Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)

NCT03646188 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: SKNJCT-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I study in participants with superficial or nodular Basal Cell Carcinoma (BCC), designed to assess dose limiting toxicities and maximum tolerated dose, efficacy, safety, and tolerability of dissolvable, tip-loaded, microneedle arrays containing doxorubicin (D-MNA).

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale

  Dose Limiting Toxicity (DLT) in Trial Subjects Assessed by Local Skin Response Grading Scale, 0-4, 4 being the worst dermal response

  4 weeks

Secondary Outcomes (1)

• Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis

  4 weeks

Study Arms (5)

Placebo-containing MNA

PLACEBO COMPARATOR

Placebo

Drug: Placebo-containing MNA

25 µg Doxorubicin-containing MNA

EXPERIMENTAL

D-MNA's containing 25 µg of doxorubicin hydrochloride

Drug: 25 µg doxorubicin-containing MNA

50 µg Doxorubicin-containing MNA

EXPERIMENTAL

D-MNA's containing 50 µg of doxorubicin hydrochloride

Drug: 50 µg doxorubicin-containing MNA

100 µg Doxorubicin-containing MNA

EXPERIMENTAL

D-MNA's containing 100 µg of doxorubicin hydrochloride

Drug: 100 µg doxorubicin-containing MNA

200 µg Doxorubicin-containing MNA

EXPERIMENTAL

D-MNA's containing 200 µg of doxorubicin hydrochloride

Drug: 200 µg doxorubicin-containing MNA

Interventions

25 µg doxorubicin-containing MNA DRUG

A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.

Also known as: 25 µg D-MNA

25 µg Doxorubicin-containing MNA

50 µg doxorubicin-containing MNA DRUG

A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.

Also known as: 50 µg D-MNA

50 µg Doxorubicin-containing MNA

100 µg doxorubicin-containing MNA DRUG

A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.

Also known as: 100 µg D-MNA

100 µg Doxorubicin-containing MNA

200 µg doxorubicin-containing MNA DRUG

A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.

Also known as: 200 µg D-MNA

200 µg Doxorubicin-containing MNA

Placebo-containing MNA DRUG

A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.

Also known as: Placebo

Placebo-containing MNA

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females, 40+ years in general good health as assessed by the investigator.
• BCC (subtype: superficial or nodular) confirmed histologically by diagnostic shave biopsy at the Screening Visit
• Primary BCC (i.e., no previous treatment)
• Lesion size ≥ 4 mm2 or 2 x 2 mm and ≤ 169 mm2 or 13 x 13 mm
• Participant 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
• Negative urine pregnancy at study entry for female of child bearing potential
• Men and women of child-producing potential must agree to use adequate contraception according to standard instructions by the investigator until the completion of the study
• Participant must to be willing to adhere to the instructions of the investigator and his or her research team
• Participant must sign an Informed Consent Form prior to any study specific procedures and entry into the study

You may not qualify if:

• Evidence of clinically significant, unstable medical conditions as assessed by the investigator
• Excisional biopsy 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 participant
• Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.
• Participant with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix
• Concomitant disease requiring systemic immunosuppressive treatment
• Genetic skin cancer disorder, e.g., basal cell nevus syndrome
• Participant is pregnant or breastfeeding
• Treatment with another investigational drug, device, or other intervention within 3 months prior to the Screening Visit
• Existing condition or treatment within 3 months prior to the Screening Visit that may have impact on clinical outcome for the treatment of BCC or delay in wound healing from the elliptical excision

Sponsors & Collaborators

• SkinJect, Inc.: lead

Study Sites (1)

The Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Edward Brennan, MD., Chief Scientific Officer
• Organization: Medicus Pharma

hqamar@medicuspharma.com

484-680-1844

Study Officials

• Gregory Suplick

  InClinica, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Placebo
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 Design

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: June 10, 2020
• Primary Completion: March 1, 2021
• Study Completion: May 4, 2021
• Last Updated: April 16, 2026
• Results First Posted: August 17, 2022

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)