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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.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Basal Cell Carcinoma
Interventions Drug: Placebo-containing MNA
Drug: 25 µg doxorubicin-containing MNA
Drug: 50 µg doxorubicin-containing MNA
Drug: 100 µg doxorubicin-containing MNA
Drug: 200 µg doxorubicin-containing MNA
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo-containing MNA 25 µg Doxorubicin-containing MNA 50 µg Doxorubicin-containing MNA 100 µg Doxorubicin-containing MNA 200 µg Doxorubicin-containing MNA
Hide Arm/Group Description

Placebo

Placebo-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.

D-MNA's containing 25 µg of doxorubicin hydrochloride

25 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.

D-MNA's containing 50 µg of doxorubicin hydrochloride

50 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.

D-MNA's containing 100 µg of doxorubicin hydrochloride

100 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.

D-MNA's containing 200 µg of doxorubicin hydrochloride

200 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.

Period Title: Overall Study
Started 3 3 3 3 1
Completed 3 3 3 3 1
Not Completed 0 0 0 0 0
Arm/Group Title Placebo-containing MNA 25 µg Doxorubicin-containing MNA 50 µg Doxorubicin-containing MNA 100 µg Doxorubicin-containing MNA 200 µg Doxorubicin-containing MNA Total
Hide Arm/Group Description

Placebo

Placebo-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.

D-MNA's containing 25 µg of doxorubicin hydrochloride

25 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.

D-MNA's containing 50 µg of doxorubicin hydrochloride

50 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.

D-MNA's containing 100 µg of doxorubicin hydrochloride

100 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.

D-MNA's containing 200 µg of doxorubicin hydrochloride

200 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.

Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 3 1 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 1 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  33.3%
2
  66.7%
2
  66.7%
0
   0.0%
0
   0.0%
5
  38.5%
>=65 years
2
  66.7%
1
  33.3%
1
  33.3%
3
 100.0%
1
 100.0%
8
  61.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 3 participants 1 participants 13 participants
64.67  (31.72) 61.33  (8.505) 63.33  (12.34) 79  (6.08) 67 [1]   (NA) 67.35  (14.48)
[1]
There was only 1 subject in this dose cohort.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 1 participants 13 participants
Female
0
   0.0%
1
  33.3%
2
  66.7%
1
  33.3%
0
   0.0%
4
  30.8%
Male
3
 100.0%
2
  66.7%
1
  33.3%
2
  66.7%
1
 100.0%
9
  69.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 1 participants 13 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
   7.7%
Not Hispanic or Latino
3
 100.0%
3
 100.0%
2
  66.7%
3
 100.0%
1
 100.0%
12
  92.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 1 participants 13 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
1
 100.0%
13
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 3 participants 3 participants 1 participants 13 participants
3 3 3 3 1 13
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale
Hide Description Dose Limiting Toxicity (DLT) in Trial Subjects Assessed by Local Skin Response Grading Scale, 0-4, 4 being the worst dermal response
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable subjects
Arm/Group Title Placebo-containing MNA 25 µg Doxorubicin-containing MNA 50 µg Doxorubicin-containing MNA 100 µg Doxorubicin-containing MNA 200 µg Doxorubicin-containing MNA
Hide Arm/Group Description:

Placebo

Placebo-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.

D-MNA's containing 25 µg of doxorubicin hydrochloride

25 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.

D-MNA's containing 50 µg of doxorubicin hydrochloride

50 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.

D-MNA's containing 100 µg of doxorubicin hydrochloride

100 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.

D-MNA's containing 200 µg of doxorubicin hydrochloride

200 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.

Overall Number of Participants Analyzed 3 3 3 3 1
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0
2.Secondary Outcome
Title Number of Participants With Eradicated Basal Cell Carcinoma as Measured by Histological Analysis
Hide Description Histological confirmation by central reading by pathologist of basal cell carcinoma eradication in trial participants
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable subjects
Arm/Group Title Placebo-containing MNA 25 µg Doxorubicin-containing MNA 50 µg Doxorubicin-containing MNA 100 µg Doxorubicin-containing MNA 200 µg Doxorubicin-containing MNA
Hide Arm/Group Description:

Placebo

Placebo-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.

D-MNA's containing 25 µg of doxorubicin hydrochloride

25 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.

D-MNA's containing 50 µg of doxorubicin hydrochloride

50 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.

D-MNA's containing 100 µg of doxorubicin hydrochloride

100 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.

D-MNA's containing 200 µg of doxorubicin hydrochloride

200 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.

Overall Number of Participants Analyzed 3 3 3 3 1
Measure Type: Number
Unit of Measure: Participants
1 2 1 1 1
Time Frame 50 days
Adverse Event Reporting Description Adverse events were recorded throughout the study and at early discontinuation. AEs and medical conditions were coded using the Medical Dictionary for Regulatory Activities (MedDRA) (Version 22.0). Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the initiation of treatment or any event already present that worsened in either intensity or frequency following exposure to treatment.
 
Arm/Group Title Placebo-containing MNA 25 µg Doxorubicin-containing MNA 50 µg Doxorubicin-containing MNA 100 µg Doxorubicin-containing MNA 200 µg Doxorubicin-containing MNA
Hide Arm/Group Description

Placebo

Placebo-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.

D-MNA's containing 25 µg of doxorubicin hydrochloride

25 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.

D-MNA's containing 50 µg of doxorubicin hydrochloride

50 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.

D-MNA's containing 100 µg of doxorubicin hydrochloride

100 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.

D-MNA's containing 200 µg of doxorubicin hydrochloride

200 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.

All-Cause Mortality
Placebo-containing MNA 25 µg Doxorubicin-containing MNA 50 µg Doxorubicin-containing MNA 100 µg Doxorubicin-containing MNA 200 µg Doxorubicin-containing MNA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/1 (0.00%)    
Hide Serious Adverse Events
Placebo-containing MNA 25 µg Doxorubicin-containing MNA 50 µg Doxorubicin-containing MNA 100 µg Doxorubicin-containing MNA 200 µg Doxorubicin-containing MNA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo-containing MNA 25 µg Doxorubicin-containing MNA 50 µg Doxorubicin-containing MNA 100 µg Doxorubicin-containing MNA 200 µg Doxorubicin-containing MNA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      1/3 (33.33%)      0/3 (0.00%)      0/3 (0.00%)      1/1 (100.00%)    
Skin and subcutaneous tissue disorders           
Application site pain  1 [1]  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
[1]
Pain at microneedle array application site
The study was terminated at 13 subjects. The related lack of dose-related trends observed in DLTs, clinical response and erythema was likely due to variability in MNA application. SkinJect has addressed the MNA configuration concerns that could have adversely affected doxorubicin dissolution and deposition. By optimizing the consistency of doxorubicin deposition, future trials should allow valid assessment of whether D-MNA represents an alternative to currently available treatments for BCC.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael J. Fare
Organization: SkinJect, Inc.
Phone: 203) 533-2050‬
EMail: mfare@skinjectpatch.com
Layout table for additonal information
Responsible Party: SkinJect, Inc.
ClinicalTrials.gov Identifier: NCT03646188    
Other Study ID Numbers: SKNJCT-001
First Submitted: August 22, 2018
First Posted: August 24, 2018
Results First Submitted: January 26, 2022
Results First Posted: August 17, 2022
Last Update Posted: August 18, 2022