Recruiting
Contact:
Phone:
985-900-2400
Email:
sbailey@clinicaltrialsmgt.com
Facility:
Name:
Site #3
Address:
City:
Highlands
Zip:
07716
Country:
United States
Status:
Recruiting
Contact:
Phone:
732-872-2007
Email:
mst122@rwjms.rutgers.edu
Facility:
Name:
Site#2
Address:
City:
Knoxville
Zip:
37909
Country:
United States
Status:
Recruiting
Contact:
Phone:
865-249-0185
Email:
KAHall@dermaknox.com
Start date:
September 3, 2024
Completion date:
June 2, 2025
Lead sponsor:
Agency:
SkinJect, Inc.
Agency class:
Industry
Source:
SkinJect, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06608238
