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Trial record 23 of 453 for:    applied AND ointment

Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment

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ClinicalTrials.gov Identifier: NCT02587819
Recruitment Status : Completed
First Posted : October 27, 2015
Results First Posted : March 15, 2016
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
Biosceptre

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Basal Cell (BCC)
Intervention Drug: Treatment with BSCT
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment With BSCT
Hide Arm/Group Description BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
Period Title: Overall Study
Started 21
Exposed 21
Completed 19
Not Completed 2
Reason Not Completed
Adverse Event             1
Lost to Follow-up             1
Arm/Group Title Treatment With BSCT
Hide Arm/Group Description BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
65.0  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
8
  38.1%
Male
13
  61.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
21
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
21
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Hide Description Adverse events and any changes in physical examinations will be monitored, as described in the Code of Federal Regulations (CFR) Title 21 Part 312. In particular local cutaneous irritation including erythema, peeling, dryness, itching, and burning/ stinging that first occur during the study or represent a worsening from Baseline will be recorded as AEs.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.
Arm/Group Title Treatment With BSCT
Hide Arm/Group Description:
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days post baseline to all subjects. All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments at 57 days post-Baseline.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
Subjects with any Serious Adverse Events 1
Subjects with Treatment-emergent Adverse Event(s) 12
2.Primary Outcome
Title Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.
Hide Description To determine PK, blood levels of sheep IgG were measured in samples collected at Visit 2 (Baseline), Visit 5, predose at Visit 6 (EOT), and then at 1 h, 2 h, and 4 h after the last dose of study medication.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
At all timepoints, the serum concentration of sheep IgG was too low to be quantified in most of the subjects. One subject had measurable sheep IgG at 1 hr post dose at Visit 6 (EOT) and 3 other subjects had measurable sheep IgG at predose timepoints. In outcome measure below NA represents readings less than lower limit of quantification.
Arm/Group Title Treatment With BSCT
Hide Arm/Group Description:
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
Overall Number of Participants Analyzed 21
Median (Full Range)
Unit of Measure: ng/ml
Pre-dose - Baseline visit
NA [1] 
(NA to NA)
Pre dose - Visit 5
NA [2] 
(NA to 24.68)
Pre dose - Visit 6
NA [2] 
(NA to 22.85)
1 hour post dose - Visit 6
NA [2] 
(NA to 7.08)
2 hours post dose - Visit 6
NA [1] 
(NA to NA)
4 hours post dose - Visit 6
NA [1] 
(NA to NA)
[1]
All patients had levels of sheep IgG below limit of quantitation.
[2]
The majority of patients had levels of sheep IgG below limit of quantitation.
3.Primary Outcome
Title Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.
Hide Description The active ingredient of BSCT is sheep IgG which may causes an immunogenic response if it enters the systemic circulation. To monitor this response patient blood samples collected at Screening, Visit 2 (Baseline), Visit 6 (EOT), and at Visit 8 (EOS) was tested for anti-sheep IgG antibodies (indicative of immune response against API).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Anti sheep IgG antibody titres were measured from 21 subjects at screening and baseline, 20 subjects at Visit 6 (Day 29 EOT) and 19 subjects at Visit 8 (Day 57 follow up). The percentage of patients with detectable anti sheep antibodies is reported.
Arm/Group Title Treatment With BSCT
Hide Arm/Group Description:
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: percentage of subjects
Subjects with anti sheep IgG at screening 42.9
Subjects with anti sheep IgG at Baseline 38.1
Subjects with anti sheep IgG at visit 6 50
Subjects with anti sheep IgG at visit 8 52.6
4.Post-Hoc Outcome
Title Change in Lesion Size.
Hide Description BCC lesion area was measured at Baseline and after 28 days treatment. Percantage change in lesion area was caculated.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Final area of lesion was not recorded for one subject.
Arm/Group Title Treatment With BSCT
Hide Arm/Group Description:
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
Overall Number of Participants Analyzed 20
Mean (Standard Error)
Unit of Measure: percentage change in tumour area
-12.86  (5.88)
Time Frame 8 weeks (28 day treatment period and 28 day follow up period).
Adverse Event Reporting Description All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.
 
Arm/Group Title Treatment With BSCT
Hide Arm/Group Description BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
All-Cause Mortality
Treatment With BSCT
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment With BSCT
Affected / at Risk (%) # Events
Total   1/21 (4.76%)    
Cardiac disorders   
Acute myocardial infarction * 1 [1]  1/21 (4.76%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15)
[1]
Subject 01-007 experienced a myocardial infarction from 9 September 2013 (Study Day 49) to 11 September 2013 (Study Day 51), which was moderate and was considered to be unrelated to study medication.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment With BSCT
Affected / at Risk (%) # Events
Total   12/21 (57.14%)    
Gastrointestinal disorders   
Diarrhoea * 1  1/21 (4.76%)  1
General disorders   
Application site dryness * 1  7/21 (33.33%)  7
Application site erythema * 1  10/21 (47.62%)  10
Application site exfoliation * 1  5/21 (23.81%)  5
Application site pain * 1  3/21 (14.29%)  3
Application site pruritus * 1  5/21 (23.81%)  5
Infections and infestations   
Sinusitis * 1  1/21 (4.76%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15)
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
Name/Title: Dr Shaun McNulty
Organization: Biosceptre UK
Phone: 01223496092
Responsible Party: Biosceptre
ClinicalTrials.gov Identifier: NCT02587819     History of Changes
Other Study ID Numbers: Protocol BSCT-001
First Submitted: October 21, 2015
First Posted: October 27, 2015
Results First Submitted: January 20, 2016
Results First Posted: March 15, 2016
Last Update Posted: April 14, 2016