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Trial record 3 of 4 for:    sor007

Study of SOR007 Ointment for Actinic Keratosis

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ClinicalTrials.gov Identifier: NCT03083470
Recruitment Status : Completed
First Posted : March 20, 2017
Results First Posted : April 25, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
DFB Soria, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Actinic Keratosis
Interventions Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment
Other: SOR007 Ointment Vehicle
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SOR007 0.15% SOR007 0.3% SOR007 1.0% SOR007 2.0% Ointment Vehicle
Hide Arm/Group Description SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Period Title: Overall Study
Started 6 6 6 6 9
Completed 6 6 6 6 7
Not Completed 0 0 0 0 2
Reason Not Completed
Lost to Follow-up             0             0             0             0             1
Withdrawal by Subject             0             0             0             0             1
Arm/Group Title SOR007 0.15% SOR007 0.3% SOR007 1.0% SOR007 2.0% Ointment Vehicle Total
Hide Arm/Group Description SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 9 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 9 participants 33 participants
68.2  (6.24) 67.5  (8.07) 62.3  (7.31) 62.2  (11.84) 62.6  (7.65) 64.4  (8.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 9 participants 33 participants
Female
4
  66.7%
1
  16.7%
4
  66.7%
5
  83.3%
6
  66.7%
20
  60.6%
Male
2
  33.3%
5
  83.3%
2
  33.3%
1
  16.7%
3
  33.3%
13
  39.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 9 participants 33 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
2
  33.3%
0
   0.0%
2
  22.2%
4
  12.1%
Not Hispanic or Latino
6
 100.0%
6
 100.0%
4
  66.7%
6
 100.0%
7
  77.8%
29
  87.9%
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 6 participants 6 participants 6 participants 6 participants 9 participants 33 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
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
9
 100.0%
33
 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 6 participants 6 participants 6 participants 6 participants 9 participants 33 participants
6 6 6 6 9 33
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events
Hide Description Treatment emergent adverse events including all reported adverse events, laboratory assessments, physical examination findings, and vital signs.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SOR007 0.15% SOR007 0.3% SOR007 1.0% SOR007 2.0% Ointment Vehicle
Hide Arm/Group Description:
SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Overall Number of Participants Analyzed 6 6 6 6 9
Measure Type: Count of Participants
Unit of Measure: Participants
2
  33.3%
1
  16.7%
3
  50.0%
1
  16.7%
1
  11.1%
2.Secondary Outcome
Title Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of SOR007
Hide Description Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SOR007 0.15% SOR007 0.3% SOR007 1.0% SOR007 2.0% Ointment Vehicle
Hide Arm/Group Description:
SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Overall Number of Participants Analyzed 6 6 6 6 9
Mean (Standard Deviation)
Unit of Measure: pg·hr/mL
NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 180  (45.0) NA [1]   (NA)
[1]
Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.
3.Secondary Outcome
Title Pharmacokinetics: Peak Plasma Concentration (Cmax) of SOR007
Hide Description Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SOR007 0.15% SOR007 0.3% SOR007 1.0% SOR007 2.0% Ointment Vehicle
Hide Arm/Group Description:
SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Overall Number of Participants Analyzed 6 6 6 6 9
Mean (Standard Deviation)
Unit of Measure: pg/mL
NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 18.3  (3.61) NA [1]   (NA)
[1]
Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.
4.Secondary Outcome
Title Pharmacokinetics: Time at Which Peak Plasma Concentration is Observed (Tmax) of SOR007
Hide Description Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SOR007 0.15% SOR007 0.3% SOR007 1.0% SOR007 2.0% Ointment Vehicle
Hide Arm/Group Description:
SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Overall Number of Participants Analyzed 6 6 6 6 9
Mean (Standard Deviation)
Unit of Measure: hr
NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 1.33  (2.31) NA [1]   (NA)
[1]
Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.
5.Secondary Outcome
Title Percent Change in Number of AK Lesions
Hide Description AK lesions in the target test field were photographed and tracings were created at baseline and at subsequent visits to track whether lesions were clear or still present.
Time Frame Baseline and 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects, both receiving Vehicle, were withdrawn early from the study; one of these subjects participated long enough to be included in the analysis of the efficacy endpoint and one did not. Therefore, there are 8 subjects in the Ointment Vehicle arm of the study.
Arm/Group Title SOR007 0.15% SOR007 0.3% SOR007 1.0% SOR007 2.0% Ointment Vehicle
Hide Arm/Group Description:
SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Overall Number of Participants Analyzed 6 6 6 6 8
Mean (Standard Deviation)
Unit of Measure: Percent Change
-34.68  (27.432) -34.72  (27.576) -53.06  (18.868) -58.33  (30.277) -48.75  (22.321)
6.Secondary Outcome
Title Percent Change in Size of AK Lesions
Hide Description Percent change in size of AK lesions was determined with measurements obtained at Baseline and 56 days. A measurement was also obtained at Day 28, but was not used to calculated percent change for the purposes of this outcome measure.
Time Frame Baseline and 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects, both receiving Vehicle, were withdrawn early from the study; one of these subjects participated long enough to be included in the analysis of the efficacy endpoint and one did not. Therefore, there are 8 subjects in the Ointment Vehicle arm of the study.
Arm/Group Title SOR007 0.15% SOR007 0.3% SOR007 1.0% SOR007 2.0% Ointment Vehicle
Hide Arm/Group Description:
SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Overall Number of Participants Analyzed 6 6 6 6 8
Mean (Standard Deviation)
Unit of Measure: Percent Change
-46.20  (25.698) -35.83  (17.811) -58.12  (15.989) -62.32  (27.544) -59.22  (24.169)
Time Frame 56 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SOR007 0.15% SOR007 0.3% SOR007 1.0% SOR007 2.0% Ointment Vehicle
Hide Arm/Group Description SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated. SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
All-Cause Mortality
SOR007 0.15% SOR007 0.3% SOR007 1.0% SOR007 2.0% Ointment Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/9 (0.00%)    
Hide Serious Adverse Events
SOR007 0.15% SOR007 0.3% SOR007 1.0% SOR007 2.0% Ointment Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SOR007 0.15% SOR007 0.3% SOR007 1.0% SOR007 2.0% Ointment Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      1/6 (16.67%)      3/6 (50.00%)      1/6 (16.67%)      1/9 (11.11%)    
Blood and lymphatic system disorders           
Thrombocytopenia * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/9 (0.00%)  0
Gastrointestinal disorders           
Abdominal distension * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/9 (0.00%)  0
Diarrhoea * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/9 (0.00%)  0
Irritable bowel syndrome * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/9 (11.11%)  1
General disorders           
Chest discomfort * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/9 (0.00%)  0
Fatigue * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/9 (0.00%)  0
Impaired healing * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/9 (0.00%)  0
Pain * 1  0/0  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/9 (0.00%)  0
Infections and infestations           
Sinusitis * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/9 (0.00%)  0
Injury, poisoning and procedural complications           
Limb injury * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/9 (11.11%)  1
Sunburn * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/9 (0.00%)  0
Fall * 1  0/0  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/9 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Myalgia * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/9 (0.00%)  0
Reproductive system and breast disorders           
Breast Pain * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Oropharyngeal pain * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/9 (0.00%)  0
Upper respiratory tract congestion * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders           
Skin irritation * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/9 (0.00%)  0
Swelling face * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/9 (0.00%)  0
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Gere diZerega, MD; President & CEO
Organization: US Biotest, Inc.
Phone: 805-595-1300
EMail: gere.dizerega@usbiotest.com
Layout table for additonal information
Responsible Party: DFB Soria, LLC
ClinicalTrials.gov Identifier: NCT03083470    
Other Study ID Numbers: SOR007-2017-04
First Submitted: March 14, 2017
First Posted: March 20, 2017
Results First Submitted: April 2, 2019
Results First Posted: April 25, 2019
Last Update Posted: May 15, 2019