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Photodynamic Therapy-Induced Immune Modulation: Part III

Primary Purpose

Actinic Keratosis, Photodynamic Therapy

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Celecoxib 200mg

Placebo

About this trial

This is an interventional prevention trial for Actinic Keratosis focused on measuring Actinic Keratosis, Photodynamic Therapy

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Wright State PhysiciansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

PDT + Celecoxib

PDT + Placebo

Control + Celecoxib

Control + Placebo

Arm Description

Patient receiving PDT taking 200mg celecoxib.

Patient receiving PDT taking placebo.

Control subject not receiving PDT taking 200mg celecoxib.

Control subject not receiving PDT taking placebo.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03643744

First Posted

August 14, 2018

Last Updated

February 22, 2023

Sponsor

Wright State University

1. Study Identification

Unique Protocol Identification Number

NCT03643744

Brief Title

Photodynamic Therapy-Induced Immune Modulation: Part III

Official Title

Photodynamic Therapy-Induced Immune Modulation: Part III

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wright State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis, Photodynamic Therapy

Keywords

Actinic Keratosis, Photodynamic Therapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PDT + Celecoxib

Arm Type

Active Comparator

Arm Description

Patient receiving PDT taking 200mg celecoxib.

Arm Title

PDT + Placebo

Arm Type

Placebo Comparator

Arm Description

Patient receiving PDT taking placebo.

Arm Title

Control + Celecoxib

Arm Type

Active Comparator

Arm Description

Control subject not receiving PDT taking 200mg celecoxib.

Arm Title

Control + Placebo

Arm Type

Placebo Comparator

Arm Description

Control subject not receiving PDT taking placebo.

Intervention Type

Drug

Intervention Name(s)

Celecoxib 200mg

Intervention Description

14 Celecoxib 200mg taken 1 in the morning and 1 in the evening.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

14 placebo capsules taken 1 in the morning and 1 in the evening.

Primary Outcome Measure Information:

Title

Changes in Photodynamic Therapy (PDT)-induced Systemic Immunosuppression From Baseline with Celecoxib Treatment.

Description

Investigator will assess change through clinical laboratory values and reactions to skin testing.

Time Frame

Day 7

Title

Change From Baseline in the Number of Actinic Keratosis at 6 months.

Description

Investigator will assess the number of actinic keratosis in the PDT-treated areas.

Time Frame

6 Months

Title

Change From Baseline in the Number of Actinic Keratosis at 12 months.

Description

Investigator will assess the number of actinic keratosis in the PDT-treated areas.

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Manager, Clinical Research Operations

Phone

937-245-7500

pturesearch@wrightstatephysicians.org

First Name & Middle Initial & Last Name or Official Title & Degree

Regulatory Specialist

Phone

937-245-7500

pturesearch@wrightstatephysicians.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey B Travers, MD, PhD

Organizational Affiliation

Wright State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wright State Physicians

City

Fairborn

State/Province

Ohio

ZIP/Postal Code

45324

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manager, Clinical Research Operations

Phone

937-245-7500

pturesearch@wrightstatephysicians.org

First Name & Middle Initial & Last Name & Degree

Regulatory Specialist

Phone

937-245-7500

pturesearch@wrightstatephysicians.org

12. IPD Sharing Statement

Learn more about this trial

Photodynamic Therapy-Induced Immune Modulation: Part III

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