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

NCT ID: NCT04928222

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-24
• Study Completion Date: 2024-06-30

Brief 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 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).

Conditions

Basal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Doxorubicin-containing MNA - 100 µg

A doxorubicin-containing array of 100 µg will be applied to subjects.

Group Type: ACTIVE_COMPARATOR

Doxorubicin-containing MNA

Intervention Type: COMBINATION_PRODUCT

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

Placebo MNA for Training

Training phase for application of arrays

Group Type: EXPERIMENTAL

Placebo-containing MNA

Intervention Type: DRUG

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

Interventions

Doxorubicin-containing MNA

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

Intervention Type: COMBINATION_PRODUCT

Placebo-containing MNA

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adult males and females, 18+ years in general good health as assessed by the investigator.

2. Clinical laboratory results within the following ranges:

1. granulocytes ≥2,000/mm3

2. platelets >50,000/mm3

3. serum creatinine ≤2X the upper limit of normal (ULN)

4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), alkaline phosphatase ≤3X the ULN.

3. 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.

4. Subject must be willing to adhere to the instructions of the investigator and his or her research team.

5. Subject must sign an Informed Consent Form prior to any study specific procedures and entry into the study.

6. 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.

7. Biopsy removed ≤25% of the original volume of the target lesion.

8. Primary BCC (i.e., no previous treatment)

9. 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

10. Subjects must avoid sunlight/ultraviolet light to the target lesion for the duration of the study.

11. Female subjects must be:

1. postmenopausal (no menstrual period for a minimum of 12 months), or

2. surgically sterile upon entry into the study.

3. 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

12. 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

1. Evidence of clinically significant, unstable medical conditions as assessed by the investigator.

2. Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.

3. Female subjects who are pregnant or breastfeeding.

4. The subject has uncontrolled, significant intercurrent or recent illness.

5. 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.

6. Topical therapy(ies) to the target lesion within 6 weeks of first treatment.

7. Prior excisional surgery performed on the lesion to be treated in this study.

8. Recent therapy(ies) to the BCC treatment area.

9. Recurrent BCC (previously treated) at the site presented for treatment.

10. BCC lesion to be treated is located in an area where excisional biopsy is undesired or aesthetically unacceptable to the subject

11. 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.

12. Subject with evidence of metastatic malignancies.

13. Concomitant disease requiring systemic immunosuppressive treatment.

14. Genetic skin cancer disorder, e.g., basal cell nevus syndrome.

15. 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).

16. 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.

17. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SkinJect, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan M Buttler

Role: STUDY_DIRECTOR

SkinJect, Inc.

Locations

Beer Dermatology

West Palm Beach, Florida, United States

New York and Presbyterian Hospital

New York, New York, United States

Countries

United States

Other Identifiers

SKNJCT-002

Identifier Type: -

Identifier Source: org_study_id