NCT03646188

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

Terminated Phase 1 Results posted Last updated 16 April 2026

What this trial tests

Phase 1 trial testing Placebo-containing MNA in Basal Cell Carcinoma in 13 participants. Terminated before completion.

Timeline

10 June 2020

Primary endpoint
1 March 2021

4 May 2021

Quick facts

Lead sponsor	SkinJect, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	10 June 2020
Primary completion	1 March 2021
Estimated completion	4 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Placebo-containing MNA — full drug profile →
• 25 µg doxorubicin-containing MNA — full drug profile →
• 50 µg doxorubicin-containing MNA — full drug profile →
• 100 µg doxorubicin-containing MNA — full drug profile →
• 200 µg doxorubicin-containing MNA — full drug profile →

Conditions studied

• Basal Cell Carcinoma — all drugs for Basal Cell Carcinoma →

Sponsor

SkinJect, Inc. — full company profile →

Who can join

40 and older, any sex, with Basal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale Primary · 4 weeks

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

Participants

Group	Value	95% CI
Placebo-containing MNA	3
25 µg Doxorubicin-containing MNA	3
50 µg Doxorubicin-containing MNA	3
100 µg Doxorubicin-containing MNA	3
200 µg Doxorubicin-containing MNA	1

Participants with DLTs

Group	Value	95% CI
Placebo-containing MNA	0
25 µg Doxorubicin-containing MNA	0
50 µg Doxorubicin-containing MNA	0
100 µg Doxorubicin-containing MNA	0
200 µg Doxorubicin-containing MNA	0

Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis Secondary · 4 weeks

Complete Response (CR), defined as histological confirmation by central reading of basal cell carcinoma excision in all study participants

Group	Value	95% CI
Placebo-containing MNA	1
25 µg Doxorubicin-containing MNA	2
50 µg Doxorubicin-containing MNA	1
100 µg Doxorubicin-containing MNA	1
200 µg Doxorubicin-containing MNA	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 50 days. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo-containing MNA

Serious: 0/3 (0%)

Deaths: 0/3

25 µg Doxorubicin-containing MNA

Serious: 0/3 (0%)

Deaths: 0/3

50 µg Doxorubicin-containing MNA

Serious: 0/3 (0%)

Deaths: 0/3

100 µg Doxorubicin-containing MNA

Serious: 0/3 (0%)

Deaths: 0/3

200 µg Doxorubicin-containing MNA

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (1 terms — click to expand)

Reaction	System	Placebo-containing MNA	25 µg Doxorubicin-containi…	50 µg Doxorubicin-containi…	100 µg Doxorubicin-contain…	200 µg Doxorubicin-contain…
Application site pain	Skin and subcutaneous tissue disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT03646188 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microneedle Array: Applications, Recent Advances, and Clinical Pertinence in Transdermal Drug Delivery.
   Halder J, Gupta S, Kumari R, Gupta GD, et al · · 2021 · cited 63× · PMID 32837607 · DOI 10.1007/s12247-020-09460-2
2. Revolutionizing Therapeutic Delivery with Microneedle Technology for Tumor Treatment.
   Desai VM, Priya S, Gorantla S, Singhvi G. · · 2022 · cited 19× · PMID 36678643 · DOI 10.3390/pharmaceutics15010014
3. Microneedles as a Promising Technology for Disease Monitoring and Drug Delivery: A Review.
   Hulimane Shivaswamy R, Binulal P, Benoy A, Lakshmiramanan K, et al · · 2025 · cited 15× · PMID 39802146 · DOI 10.1021/acsmaterialsau.4c00125
4. From mechanism to applications: Advanced microneedles for clinical medicine.
   Yang Y, Sun H, Sun X, Wang Y, et al · · 2025 · cited 9× · PMID 40463395 · DOI 10.1016/j.bioactmat.2025.04.025
5. Recent progress of polymeric microneedle-assisted long-acting transdermal drug delivery.
   Meng F, Qiao X, Xin C, Ju X, et al · · 2024 · cited 8× · PMID 38571937 · DOI 10.3389/jpps.2024.12434
6. A microarray patch SARS-CoV-2 vaccine induces sustained antibody responses and polyfunctional cellular immunity.
   Balmert SC, Ghozloujeh ZG, Carey CD, Williams LH, et al · · 2022 · cited 8× · PMID 36062075 · DOI 10.1016/j.isci.2022.105045
7. Advances in microneedle-based drug delivery system for metabolic diseases: structural considerations, design strategies, and future perspectives.
   Li Y, Chen Q, Wang T, Ji Z, et al · · 2025 · cited 7× · PMID 40380261 · DOI 10.1186/s12951-025-03432-9
8. Barrier-disrupting microneedle technology: Overcoming physical, physiological, and pathological skin defenses to enhance therapeutic efficacy.
   Jiang Z, Wu W, Chen T, Hu W, et al · · 2026 · cited 2× · PMID 41334375 · DOI 10.1016/j.bioactmat.2025.11.005