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Basal Cell CarcinomaPhase 1/2NCT04928222

Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)

A Phase 1/2 study testing Doxorubicin-containing MNA in people with Basal Cell Carcinoma, run by SkinJect, Inc. at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Part I is designed as a study of P-MNA application in healthy human volunteers. The goal of Part I is to determine several factors possibly affecting the rate and extent of microneedle array dissolution, such as anatomic location; age; duration of array exposure to the skin; and the criticality of proper array… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Basal Cell Carcinoma
What is being tested?
Doxorubicin-containing MNA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
2 sitesUnited States
Study dates
24 Sep 2021to 30 Jun 2024
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult males and females, 18+ years in general good health as assessed by the investigator.
  • Clinical laboratory results within the following ranges:
  • granulocytes ≥2,000/mm3
  • platelets >50,000/mm3
  • serum creatinine ≤2X the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), alkaline phosphatase ≤3X the ULN.
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  • Subject 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.
  • Subject must be willing to adhere to the instructions of the investigator and his or her research team.
  • Subject must sign an Informed Consent Form prior to any study specific procedures and entry into the study.
  • BCC (subtype: superficial or nodular) confirmed histologically by diagnostic shave biopsy at the Screening Visit. If previously confirmed, subjects can only have diagnosed BCC via shaved biopsy within 6 months of first study treatment.
  • Biopsy removed ≤25% of the original volume of the target lesion.
  • Primary BCC (i.e., no previous treatment)
  • Lesion size ≥ 64 mm2 or 8 x 8 mm and ≤ 169 mm2 or 13 x 13 mm, i.e., the entire lesion must be covered by 13X13 mm area of the array containing the microneedles
  • Subjects must avoid sunlight/ultraviolet light to the target lesion for the duration of the study.
  • Female subjects must be:
  • postmenopausal (no menstrual period for a minimum of 12 months), or
  • surgically sterile upon entry into the study.
  • female subjects of childbearing potential must have a negative pregnancy test upon entry into this study and agree to use a highly effective method of contraception from Screening until the final follow-up visit. Consult Section 5.5 in this protocol for a description of effective contraceptive methods. Female subjects must also have negative pregnancy tests before each dose is applied to female subjects
  • Male subjects with female partners of child bearing potential must be either surgically sterile or agree to use a double-barrier contraception method (i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam) from screening until the final follow-up visit.

Who cannot join

  • Evidence of clinically significant, unstable medical conditions as assessed by the investigator.
  • Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.
  • Female subjects who are pregnant or breastfeeding.
  • The subject has uncontrolled, significant intercurrent or recent illness.
  • Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g. dabigatran), betrixaban, or platelet inhibitors (eg, clopidogrel). Prophylactic use of Low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH) are permitted.
  • Topical therapy(ies) to the target lesion within 6 weeks of first treatment.
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  • Prior excisional surgery 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 subject
  • Subject with other active malignancies except for non-metastatic prostate cancer, carcinoma in situ of the skin or cervix, and basal cell cancer in locations other than lesion of interest.
  • Subject with evidence of metastatic malignancies.
  • Concomitant disease requiring systemic immunosuppressive treatment.
  • Genetic skin cancer disorder, e.g., basal cell nevus syndrome.
  • Subject is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment (patients who are in a follow-up phase of an investigational study may participate as long as it has been 30 days after the last dose of the previous investigational agent).
  • Evidence of dermatological disease or confounding skin condition within 3 mm margin of the target BCC lesion, e.g., SCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema.
  • 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 standard of care excision.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • New York and Presbyterian Hospital

    New York, New York, 10032

  • Beer Dermatology

    West Palm Beach, Florida, 33411

Other trials in United States

About this study

Official title: A Trial to Evaluate Placebo Microneedle Arrays in Healthy Human Volunteers (Part I), Followed by Proof of Concept Testing of Efficacy and Safety of Doxorubicin Microneedle Arrays in Subjects With Basal Cell Cancer (Part II)

Part I is designed as a study of P-MNA application in healthy human volunteers. The goal of Part I is to determine several factors possibly affecting the rate and extent of microneedle array dissolution, such as anatomic location; age; duration of array exposure to the skin; and the criticality of proper array application to the skin. Part II will be a randomized study in which doxorubicin-containing arrays will be applied to subjects demonstrated by biopsy to have basal cell cancer. A subject will be randomized to one of four dose groups: placebo microneedle array and 50 µg, 100 µg, and 200 µg doses of doxorubicin in a tip-loaded, dissolvable microneedle arrays (D-MNA).

Being tested
Doxorubicin-containing MNA, Placebo-containing MNA
Keywords
Basal cell cancer
Medical subject headings
Carcinoma, Basal Cell, Neoplasms, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doxorubicin-containing MNACombination product

    A 15 x 15 millimeter array containing 400 dissolvable microneedles delivering active agent

  • Placebo-containing MNADrug

    A 15 15 x 15 millimeter array containing 400 dissolvable microneedles containing placebo

Study groups in NCT04928222
Study groupRoleWhat they receive
Doxorubicin-containing MNA - 100 µgActive comparatorA doxorubicin-containing array of 100 µg will be applied to subjects.
Receives: Combination Product: Doxorubicin-containing MNA
Placebo MNA for TrainingExperimentalTraining phase for application of arrays
Receives: Drug: Placebo-containing MNA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with Eradication of Basal Cell Cancer based on Histologic Analysis

    Tissue will be excised and sectioned for histologic analysis

    Measured: Up to 4 weeks after the last array application to a subject

  2. Number of subjects with dose-limiting toxicity and treatment-related adverse events by CTCAE v4.0

    Determination of cutaneous tolerability of arrays after application

    Measured: Assessment at week 2 of subject visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2021
  2. Study start24 Sep 2021
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04928222
Sponsor's protocol ID
SKNJCT-002
Status last verified
Apr 2023
First submitted
3 Jun 2021
Last updated
14 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Doxorubicin-containing MNA in people with Basal Cell Carcinoma, run by SkinJect, Inc. at 2 sites 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 19 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

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?

This study is still under way. Results are not available in the source record yet.

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 subjects with Eradication of Basal Cell Cancer based on Histologic Analysis (time frame: Up to 4 weeks after the last array application to a subject). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04928222.

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 14 Apr 2023.

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