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

Phase 2

Recruiting

• Conditions: Nodular Basal Cell Carcinoma
• Interventions: Drug: D-MNA 200 mcg; Drug: D-MNA 100 mcg; Other: Placebo

• Registration Number: NCT06608238
• Lead Sponsor: SkinJect, Inc.

Brief 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.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-03
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Primary Completion: 2025-02-05
• Study Completion: 2025-06-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 .

9. Used topical immunomodulators within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.

10. 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.

11. 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.

12. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	D-MNA 200 mcg	D-MNA 200 mcg, intradermal patch, given once weekly for 2 weeks.
Arm B	D-MNA 100 mcg	D-MNA 100 mcg intradermal patch, given once weekly for 2 weeks
Arm C	Placebo	P-MNA, intradermal patch, given once weekly for 2 weeks

Primary Outcome Measures

Name	Time	Method
Histological Clearance of Target Lesion	29 to 34 days from enrollment into the study	Proportion of subjects with complete histological clearance of the Target Lesion at Visit 5/EV

Secondary Outcome Measures

Name	Time	Method
Clinical Clearance of Target Lesion	29 to 34 days from enrollment into the study	Proportion of subjects with complete clinical clearance of the Target Lesion at Visit 5/EV.

Trial Locations

Locations (6)

Site #4; 🇺🇸 Fresno, California, United States

Site #6; 🇺🇸 San Diego, California, United States

Site #3; 🇺🇸 Highlands, New Jersey, United States

Site #1; 🇺🇸 Rolling Meadows, Illinois, United States

Site#2; 🇺🇸 Knoxville, Tennessee, United States

Site #5; 🇺🇸 Mandeville, Louisiana, United States