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
Last Updated: 2024-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-09-03
2025-06-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A
D-MNA 200 mcg, intradermal patch, given once weekly for 2 weeks.
D-MNA 200 mcg
D-MNA , (doxorubicin) patch, 200 mcg
Arm B
D-MNA 100 mcg intradermal patch, given once weekly for 2 weeks
D-MNA 100 mcg
D-MNA (doxorubicin) patch, 100 mcg
Arm C
P-MNA, intradermal patch, given once weekly for 2 weeks
Placebo
P-MNA patch, placebo
Interventions
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D-MNA 200 mcg
D-MNA , (doxorubicin) patch, 200 mcg
D-MNA 100 mcg
D-MNA (doxorubicin) patch, 100 mcg
Placebo
P-MNA patch, placebo
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
85 Years
ALL
No
Sponsors
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SkinJect, Inc.
INDUSTRY
Responsible Party
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Locations
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Site #4
Fresno, California, United States
Site #6
San Diego, California, United States
Site #1
Rolling Meadows, Illinois, United States
Site #5
Mandeville, Louisiana, United States
Site #3
Highlands, New Jersey, United States
Site#2
Knoxville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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SKNJCT-003
Identifier Type: -
Identifier Source: org_study_id
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