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

Last updated: September 19, 2024
Sponsor: SkinJect, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Basal Cell Carcinoma

Carcinoma

Treatment

D-MNA 100 mcg

Placebo

D-MNA 200 mcg

Clinical Study ID

NCT06608238
SKNJCT-003
  • Ages 18-85
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or non-pregnant female ≥ 18 years of age.

  2. Clinical diagnosis of a primary, previously untreated, histologically confirmednodular Basal Cell Carcinoma (nBCC) lesion suitable for excision (at end of thestudy) with a minimum diameter of 0.5 cm and with a maximum longest diameter of 1.3cm at the time of biopsy and Visit 2/Baseline.

  3. Willing to refrain from exposure to excessive direct sunlight or ultraviolet lightand 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 studyinstructions, and commit to all follow-up visits for the duration of the study.

Exclusion

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 orpreviously 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 basalor 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) serumcreatinine greater than 2 times the upper limit of normal (ULN), (d) aspartateaminotransferase, alkaline aminotransferase, lactate dehydrogenase, or alkalinephosphatase 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 weeksprior to Visit 2/Baseline or after the confirmatory biopsy.

  10. Used the following topical agents within 2 cm of the Target Lesion within the 4weeks prior to Visit 2/Baseline or after the confirmatory biopsy: aminolevulinicacid, 5-fluorouracil, diclofenac, ingenol mebutate, tirbanibulin, or imiquimod.

  11. Has been treated with liquid nitrogen, surgical excision or curettage within 2 cm ofthe Target Lesion within 4 weeks prior to Visit 2/Baseline or after the confirmatorybiopsy.

  12. Currently enrolled in an investigational drug, biologic, or device study. 12. Usedan investigational drug, investigational biologic, or investigational devicetreatment within 30 days prior to enrollment into the study.

  13. Unlikely to comply with the requirements of the study protocol (e.g., due toalcoholism, drug dependency, mental incapacity)

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: D-MNA 100 mcg
Phase: 2
Study Start date:
September 03, 2024
Estimated Completion Date:
June 02, 2025

Study 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.

Connect with a study center

  • Site #4

    Fresno, California 93720
    United States

    Active - Recruiting

  • Site #6

    San Diego, California 92108
    United States

    Site Not Available

  • Site #1

    Rolling Meadows, Illinois 60008
    United States

    Active - Recruiting

  • Site #5

    Mandeville, Louisiana 70448
    United States

    Active - Recruiting

  • Site #3

    Highlands, New Jersey 07716
    United States

    Active - Recruiting

  • Site#2

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

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