CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment +1 moredrug
Likely dose
SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment 0.5gfrom 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/NCT03083470
NCT03083470Phase 2Completed
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Phase 2 Dose-Rising Study of SOR007 Ointment for Actinic Keratosis

DFB Soria, LLC·interventional·Posted Mar 20, 2017·Updated May 15, 2019

In Brief

A Phase 2 clinical trial evaluating SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment and SOR007 Ointment Vehicle for Actinic Keratosis. Completed, enrolled 33 participants across 1 site.

Detailed Summary

A Phase 2, randomized, double-blind, dose rising study to determine the safety, tolerability, and preliminary efficacy of four concentrations of SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment (SOR007) compared to SOR007 ointment vehicle applied to actinic keratosis (AK) lesions on the face twice daily for up to 28 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesUnited States
CollaboratorsUS Biotest, Inc.

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 20, 2017
Enrollment StartMay 18, 2017
Primary CompletionMar 12, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.3 years ago

Interventions

SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointmentdrug

SOR007 will be applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolve. The maximum total amount of SOR007 that will be applied daily will be 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, will be treated.

SOR007 Ointment Vehicleother

SOR007 ointment vehicle will be applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolve. The maximum total amount of Ointment vehicle that will be applied daily will be 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, will be treated.