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Trial record 23 of 452 for:    applied AND ointment

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02587819
Recruitment Status : Completed
First Posted : October 27, 2015
Results First Posted : March 15, 2016
Last Update Posted : April 14, 2016
TKL Research, Inc.
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Basal Cell (BCC) Drug: Treatment with BSCT Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02587819

Sponsors and Collaborators
TKL Research, Inc.
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Study Director: Angus Gidely-Baird, PhD Scientific Director - Biosceptre

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Responsible Party: Biosceptre Identifier: NCT02587819     History of Changes
Other Study ID Numbers: Protocol BSCT-001
First Posted: October 27, 2015    Key Record Dates
Results First Posted: March 15, 2016
Last Update Posted: April 14, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell