Photodynamic Therapy-Induced Immune Modulation: Part III

NCT03643744 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 06499
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratosis; Photodynamic Therapy

Keywords

Actinic Keratosis; Photodynamic Therapy

Outcome Measures

Primary Outcomes (3)

• Changes in Photodynamic Therapy (PDT)-Induced Systemic Immunosuppression From Baseline With Celecoxib Treatment.

  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.

  Baseline and Day 7

• 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 after PDT treatment at Day 0

• 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 after PDT treatment at Day 0

Study Arms (4)

PDT + Celecoxib

ACTIVE COMPARATOR

Patient receiving PDT taking 200mg celecoxib.

Drug: Celecoxib 200mg

PDT + Placebo

PLACEBO COMPARATOR

Patient receiving PDT taking placebo.

Drug: Placebo

Control + Celecoxib

ACTIVE COMPARATOR

Control subject not receiving PDT taking 200mg celecoxib.

Drug: Celecoxib 200mg

Control + Placebo

PLACEBO COMPARATOR

Control subject not receiving PDT taking placebo.

Drug: Placebo

Interventions

Celecoxib 200mg DRUG

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

Control + Celecoxib; PDT + Celecoxib

Placebo DRUG

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

Control + Placebo; PDT + Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jeffrey Travers
• Organization: Wright State University

Jeffrey.Travers@Wright.edu

(937)-245-7500

Study Officials

• Jeffrey B Travers, MD, PhD

  Wright State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 23, 2018
• Study Start: April 1, 2019
• Primary Completion: March 21, 2023
• Study Completion: March 21, 2023
• Last Updated: December 19, 2024
• Results First Posted: December 19, 2024

Record last verified: 2024-12

Locations

US (1)