Basal Cell CarcinomaPhase 1NCT03646188
Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)
A Phase 1 study testing 25 µg doxorubicin-containing MNA, 50 µg doxorubicin-containing MNA and 100 µg doxorubicin-containing MNA in people with Basal Cell Carcinoma, run by SkinJect, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- 25 µg doxorubicin-containing MNA, 50 µg doxorubicin-containing MNA and 100 µg doxorubicin-containing MNA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2020to 4 May 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
About this study
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)
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).
Read the detailed 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). Doxorubicin is a cytotoxic anthracycline antibiotic and is currently approved for the treatment of a broad range of cancers, including but not limited to: breast, bladder, gastric, and ovarian cancers; small cell lung cancer; acute lymphoblastic leukemia; and acute myelo blastic leukemia. SkinJect, Inc. has developed a novel delivery system in the form of a tip-loaded dissolvable microneedle array (MNA) which will allow for topical delivery of doxorubicin directly to the lesion at concentrations that are far below standard systemic dosing, thereby reducing the adverse events associated with systemic delivery. The primary objective of this investigation is to establish the highest safe and tolerable dose of single applications of D-MNA, one application per week for three weeks in placebo, 25 µg, 50 µg, 100 µg, and 200 µg dose groups in participants with BCC.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Placebo-containing MNA, 25 µg doxorubicin-containing MNA, 50 µg doxorubicin-containing MNA, 100 µg doxorubicin-containing MNA, 200 µg doxorubicin-containing MNA
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo-containing MNADrug
Also called Placebo
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.
25 µg doxorubicin-containing MNADrug
Also called 25 µg D-MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.
50 µg doxorubicin-containing MNADrug
Also called 50 µg D-MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.
100 µg doxorubicin-containing MNADrug
Also called 100 µg D-MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.
200 µg doxorubicin-containing MNADrug
Also called 200 µg D-MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.
| Study group | Role | What they receive |
|---|---|---|
| Placebo-containing MNA | Placebo comparator | Placebo Receives: Drug: Placebo-containing MNA |
| 25 µg Doxorubicin-containing MNA | Experimental | D-MNA's containing 25 µg of doxorubicin hydrochloride Receives: Drug: 25 µg doxorubicin-containing MNA |
| 50 µg Doxorubicin-containing MNA | Experimental | D-MNA's containing 50 µg of doxorubicin hydrochloride Receives: Drug: 50 µg doxorubicin-containing MNA |
| 100 µg Doxorubicin-containing MNA | Experimental | D-MNA's containing 100 µg of doxorubicin hydrochloride Receives: Drug: 100 µg doxorubicin-containing MNA |
| 200 µg Doxorubicin-containing MNA | Experimental | D-MNA's containing 200 µg of doxorubicin hydrochloride Receives: Drug: 200 µg doxorubicin-containing MNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (1)
Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis
Complete Response (CR), defined as histological confirmation by central reading of basal cell carcinoma excision in all study participants
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start10 Jun 2020
- Primary completion1 Mar 2021
- Study completion4 May 2021
Why it stopped: Application of arrays was inconsistent.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3+3 Design
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- SkinJect, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Suplick, Study director, InClinica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646188
- Sponsor's protocol ID
- SKNJCT-001
- Status last verified
- Mar 2026
- First submitted
- 22 Aug 2018
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03646188
- Acronym / sponsor ID
- SKNJCT-001
- Conditions
- Basal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Application of arrays was inconsistent.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- SkinJect, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 17 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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). Doxorubicin is a cytotoxic anthracycline antibiotic and is currently approved for the treatment of a broad range of cancers, including but not limited to: breast, bladder, gastric, and ovarian cancers; small cell lung cancer; acute lymphoblastic leukemia; and acute myelo blastic leukemia. SkinJect, Inc. has developed a novel delivery system in the form of a tip-loaded dissolvable microneedle array (MNA) which will allow for topical delivery of doxorubicin directly to the lesion at concentrations that are far below standard systemic dosing, thereby reducing the adverse events associated with systemic delivery. The primary objective of this investigation is to establish the highest safe and tolerable dose of single applications of D-MNA, one application per week for three weeks in placebo, 25 µg, 50 µg, 100 µg, and 200 µg dose groups in participants with BCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 3+3 Design
| Arm | Type | Receives |
|---|---|---|
| Placebo-containing MNA | Placebo comparator | Drug: Placebo-containing MNAPlacebo |
| 25 µg Doxorubicin-containing MNA | Experimental | Drug: 25 µg doxorubicin-containing MNAD-MNA's containing 25 µg of doxorubicin hydrochloride |
| 50 µg Doxorubicin-containing MNA | Experimental | Drug: 50 µg doxorubicin-containing MNAD-MNA's containing 50 µg of doxorubicin hydrochloride |
| 100 µg Doxorubicin-containing MNA | Experimental | Drug: 100 µg doxorubicin-containing MNAD-MNA's containing 100 µg of doxorubicin hydrochloride |
| 200 µg Doxorubicin-containing MNA | Experimental | Drug: 200 µg doxorubicin-containing MNAD-MNA's containing 200 µg of doxorubicin hydrochloride |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo-containing MNAAlso: PlaceboA 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo. | Drug | Placebo-containing MNA |
| 25 µg doxorubicin-containing MNAAlso: 25 µg D-MNAA 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride. | Drug | 25 µg Doxorubicin-containing MNA |
| 50 µg doxorubicin-containing MNAAlso: 50 µg D-MNAA 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride. | Drug | 50 µg Doxorubicin-containing MNA |
| 100 µg doxorubicin-containing MNAAlso: 100 µg D-MNAA 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride. | Drug | 100 µg Doxorubicin-containing MNA |
| 200 µg doxorubicin-containing MNAAlso: 200 µg D-MNAA 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride. | Drug | 200 µg Doxorubicin-containing MNA |
Primary outcome
Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale
Time frame: 4 weeks
Dose Limiting Toxicity (DLT) in Trial Subjects Assessed by Local Skin Response Grading Scale, 0-4, 4 being the worst dermal response
1 secondary outcome
Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Basal Cell Carcinoma
Not yet recruiting
Plasmonic PhotoThermal Therapy (PPTT) With Glucose-Coated Gold Nanoparticles (TSK-001) in Patients With Nodular Basal Cell Carcinoma (nBCC)
Nodular BCC
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
RecruitingObservational study
Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice
Basal Cell Carcinoma of Skin, Optical Coherence Tomography (OCT)
Active, not recruitingPhase 2
Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Suplick study director
InClinica, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 25 µg doxorubicin-containing MNA, 50 µg doxorubicin-containing MNA and 100 µg doxorubicin-containing MNA in people with Basal Cell Carcinoma, run by SkinJect, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.