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TERMINATED
NCT03646188
PHASE1

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

Sponsor: SkinJect, Inc.

View on ClinicalTrials.gov

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).

Official title: An Open-Label Dose Escalation Trial to Evaluate Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Safety, and Tolerability of Microneedle Arrays Containing Doxorubicin (D-MNA) in Participants With Basal Cell Carcinoma (BCC)

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2020-06-10

Completion Date

2021-05-04

Last Updated

2026-04-16

Healthy Volunteers

No

Interventions

DRUG

Placebo-containing MNA

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

DRUG

25 µg doxorubicin-containing MNA

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

DRUG

50 µg doxorubicin-containing MNA

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

DRUG

100 µg doxorubicin-containing MNA

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

DRUG

200 µg doxorubicin-containing MNA

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

Locations (1)

The Center for Clinical and Cosmetic Research

Aventura, Florida, United States