Protocols for Painless Photodynamic Therapy (PDT) of Actinic Keratoses

Status Completed

Clinical Trial Summary

This study is being done to compare a new, continuous illumination regimen of ALA-PDT (Aminolevulinate-Photodynamic Therapy) to a conventional regimen for treatment of actinic keratoses. The hypothesis is that the continuous illumination approach will be less painful, but equally efficacious, as the old regimen.

Clinical Trial Description

This study is being done to compare a modified version of the standard ALA-PDT (Aminolevulinate-Photodynamic Therapy) treatment of actinic keratoses, to a modified version in which light exposure begins immediately after application of the Levulan. We hypothesize that this will yield a therapeutic efficacy equivalent to the standard ALA-PDT regimen, but will cause less pain during the light exposure. The study employs a bilateral design in which the left versus right sides of the treatment area are compared in the exact same patient. There are 3 arms of the study, each having a different time duration of light exposure in the modified regimen to determine which one is most efficacious ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02124733
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Completed
Phase	Phase 3
Start date	April 2014
Completion date	December 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	`NCT02239679` - Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy	Phase 2
Completed	`NCT02421471` - PMS to Evaluate the Safety and Efficacy of Picato® Gel
Completed	`NCT01686152` - Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis	Phase 3
Completed	`NCT01449513` - PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy	Phase 1
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
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	`NCT02902822` - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo	N/A
Completed	`NCT02878382` - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT	N/A