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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxorubicin-containing MNA - 100 µg | Active Comparator | A doxorubicin-containing array of 100 µg will be applied to subjects. |
|
| Placebo MNA for Training | Experimental | Training phase for application of arrays |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxorubicin-containing MNA | Combination Product | A 15 x 15 millimeter array containing 400 dissolvable microneedles delivering active agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Eradication of Basal Cell Cancer based on Histologic Analysis | Tissue will be excised and sectioned for histologic analysis | Up to 4 weeks after the last array application to a subject |
| Number of subjects with dose-limiting toxicity and treatment-related adverse events by CTCAE v4.0 | Determination of cutaneous tolerability of arrays after application | Assessment at week 2 of subject visit |
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Inclusion Criteria:
Adult males and females, 18+ years in general good health as assessed by the investigator.
Clinical laboratory results within the following ranges:
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:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan M Buttler | SkinJect, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beer Dermatology | West Palm Beach | Florida | 33411 | United States | ||
| New York and Presbyterian Hospital |
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Investigational product will have randomly generated product code on label.
| Placebo-containing MNA | Drug | A 15 15 x 15 millimeter array containing 400 dissolvable microneedles containing placebo |
|
| New York |
| New York |
| 10032 |
| United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 31, 2024 | Jun 26, 2024 | 9 |
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D018295 | Neoplasms, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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