Actinic Keratosis Clinical Trial
Official title:
Photodynamic Therapy-Induced Immune Modulation: Part III
NCT number | NCT03643744 |
Other study ID # | 06499 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | March 21, 2023 |
Verified date | January 2024 |
Source | Wright State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | March 21, 2023 |
Est. primary completion date | March 21, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years and older |
Eligibility | Inclusion Criteria for Control Subjects: - Adult age 45 or older - Caucasian (Fair skin, Fitzpatrick types I and II) - Ability to understand and consent to the instructions of the study - Have access to stable transportation Inclusion Criteria for Study Subjects: - Wright State University dermatologist has prescribed PDT for the treatment of actinic damage (Presence of precancerous actinic keratoses whose treatment necessitates PDT with the BLU-U). - Undergoing PDT on greater than 5% body surface area: face and scalp, face and dorsal surface of arms, face and chest, face and back, or dorsal surface of arms alone, chest alone, or back alone. - Caucasian (Fair skin, Fitzpatrick types I and II) - Adult-age 45 or older - Ability to understand the informed consent and comply with instructions and have stable transportation. Exclusion Criteria for All Subjects: - PDT on less than 5% body surface area (eg, forehead) - Present treatment with corticosteroids or Non-steroidal inflammatory drugs (e.g., cyclooxygenase inhibitors) within past 2 months (except low-dose 81 mg aspirin). - On antioxidant supplements (e.g., vitamin C) for past 2 months - Tanning bed use within last 3 months - PDT treatments within last 3 months - Significant health issues that could affect the immune system (e.g., uncontrolled Diabetes Mellitus, Rheumatoid arthritis, skin rashes, psoriasis) that could interfere with testing - Pregnant or nursing - No immunosuppression, and on no immunosuppressive medications or NSAIDS within past 30 days (except low-dose [81 mg daily] aspirin). - No significant underlying diseases that could potentially interfere with the immune assays or cardiac or renal or liver problems. - History of blood clot or hypercoagulable state or GI bleed/ulceration. |
Country | Name | City | State |
---|---|---|---|
United States | Wright State Physicians | Fairborn | Ohio |
Lead Sponsor | Collaborator |
---|---|
Wright State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Photodynamic Therapy (PDT)-induced Systemic Immunosuppression From Baseline with Celecoxib Treatment. | Investigator will assess change through clinical laboratory values and reactions to skin testing. | Day 7 | |
Primary | Change From Baseline in the Number of Actinic Keratosis at 6 months. | Investigator will assess the number of actinic keratosis in the PDT-treated areas. | 6 Months | |
Primary | Change From Baseline in the Number of Actinic Keratosis at 12 months. | Investigator will assess the number of actinic keratosis in the PDT-treated areas. | 12 Months |
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 | |
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 |
NCT02878382 -
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT
|
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 |