CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
Treatment with BSCTdrug
Likely dose
Treatment with BSCT 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02587819
NCT02587819Phase 1Completed

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

Biosceptre·interventional·Posted Oct 27, 2015·Updated Apr 14, 2016

In Brief

A Phase 1 clinical trial evaluating Treatment with BSCT for Carcinoma, Basal Cell (BCC). Completed, enrolled 21 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsTKL Research, Inc.

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 27, 2015
Enrollment StartMay 1, 2013
Primary CompletionOct 1, 2013
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.7 years ago

Interventions

Treatment with BSCTdrug

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.