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

SkinJect

Status and phase: Completed; Phase 2

Conditions: Nodular Basal Cell Carcinoma

Treatments: Other: microneedle array alone; Drug: D-MNA 100 mcg; Drug: D-MNA 200 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06608238

SKNJCT-003

Details and patient eligibility

About

The goal of the study is to investigate the safety and effectivness of the microneedle array alone and in combination with two different doses of doxorubibin (100ug and 200ug) in the treatment of nodular basal cell skin cancer.

Full description

About 60 subjects will be enrolled. Enrolled subjects will be randomly allocated to receive D-MNA or MNA alone 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.

After approximately one half of the subjects were enrolled, the protocol was ammended to enroll a total of 90 patients 1:1:1 and to change the excisional biopsy day from day 29 to day 57; approximately 6 weeks after the last microneedle array application.

Enrollment: 90 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

200 mcg patch

Active Comparator group

Description:

D-MNA 200 mcg, intradermal patch, given once weekly for 2 weeks.

Treatment:

Drug: D-MNA 200 mcg

100mcg patch

Active Comparator group

Description:

D-MNA 100 mcg intradermal patch, given once weekly for 2 weeks

Treatment:

Drug: D-MNA 100 mcg

microneedle array patch alone

Experimental group

Description:

P-MNA, intradermal patch, given once weekly for 2 weeks

Treatment:

Other: microneedle array alone