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

NCT02587819 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-04-14

Study results available
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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.

Conditions

  • Carcinoma, Basal Cell (BCC)

Interventions

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.

Sponsors & Collaborators

  • TKL Research, Inc.

    collaborator INDUSTRY

  • Biosceptre

    lead INDUSTRY

Principal Investigators

  • Angus Gidely-Baird, PhD · Scientific Director - Biosceptre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-10-31
Completion
2014-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02587819 on ClinicalTrials.gov