Nodular Basal Cell CarcinomaPhase 2NCT06608238
Phase 2 Study Evaluating the Safety and Efficacy of Microneedle-mediated Delivery of Doxorubicin (D-MNA) in Patients With Nodular Basal Cell Carcinoma.
A Phase 2 study testing D-MNA 200µg, D-MNA 100µg and Microneedle Array Alone in people with Nodular Basal Cell Carcinoma, run by SkinJect, Inc. at 11 sites in 2 countries.
Trial summary
This Phase 2 study evaluates the safety and efficacy of microneedle array (MNA) alone and in combination with two dose levels of doxorubicin (100µg and 200µg) in patients with nodular basal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nodular Basal Cell Carcinoma
- What is being tested?
- D-MNA 200µg, D-MNA 100µg and Microneedle Array Alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 3 Sep 2024to 13 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female ≥ 18 years of age at time of consent.
- Clinical diagnosis of a primary, previously untreated, histologically confirmed nodular Basal Cell Carcinoma (nBCC) lesion suitable for excision (at end of the study) with a minimum diameter of 0.5 cm and with a maximum longest diameter of 1.3 cm at the time of biopsy and Visit 2/Baseline.
Who cannot join
- Pregnant, lactating, or planning to become pregnant.
- nBCC is located on the face, scalp, digits, mucosa, or skin that is scarred or previously treated with radiation.
- History of treated nBCC lesion recurrence or basal cell nevus syndrome.
- Active malignancy, excluding non-metastatic prostate cancer, other cutaneous basal or squamous cell carcinomas, and carcinoma of the cervix.
- Used topical immunomodulators within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.
- Used the following topical agents within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy: aminolevulinic acid, 5-fluorouracil, diclofenac, ingenol mebutate, tirbanibulin, or imiquimod.
- Has been treated with liquid nitrogen, surgical excision or curettage within 2 cm of the Target Lesion within 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Rao Dermotology West Coast -Site #4
Fresno, California, 93720
HIckory Dermatology Research Center
Hickory, North Carolina, 28602
Rao Dermatology - Site #3
Highlands, New Jersey, 07716
American Skin and Cancer Center - Site#2
Knoxville, Tennessee, 37909
Clinical Trials Management, LLC- Site #5
Mandeville, Louisiana, 70448
Oak Dermotology - site 07
Naperville, Illinois, 60563
Virginia Clinical Research Inc - site 11
Norfolk, Virginia, 23502
Arlington Dermatology - Site #1
Rolling Meadows, Illinois, 60008
Paradigm Research -Site #6
San Diego, California, 92108
Therapeutics Clinical Research -site 08
San Diego, California, 92123
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, East Midlands, NG5 1PB
About this study
Official title: A Randomized, Double-blind, Three-arm Phase 2 Study Evaluating Two Dose Levels of Microneedle-mediated Delivery of Doxorubicin Compared With a Device-only Control in Patients With Nodular Basal Cell Carcinoma.
This Phase 2 study evaluates the safety and efficacy of microneedle array (MNA) alone and in combination with two dose levels of doxorubicin (100µg and 200µg) in patients with nodular basal cell carcinoma. Efficacy is assessed using both clinical (visual) and histological endpoints, which together provide a comprehensive evaluation of lesion response.
Read the detailed description
A total of 90 subjects were enrolled and randomized in a 1:1:1 ratio to receive microneedle array (MNA) alone or Doxorubicin-MNA (D-MNA) at dose levels of 100µg or 200µg. Treatments were administered once weekly for three applications to a single target lesion. Following treatment, the target lesion was excised at a prespecified timepoint and assessed for clearance. The study was amended during conduct to increase the total sample size (from 60 to 90) and to extend the timing of excision from Day 29 to Day 57 to allow for an optimized evaluation for treatment response. Efficacy is evaluated using both clinical (visual) and histological assessments. These endpoints represent complementary dimensions of lesion response, with clinical clearance reflecting visible resolution and histological clearance providing pathological confirmation. Central pathological review was conducted for all excision specimens and where possible, baseline biopsy visits to confirm nodular BCC. This Phase 2 study is exploratory in nature, and efficacy is interpreted based on the totality of evidence across endpoints rather than a strictly hierarchical framework. Analyses are descriptive and not powered for formal hypothesis testing.
- Conditions
- Nodular Basal Cell Carcinoma
- Being tested
- D-MNA 200µg, D-MNA 100µg, Microneedle Array Alone
- Keywords
- Doxorubicin, Microneedle Array, Basal Cell Carcinoma
- 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.
D-MNA 200µgDrug
D-MNA, (doxorubicin) patch, 200µg
D-MNA 100µgDrug
D-MNA (doxorubicin) patch, 100µg
Microneedle Array AloneOther
P-MNA patch, microneedle array alone
| Study group | Role | What they receive |
|---|---|---|
| 200µg patch | Active comparator | D-MNA 200µg, intradermal patch, given on day 1, day 8, and day 15. Receives: Drug: D-MNA 200µg |
| 100µg patch | Active comparator | D-MNA 100µg intradermal patch, given on day 1, day 8, and day 15. Receives: Drug: D-MNA 100µg |
| Device only (microneedle array alone) arm to assess mechanical and procedural effects. | Experimental | P-MNA, intradermal patch, given on day 1, day 8, and day 15. Receives: Other: Microneedle Array Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Clearance of Target Lesion
Proportion of subjects with complete histological clearance of the Target Lesion at Visit 5/EV. Histological clearance represents pathological confirmation of treatment response and is interpreted in the context of overall clinical and histological outcomes.
Measured: Day 29 or Day 57 following treatment, per protocol amendment.
Secondary outcomes (1)
Clinical Clearance of Target Lesion
Proportion of subjects achieving complete clinical (visual) clearance of the Target Lesion at Visit 5 / Excision Visit, reflecting visible resolution of disease following treatment.
Measured: Day 29 or Day 57 following treatment, per protocol amendment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start3 Sep 2024
- Primary completion5 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nodular 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 90 patients randomized in a 1:1:1 ratio to receive microneedle array (P-MNA) alone or D-MNA at dose levels of 100µg or 200µg.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- SkinJect, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608238
- Sponsor's protocol ID
- SKNJCT-003
- Status last verified
- Apr 2026
- First submitted
- 19 Sep 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Three-arm Phase 2 Study Evaluating Two Dose Levels of Microneedle-mediated Delivery of Doxorubicin Compared With a Device-only Control in Patients With Nodular Basal Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT06608238
- Acronym / sponsor ID
- SKNJCT-003
- Conditions
- Nodular Basal Cell Carcinoma
- Keywords
- Doxorubicin, Microneedle Array, Basal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- SkinJect, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 study evaluates the safety and efficacy of microneedle array (MNA) alone and in combination with two dose levels of doxorubicin (100µg and 200µg) in patients with nodular basal cell carcinoma. Efficacy is assessed using both clinical (visual) and histological endpoints, which together provide a comprehensive evaluation of lesion response.
Detailed description
A total of 90 subjects were enrolled and randomized in a 1:1:1 ratio to receive microneedle array (MNA) alone or Doxorubicin-MNA (D-MNA) at dose levels of 100µg or 200µg. Treatments were administered once weekly for three applications to a single target lesion. Following treatment, the target lesion was excised at a prespecified timepoint and assessed for clearance. The study was amended during conduct to increase the total sample size (from 60 to 90) and to extend the timing of excision from Day 29 to Day 57 to allow for an optimized evaluation for treatment response. Efficacy is evaluated using both clinical (visual) and histological assessments. These endpoints represent complementary dimensions of lesion response, with clinical clearance reflecting visible resolution and histological clearance providing pathological confirmation. Central pathological review was conducted for all excision specimens and where possible, baseline biopsy visits to confirm nodular BCC. This Phase 2 study is exploratory in nature, and efficacy is interpreted based on the totality of evidence across endpoints rather than a strictly hierarchical framework. Analyses are descriptive and not powered for formal hypothesis testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Approximately 90 patients randomized in a 1:1:1 ratio to receive microneedle array (P-MNA) alone or D-MNA at dose levels of 100µg or 200µg.
| Arm | Type | Receives |
|---|---|---|
| 200µg patch | Active comparator | Drug: D-MNA 200µgD-MNA 200µg, intradermal patch, given on day 1, day 8, and day 15. |
| 100µg patch | Active comparator | Drug: D-MNA 100µgD-MNA 100µg intradermal patch, given on day 1, day 8, and day 15. |
| Device only (microneedle array alone) arm to assess mechanical and procedural effects. | Experimental | Other: Microneedle Array AloneP-MNA, intradermal patch, given on day 1, day 8, and day 15. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or non-pregnant female ≥ 18 years of age at time of consent.
- Clinical diagnosis of a primary, previously untreated, histologically confirmed nodular Basal Cell Carcinoma (nBCC) lesion suitable for excision (at end of the study) with a minimum diameter of 0.5 cm and with a maximum longest diameter of 1.3 cm at the time of biopsy and Visit 2/Baseline.
Key exclusion criteria (7 listed)
- Pregnant, lactating, or planning to become pregnant.
- nBCC is located on the face, scalp, digits, mucosa, or skin that is scarred or previously treated with radiation.
- History of treated nBCC lesion recurrence or basal cell nevus syndrome.
- Active malignancy, excluding non-metastatic prostate cancer, other cutaneous basal or squamous cell carcinomas, and carcinoma of the cervix.
- Used topical immunomodulators within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.
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 |
|---|---|---|
| D-MNA 200µgD-MNA, (doxorubicin) patch, 200µg | Drug | 200µg patch |
| D-MNA 100µgD-MNA (doxorubicin) patch, 100µg | Drug | 100µg patch |
| Microneedle Array AloneP-MNA patch, microneedle array alone | Other | Device only (microneedle array alone) arm to assess mechanical and procedural effects. |
Primary outcome
Histological Clearance of Target Lesion
Time frame: Day 29 or Day 57 following treatment, per protocol amendment.
Proportion of subjects with complete histological clearance of the Target Lesion at Visit 5/EV. Histological clearance represents pathological confirmation of treatment response and is interpreted in the context of overall clinical and histological outcomes.
1 secondary outcome
Clinical Clearance of Target Lesion
Time frame: Day 29 or Day 57 following treatment, per protocol amendment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-MNA 200µg, D-MNA 100µg and Microneedle Array Alone in people with Nodular Basal Cell Carcinoma, run by SkinJect, Inc. at 11 sites in 2 countries.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, United Kingdom. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Histological Clearance of Target Lesion (time frame: Day 29 or Day 57 following treatment, per protocol amendment.). 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 4 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.