Clinical Trials Logo

Clinical Trial Summary

This study is designed as a double-blinded proof of concept of feasibility study to define if the immunosuppression associated with photodynamic therapy (PDT) can be blocked by treatment with cyclo-oxygenase-2 (COX-2) inhibitor celecoxib in comparison to placebo. PDT consists of application of the photosensitizer 5-aminolevulinic acid followed by treatment with a blue light. PDT is used to treat pre-cancerous actinic keratosis on large areas of skin. These studies are a continuation of ongoing studies that indicate that the lipid mediator platelet-activating factor (PAF) is generated in skin following PDT, and that PDT suppresses the immune system. It is hypothesized that PDT-generated PAF results in the immunosuppression associated with PDT. Therefore, it is proposed that a treatment to block that immunosuppression could protect the patient undergoing PDT. Blockers of the PAF system are not currently commercially available. However research studies done at Wright State University using mice indicate that PAF- and PDT-induced immunosuppression is blocked by treatment with COX-2 inhibitors. This study is conducted as a proof of concept. Study length and visit for subjects with actinic keratoses: The first part of the study is completed in 12 days then there are follow up visits at 6 and 12 months. There are a total of 6 separate visits to the research office. Study length and visit for control subjects: The study is completed in 10 days. There are a total of 4 separate visits to the research office.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03643744
Study type Interventional
Source Wright State University
Contact
Status Completed
Phase Phase 1
Start date April 1, 2019
Completion date March 21, 2023

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
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 NCT02938715 - Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil N/A