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
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Basal Cell (BCC)||Drug: Treatment with BSCT||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase 1 Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment When Applied Twice Daily for 28 Days in Male and Female Patients With Basal Cell Carcinoma|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||April 2014|
Experimental: Treatment with BSCT
21 patients with BCC were treated with BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days.
Drug: Treatment with BSCT
The study product BSCT (anti-nf-P2X7) 10% Ointment was anti-nf-P2X7 (highly purified sheep IgG) in an ointment formulation for topical administration. The formulation contained 10% weight by weight of the active pharmaceutical ingredient in an anhydrous ointment base.
Fifty (50) to 100 mg of product (an amount the size of a small pea) was applied topically twice a day for 28 days to a 25 cm2 area of skin containing a single BCC lesion. The product was to be applied in the morning and in the evening after washing.
Other Name: BSCT (anti-nf-P2X7) 10% Ointment
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 8 weeks ]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.
- Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA. [ Time Frame: 28 days ]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.
- Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay. [ Time Frame: 8 weeks ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587819
|Study Director:||Angus Gidely-Baird, PhD||Scientific Director - Biosceptre|