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History of Changes for Study: NCT03646188
Open-Label Dose Escalation Trial to Evaluate Dose Limiting Toxicity and Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma
Latest version (submitted August 16, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 22, 2018 None (earliest Version on record)
2 August 5, 2019 Study Status, Arms and Interventions and Study Design
3 September 17, 2019 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 January 8, 2020 Recruitment Status, Contacts/Locations, Study Status, Sponsor/Collaborators, IPDSharing and Study Identification
5 January 9, 2020 Contacts/Locations, Sponsor/Collaborators and Study Status
6 March 16, 2020 Study Status
7 June 11, 2020 Recruitment Status, Study Status and Contacts/Locations
8 February 16, 2021 Study Status
9 May 11, 2021 Recruitment Status, Study Status, Contacts/Locations, Study Design
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Results Submission Events
10 March 30, 2022 Recruitment Status, Study Status, Outcome Measures, Study Description, Document Section, Results and Study Identification
11 August 16, 2022 Outcome Measures and Study Status
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Study NCT03646188
Submitted Date:  August 22, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: SKNJCT-001
Brief Title: Open-Label Dose Escalation Trial to Evaluate Dose Limiting Toxicity and Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2018
Overall Status: Not yet recruiting
Study Start: October 15, 2018
Primary Completion: February 15, 2019 [Anticipated]
Study Completion: March 15, 2019 [Anticipated]
First Submitted: August 22, 2018
First Submitted that
Met QC Criteria:
August 22, 2018
First Posted: August 24, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
August 22, 2018
Last Update Posted: August 24, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: SkinJect, Inc.
Responsible Party: Sponsor
Collaborators: University of Colorado, Denver
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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). 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.
Detailed Description:
Open or close this module Conditions
Conditions: Basal Cell Carcinoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
3+3 Design
Number of Arms: 5
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo-containing MNA
Color-matched placebo
Drug: Placebo-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a color-matched placebo.
Other Names:
  • Placebo
Experimental: 25 µg Doxorubicin-containing MNA
D-MNA's containing 25 µg of doxorubicin hydrochloride
Drug: 25 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.
Other Names:
  • 25 µg D-MNA
Experimental: 50 µg Doxorubicin-containing MNA
D-MNA's containing 50 µg of doxorubicin hydrochloride
Drug: 50 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.
Other Names:
  • 50 µg D-MNA
Experimental: 100 µg Doxorubicin-containing MNA
D-MNA's containing 100 µg of doxorubicin hydrochloride
Drug: 100 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.
Other Names:
  • 100 µg D-MNA
Experimental: 200 µg Doxorubicin-containing MNA
D-MNA's containing 200 µg of doxorubicin hydrochloride
Drug: 200 µg doxorubicin-containing MNA
A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.
Other Names:
  • 200 µg D-MNA
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Dose limiting toxicity (DLT) and maximum tolerated dose (MTD)
[ Time Frame: 4 weeks ]

Presence or absence of cutaneous reactions to the D-MNA application
Secondary Outcome Measures:
1. Efficacy as measured by histological analysis
[ Time Frame: 4 weeks ]

Histological confirmation of basal cell carcinoma eradication
Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Adult males and females, 40+ years in general good health as assessed by the investigator.
  2. BCC (subtype: superficial or nodular) confirmed histologically by diagnostic shave biopsy at the Screening Visit
  3. Primary BCC (i.e., no previous treatment)
  4. Lesion size ≥ 4 mm2 or 2 x 2 mm and ≤ 169 mm2 or 13 x 13 mm
  5. 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
  6. Negative urine pregnancy at study entry for female of child bearing potential
  7. 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
  8. Participant must to be willing to adhere to the instructions of the investigator and his or her research team
  9. Participant must sign an Informed Consent Form prior to any study specific procedures and entry into the study

Exclusion Criteria:

  1. Evidence of clinically significant, unstable medical conditions as assessed by the investigator
  2. Excisional biopsy performed on the lesion to be treated in this study
  3. Recent therapy(ies) to the BCC treatment area
  4. Recurrent BCC (previously treated) at the site presented for treatment
  5. BCC lesion to be treated is located in an area where excisional biopsy is undesired or aesthetically unacceptable to the participant
  6. Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose.
  7. Participant with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix
  8. Concomitant disease requiring systemic immunosuppressive treatment
  9. Genetic skin cancer disorder, e.g., basal cell nevus syndrome
  10. Participant is pregnant or breastfeeding
  11. Treatment with another investigational drug, device, or other intervention within 3 months prior to the Screening Visit
  12. 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
Open or close this module Contacts/Locations
Central Contact Person: Michael J Fare
Telephone: 2036714351
Email: mfare@skinjectpatch.com
Study Officials: Shirley Steiner
Study Director
InClinica, Inc.
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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