Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)

NCT04928222 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SKNJCT-002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

Part I is designed as a study of P-MNA application in healthy human volunteers. The goal of Part I is to determine several factors possibly affecting the rate and extent of microneedle array dissolution, such as anatomic location; age; duration of array exposure to the skin; and the criticality of proper array application to the skin. Part II will be a randomized study in which doxorubicin-containing arrays will be applied to subjects demonstrated by biopsy to have basal cell cancer. A subject will be randomized to one of four dose groups: placebo microneedle array and 50 µg, 100 µg, and 200 µg doses of doxorubicin in a tip-loaded, dissolvable microneedle arrays (D-MNA).

Conditions

Basal Cell Carcinoma

Keywords

Basal cell cancer

Outcome Measures

Primary Outcomes (2)

• Number of subjects with Eradication of Basal Cell Cancer based on Histologic Analysis

  Tissue will be excised and sectioned for histologic analysis

  Up to 4 weeks after the last array application to a subject

• Number of subjects with dose-limiting toxicity and treatment-related adverse events by CTCAE v4.0

  Determination of cutaneous tolerability of arrays after application

  Assessment at week 2 of subject visit

Study Arms (2)

Doxorubicin-containing MNA - 100 µg

ACTIVE COMPARATOR

A doxorubicin-containing array of 100 µg will be applied to subjects.

Combination Product: Doxorubicin-containing MNA

Placebo MNA for Training

EXPERIMENTAL

Training phase for application of arrays

Drug: Placebo-containing MNA

Interventions

Doxorubicin-containing MNA COMBINATION_PRODUCT

A 15 x 15 millimeter array containing 400 dissolvable microneedles delivering active agent

Doxorubicin-containing MNA - 100 µg

Placebo-containing MNA DRUG

A 15 15 x 15 millimeter array containing 400 dissolvable microneedles containing placebo

Placebo MNA for Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females, 18+ years in general good health as assessed by the investigator.
• Clinical laboratory results within the following ranges:
• granulocytes ≥2,000/mm3
• platelets \>50,000/mm3
• serum creatinine ≤2X the upper limit of normal (ULN)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), alkaline phosphatase ≤3X the ULN.
• Subject must have no other "clinically significant" abnormal findings in his/her medical history, physical examination or clinical laboratory test results as assessed by the investigator.
• Subject must be willing to adhere to the instructions of the investigator and his or her research team.
• Subject must sign an Informed Consent Form prior to any study specific procedures and entry into the study.
• BCC (subtype: superficial or nodular) confirmed histologically by diagnostic shave biopsy at the Screening Visit. If previously confirmed, subjects can only have diagnosed BCC via shaved biopsy within 6 months of first study treatment.
• Biopsy removed ≤25% of the original volume of the target lesion.
• Primary BCC (i.e., no previous treatment)
• Lesion size ≥ 64 mm2 or 8 x 8 mm and ≤ 169 mm2 or 13 x 13 mm, i.e., the entire lesion must be covered by 13X13 mm area of the array containing the microneedles
• Subjects must avoid sunlight/ultraviolet light to the target lesion for the duration of the study.
• Female subjects must be:

You may not qualify if:

• Evidence of clinically significant, unstable medical conditions as assessed by the investigator.
• Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.
• Female subjects who are pregnant or breastfeeding.
• The subject has uncontrolled, significant intercurrent or recent illness.
• Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g. dabigatran), betrixaban, or platelet inhibitors (eg, clopidogrel). Prophylactic use of Low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH) are permitted.
• Topical therapy(ies) to the target lesion within 6 weeks of first treatment.
• Prior excisional surgery performed on the lesion to be treated in this study.
• Recent therapy(ies) to the BCC treatment area.
• Recurrent BCC (previously treated) at the site presented for treatment.
• BCC lesion to be treated is located in an area where excisional biopsy is undesired or aesthetically unacceptable to the subject
• Subject with other active malignancies except for non-metastatic prostate cancer, carcinoma in situ of the skin or cervix, and basal cell cancer in locations other than lesion of interest.
• Subject with evidence of metastatic malignancies.
• Concomitant disease requiring systemic immunosuppressive treatment.
• Genetic skin cancer disorder, e.g., basal cell nevus syndrome.
• Subject is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment (patients who are in a follow-up phase of an investigational study may participate as long as it has been 30 days after the last dose of the previous investigational agent).

Sponsors & Collaborators

• SkinJect, Inc.: lead

Study Sites (2)

Beer Dermatology

West Palm Beach, Florida, 33411, United States

Location

New York and Presbyterian Hospital

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Neoplasms, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Susan M Buttler

  SkinJect, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigational product will have randomly generated product code on label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 16, 2021
• Study Start: September 24, 2021
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

US (2)