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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Basal Cell Carcinoma

In brief

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).

Key facts

Study ID

NCT03646188

Run by

SkinJect, Inc.

People needed

13

Starts

2020-06-10

Expected to finish

2021-05-04

Last updated by the study team

2026-04-16

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• The Center for Clinical and Cosmetic Research — Aventura, Florida, United States

Full record on ClinicalTrials.gov

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