Study of SOR007 Ointment for Actinic Keratosis

Status Completed

Clinical Trial 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.

Clinical Trial Description

In this Phase 2, randomized, double-blind, dose rising trial, subjects with actinic keratosis will receive topical application of SOR007 Ointment (in four concentrations) or SOR007 Ointment vehicle to the face twice daily for up to 28 days. Subjects will be enrolled in four dose-escalating cohorts of eight subjects and randomized to SOR0007 or Ointment vehicle in a ratio of 3:1. Cohorts will be enrolled sequentially starting at the lowest concentration.

Safety will be assessed in an ongoing manner and formal safety reviews will be conducted four times for each cohort: at Day 8, Day 15, Day 21, and Day 28 for the last subject enrolled in each cohort. The next dose level cohort will enroll upon a finding of safety and tolerability at the previous cohort's second (Day 15) safety review.

The safety and tolerability of SOR007 will be demonstrated by local toxicity, adverse events, laboratory assessments and vital signs. Subjects will be observed for reduction in the number of AK lesions to determine preliminary efficacy. Plasma samples will be taken at various time points throughout the study to characterize the pharmacokinetics of SOR007. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03083470
Study type	Interventional
Source	DFB Soria, LLC
Contact
Status	Completed
Phase	Phase 2
Start date	May 18, 2017
Completion date	March 12, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03013647` - Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization	N/A
Completed	`NCT02674048` - Metvix Daylight PDT in Actinic Keratosis
Completed	`NCT02421471` - PMS to Evaluate the Safety and Efficacy of Picato® Gel
Completed	`NCT02239679` - Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy	Phase 2
Completed	`NCT01686152` - Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis	Phase 3
Terminated	`NCT01525329` - Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease	Phase 3
Completed	`NCT01444989` - Development and Validation of a Quality of Life Instrument for Actinic Keratosis	N/A
Completed	`NCT01449513` - PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy	Phase 1
Terminated	`NCT01203878` - Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy	Phase 4
Completed	`NCT00989313` - A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study	Phase 3
Completed	`NCT00306800` - Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp	Phase 3
Completed	`NCT00375739` - Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses	Phase 2
Completed	`NCT03285490` - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)	Phase 3
Completed	`NCT03319251` - Biomarker Database Registry for Photodynamic Therapy
Completed	`NCT02866695` - Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients	Phase 4
Completed	`NCT02952898` - Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses	Phase 3
Completed	`NCT02984072` - Menthol for PDT Pain Relief	Phase 4
Recruiting	`NCT03684772` - Topical Ionic Contra-Viral Therapy in Actinic Keratosis	Phase 2
Completed	`NCT02938715` - Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil	N/A
Completed	`NCT02878382` - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT	N/A