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Photodynamic Therapy-Induced Immune Modulation: Part III

NCT ID: NCT03643744

Last Updated: 2024-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2023-03-21

Brief Summary

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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.

Detailed Description

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Conditions

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Actinic Keratosis Photodynamic Therapy

Keywords

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Actinic Keratosis Photodynamic Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PDT + Celecoxib

Patient receiving PDT taking 200mg celecoxib.

Group Type ACTIVE_COMPARATOR

Celecoxib 200mg

Intervention Type DRUG

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

PDT + Placebo

Patient receiving PDT taking placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Control + Celecoxib

Control subject not receiving PDT taking 200mg celecoxib.

Group Type ACTIVE_COMPARATOR

Celecoxib 200mg

Intervention Type DRUG

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

Control + Placebo

Control subject not receiving PDT taking placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Celecoxib 200mg

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* 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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wright State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey B Travers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wright State University

Locations

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Wright State Physicians

Fairborn, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Research Subjects

View Document

Document Type: Informed Consent Form: Control Subjects

View Document

Other Identifiers

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06499

Identifier Type: -

Identifier Source: org_study_id