Study of SOR007 Ointment for Actinic Keratosis

PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

May 18, 2017

Primary Completion Date

March 12, 2018

Study Completion Date

March 12, 2018

Conditions
Actinic Keratosis
Interventions
DRUG

SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment

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.

OTHER

SOR007 Ointment Vehicle

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.

Trial Locations (1)

33609

Moore Clinical Research, Tampa

All Listed Sponsors
collaborator

US Biotest, Inc.

INDUSTRY

lead

DFB Soria, LLC

INDUSTRY

NCT03083470 - Study of SOR007 Ointment for Actinic Keratosis | Biotech Hunter | Biotech Hunter