Open-Label Dose Escalation Trial to Evaluate Dose Limiting Toxicity and Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in BCC
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03646188 |
Recruitment Status :
Completed
First Posted : August 24, 2018
Last Update Posted : May 13, 2021
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Basal Cell Carcinoma | Drug: Placebo-containing MNA Drug: 25 µg doxorubicin-containing MNA Drug: 50 µg doxorubicin-containing MNA Drug: 100 µg doxorubicin-containing MNA Drug: 200 µg doxorubicin-containing MNA | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | 3+3 Design |
Masking: | None (Open Label) |
Masking Description: | Placebo |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | June 10, 2020 |
Actual Primary Completion Date : | March 1, 2021 |
Actual Study Completion Date : | May 4, 2021 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo-containing MNA
Placebo
|
Drug: Placebo-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.
Other Name: Placebo |
Experimental: 25 µg Doxorubicin-containing MNA
D-MNA's containing 25 µg of doxorubicin hydrochloride
|
Drug: 25 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.
Other Name: 25 µg D-MNA |
Experimental: 50 µg Doxorubicin-containing MNA
D-MNA's containing 50 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.
Other Name: 50 µg D-MNA |
Experimental: 100 µg Doxorubicin-containing MNA
D-MNA's containing 100 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.
Other Name: 100 µg D-MNA |
Experimental: 200 µg Doxorubicin-containing MNA
D-MNA's containing 200 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.
Other Name: 200 µg D-MNA |
- Dose limiting toxicity (DLT) and maximum tolerated dose (MTD) [ Time Frame: 4 weeks ]Presence or absence of cutaneous reactions to the D-MNA application
- Efficacy as measured by histological analysis [ Time Frame: 4 weeks ]Histological confirmation of basal cell carcinoma eradication

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646188
United States, Florida | |
The Center for Clinical and Cosmetic Research | |
Aventura, Florida, United States, 33180 |
Study Director: | Gregory Suplick | InClinica, Inc. |
Responsible Party: | SkinJect, Inc. |
ClinicalTrials.gov Identifier: | NCT03646188 |
Other Study ID Numbers: |
SKNJCT-001 |
First Posted: | August 24, 2018 Key Record Dates |
Last Update Posted: | May 13, 2021 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Basal Cell Doxorubicin |
Liposomal doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |