Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment
Condition: Carcinoma, Basal Cell (BCC)
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: Treatment with BSCT
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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.