Photodynamic Therapy-Induced Immune Modulation: Part III

Phase 1

Terminated

• Conditions: Actinic Keratosis; Photodynamic Therapy
• Interventions: Drug: Celecoxib 200mg; Drug: Placebo

• Registration Number: NCT03643744
• Lead Sponsor: Wright State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-23
• Study Start: 2019-04-01
• Primary Completion: 2023-03-21
• Study Completion: 2023-03-21
• Results First Submitted: 2024-01-22
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Results First Posted: 2024-12-19
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDT + Celecoxib	Celecoxib 200mg	Patient receiving PDT taking 200mg celecoxib.
Control + Celecoxib	Celecoxib 200mg	Control subject not receiving PDT taking 200mg celecoxib.
PDT + Placebo	Placebo	Patient receiving PDT taking placebo.
Control + Placebo	Placebo	Control subject not receiving PDT taking placebo.

Primary Outcome Measures

Name	Time	Method
Changes in Photodynamic Therapy (PDT)-Induced Systemic Immunosuppression From Baseline With Celecoxib Treatment.	Baseline and Day 7	Investigator measures areas of inflammation from the reactions to intradermal (candida and trichophyton antigens) skin testing to calculate the areas of reaction. The areas of induration were measured using calipers with cm2 as the unit of measurement. The outcome measurement was calculated by using the cm2 measurements from baseline and Day 7 to calculate the percentage of initial reaction area.
Change From Baseline in the Number of Actinic Keratosis at 6 Months.	6 Months after PDT treatment at Day 0	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.	12 Months after PDT treatment at Day 0	Investigator will assess the number of actinic keratosis in the PDT-treated areas.

Trial Locations

Locations (1)

Wright State Physicians; 🇺🇸 Fairborn, Ohio, United States