search
Back to results

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

Primary Purpose

Carcinoma, Basal Cell (BCC)

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Treatment with BSCT
Sponsored by
Biosceptre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Basal Cell (BCC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female adults ≥ 18 years of age;
  • One primary histologically confirmed BCC lesion, not located on the hand or foot, suitable for surgical excision, with a minimum area of 0.5 cm2 and a maximum diameter of 2.0 cm (histological diagnosis made no more than 4 weeks prior to the Screening visit.
  • Willing to refrain from using non-approved lotions or creams on the BCC treatment site and surrounding area during the treatment period and from washing the treated area for at least 8 hours following each application of study medication;
  • Ability to follow study instructions and likely to complete all study requirements;
  • Written informed consent obtained, including consent for biopsy tissue to be examined and stored by the central dermatopathologist;
  • Written consent to allow photographs of the BCC lesion to be used as part of the study data;
  • For females of childbearing potential, a negative pregnancy test at Screening and use of an acceptable form of birth control.

Exclusion Criteria:

  • Pregnant, lactating, or planning pregnancy during the study;
  • Presence of known or suspected systemic cancer;
  • Histological evidence of squamous cell carcinoma (SCC) or any tumor other than BCC in the biopsy specimen;
  • Histological evidence of severe squamous metaplasia, infiltrative, desmoplastic, or micronodular growth patterns in the biopsy specimen;
  • Evidence of dermatological disease or confounding skin condition within the 25-cm2 treatment area, eg, SCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, or xeroderma pigmentosa;
  • Concurrent disease or treatment that suppresses the immune system;
  • Chronic medical condition that in the judgment of the investigator would interfere with the performance of the study or would place the patient at undue risk;
  • Known sensitivity to any of the ingredients in the study medication;
  • Treatment with systemic chemotherapeutic agents (eg, methotrexate, paclitaxel) within the 6 months prior to the Baseline visit;
  • Use of systemic retinoids within the 6 months prior to the Baseline visit;
  • Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the Baseline visit;
  • Use of topical immunomodulators within 2 cm of the target treatment area within the 4 weeks prior to the Baseline visit;
  • Treatment with topical agents for the treatment of BCC or actinic keratosis within 2 cm of the target treatment area within the 4 weeks prior to the Baseline visit:
  • Treatment with liquid nitrogen, surgical excision or curettage within 2 cm of the target treatment area during the 4 weeks prior to the Baseline visit;
  • Clinically significant abnormalities as noted in the screening ECG, physical examination, or laboratory test results;
  • Evidence of current chronic alcohol or drug abuse which, in the investigator's opinion, might interfere with the subject's adherence to protocol requirements;
  • Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the Baseline visit;
  • In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions of the protocol and complete the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment with BSCT

    Arm Description

    21 patients with BCC were treated with BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days.

    Outcomes

    Primary Outcome Measures

    Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
    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.
    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.
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    October 21, 2015
    Last Updated
    March 15, 2016
    Sponsor
    Biosceptre
    Collaborators
    TKL Research, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02587819
    Brief Title
    Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Biosceptre
    Collaborators
    TKL Research, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a Phase 1, open-label, single-arm, multicenter study to assess the safety and tolerability of BSCT (anti-nf-P2X7) 10% Ointment in subjects with BCC.
    Detailed Description
    The purpose of the trial was to determine the safety and tolerability of BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days in male and female patients with BCC; and to determine the steady-state pharmacokinetics (PK) of the active pharmaceutical ingredient (total sheep Immunoglobulin G [IgG]) when BSCT (anti-nf-P2X7) 10% Ointment is applied twice daily to BCC lesions. This was an open-label, single-arm, multicenter Phase 1 study that enrolled 21 BCC patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Basal Cell (BCC)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment with BSCT
    Arm Type
    Experimental
    Arm Description
    21 patients with BCC were treated with BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days.
    Intervention Type
    Drug
    Intervention Name(s)
    Treatment with BSCT
    Other Intervention Name(s)
    BSCT (anti-nf-P2X7) 10% Ointment
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
    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
    Title
    Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.
    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
    Title
    Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female adults ≥ 18 years of age; One primary histologically confirmed BCC lesion, not located on the hand or foot, suitable for surgical excision, with a minimum area of 0.5 cm2 and a maximum diameter of 2.0 cm (histological diagnosis made no more than 4 weeks prior to the Screening visit. Willing to refrain from using non-approved lotions or creams on the BCC treatment site and surrounding area during the treatment period and from washing the treated area for at least 8 hours following each application of study medication; Ability to follow study instructions and likely to complete all study requirements; Written informed consent obtained, including consent for biopsy tissue to be examined and stored by the central dermatopathologist; Written consent to allow photographs of the BCC lesion to be used as part of the study data; For females of childbearing potential, a negative pregnancy test at Screening and use of an acceptable form of birth control. Exclusion Criteria: Pregnant, lactating, or planning pregnancy during the study; Presence of known or suspected systemic cancer; Histological evidence of squamous cell carcinoma (SCC) or any tumor other than BCC in the biopsy specimen; Histological evidence of severe squamous metaplasia, infiltrative, desmoplastic, or micronodular growth patterns in the biopsy specimen; Evidence of dermatological disease or confounding skin condition within the 25-cm2 treatment area, eg, SCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, or xeroderma pigmentosa; Concurrent disease or treatment that suppresses the immune system; Chronic medical condition that in the judgment of the investigator would interfere with the performance of the study or would place the patient at undue risk; Known sensitivity to any of the ingredients in the study medication; Treatment with systemic chemotherapeutic agents (eg, methotrexate, paclitaxel) within the 6 months prior to the Baseline visit; Use of systemic retinoids within the 6 months prior to the Baseline visit; Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the Baseline visit; Use of topical immunomodulators within 2 cm of the target treatment area within the 4 weeks prior to the Baseline visit; Treatment with topical agents for the treatment of BCC or actinic keratosis within 2 cm of the target treatment area within the 4 weeks prior to the Baseline visit: Treatment with liquid nitrogen, surgical excision or curettage within 2 cm of the target treatment area during the 4 weeks prior to the Baseline visit; Clinically significant abnormalities as noted in the screening ECG, physical examination, or laboratory test results; Evidence of current chronic alcohol or drug abuse which, in the investigator's opinion, might interfere with the subject's adherence to protocol requirements; Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the Baseline visit; In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions of the protocol and complete the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Angus Gidely-Baird, PhD
    Organizational Affiliation
    Scientific Director - Biosceptre
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs