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Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)

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ClinicalTrials.gov Identifier: NCT03646188
Recruitment Status : Terminated (Application of arrays was inconsistent.)
First Posted : August 24, 2018
Results First Posted : August 17, 2022
Last Update Posted : August 18, 2022
Sponsor:
Information provided by (Responsible Party):
SkinJect, Inc.

Tracking Information
First Submitted Date  ICMJE August 22, 2018
First Posted Date  ICMJE August 24, 2018
Results First Submitted Date  ICMJE January 26, 2022
Results First Posted Date  ICMJE August 17, 2022
Last Update Posted Date August 18, 2022
Actual Study Start Date  ICMJE June 10, 2020
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2022)
Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale [ Time Frame: 4 weeks ]
Dose Limiting Toxicity (DLT) in Trial Subjects Assessed by Local Skin Response Grading Scale, 0-4, 4 being the worst dermal response
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
Dose limiting toxicity (DLT) and maximum tolerated dose (MTD) [ Time Frame: 4 weeks ]
Presence or absence of cutaneous reactions to the D-MNA application
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2022)
Number of Participants With Eradicated Basal Cell Carcinoma as Measured by Histological Analysis [ Time Frame: 4 weeks ]
Histological confirmation by central reading by pathologist of basal cell carcinoma eradication in trial participants
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
Efficacy as measured by histological analysis [ Time Frame: 4 weeks ]
Histological confirmation of basal cell carcinoma eradication
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)
Official Title  ICMJE 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)
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).
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
3+3 Design
Masking: None (Open Label)
Masking Description:
Placebo
Primary Purpose: Treatment
Condition  ICMJE Basal Cell Carcinoma
Intervention  ICMJE
  • Drug: Placebo-containing MNA
    A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.
    Other Name: Placebo
  • 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 Name: 25 µg D-MNA
  • 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 Name: 50 µg D-MNA
  • 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 Name: 100 µg D-MNA
  • 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 Name: 200 µg D-MNA
Study Arms  ICMJE
  • Placebo Comparator: Placebo-containing MNA
    Placebo
    Intervention: Drug: Placebo-containing MNA
  • Experimental: 25 µg Doxorubicin-containing MNA
    D-MNA's containing 25 µg of doxorubicin hydrochloride
    Intervention: Drug: 25 µg doxorubicin-containing MNA
  • Experimental: 50 µg Doxorubicin-containing MNA
    D-MNA's containing 50 µg of doxorubicin hydrochloride
    Intervention: Drug: 50 µg doxorubicin-containing MNA
  • Experimental: 100 µg Doxorubicin-containing MNA
    D-MNA's containing 100 µg of doxorubicin hydrochloride
    Intervention: Drug: 100 µg doxorubicin-containing MNA
  • Experimental: 200 µg Doxorubicin-containing MNA
    D-MNA's containing 200 µg of doxorubicin hydrochloride
    Intervention: Drug: 200 µg doxorubicin-containing MNA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 11, 2021)
13
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2018)
30
Actual Study Completion Date  ICMJE May 4, 2021
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03646188
Other Study ID Numbers  ICMJE SKNJCT-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party SkinJect, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE SkinJect, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gregory Suplick InClinica, Inc.
PRS Account SkinJect, Inc.
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP