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Trial Outcomes & Findings for Photodynamic Therapy-Induced Immune Modulation: Part III (NCT NCT03643744)

NCT ID: NCT03643744

Last Updated: 2024-12-19

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Baseline and Day 7

Results posted on

2024-12-19

Participant Flow

Subjects were recruited from the Dayton, OH area. Patients who were prescribed to undergo photodynamic therapy (PDT) for actinic keratoses at Wright State Physicians were recruited. The control (patients who did not need photodynamic therapy) subjects where also recruited from Wright State Physicians or from the community.

Participant milestones

Participant milestones
Measure
PDT + Celecoxib
Patient receiving PDT taking 200mg celecoxib. Celecoxib 200mg: 14 Celecoxib 200mg taken total over 7 days (1 is taken in the morning and 1 is taken in the evening).
PDT + Placebo
Patient receiving PDT taking placebo. Placebo: 14 placebo capsules taken total over 7 days (1 is taken in the morning and 1 is taken in the evening).
Control + Celecoxib
Control subject not receiving PDT taking 200mg celecoxib. Celecoxib 200mg: 14 Celecoxib 200mg taken total over 7 days (1 is taken in the morning and 1 is taken in the evening).
Control + Placebo
Control subject not receiving PDT taking placebo. Placebo: 14 placebo capsules taken total over 7 days (1 is taken in the morning and 1 is taken in the evening).
Overall Study
STARTED
3
3
3
3
Overall Study
COMPLETED
3
3
3
3
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Photodynamic Therapy-Induced Immune Modulation: Part III

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PDT + Celecoxib
n=3 Participants
Patient receiving PDT taking 200mg celecoxib. Celecoxib 200mg: 14 Celecoxib 200mg taken total over 7 days (1 is taken in the morning and 1 is taken in the evening).
PDT + Placebo
n=3 Participants
Patient receiving PDT taking placebo. Placebo: 14 placebo capsules taken total over 7 days (1 is taken in the morning and 1 is taken in the evening).
Control + Celecoxib
n=3 Participants
Control subject not receiving PDT taking 200mg celecoxib. Celecoxib 200mg: 14 Celecoxib 200mg taken total over 7 days (1 is taken in the morning and 1 is taken in the evening).
Control + Placebo
n=3 Participants
Control subject not receiving PDT taking placebo. Placebo: 14 placebo capsules taken total over 7 days (1 is taken in the morning and 1 is taken in the evening).
Total
n=12 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
4 Participants
n=21 Participants
Age, Categorical
>=65 years
3 Participants
n=5 Participants
3 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
8 Participants
n=21 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
4 Participants
n=21 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
8 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
3 Participants
n=4 Participants
12 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
3 Participants
n=4 Participants
12 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
PDT + Celecoxib
n=3 Participants
Patient receiving PDT taking 200mg celecoxib. Celecoxib 200mg: 14 Celecoxib 200mg taken total over 7 days (1 is taken in the morning and 1 is taken in the evening).
PDT + Placebo
n=3 Participants
Patient receiving PDT taking placebo. Placebo: 14 placebo capsules taken total over 7 days (1 is taken in the morning and 1 is taken in the evening).
Control + Celecoxib
n=3 Participants
Control subject not receiving PDT taking 200mg celecoxib. Celecoxib 200mg: 14 Celecoxib 200mg taken total over 7 days (1 is taken in the morning and 1 is taken in the evening).
Control + Placebo
n=3 Participants
Control subject not receiving PDT taking placebo. Placebo: 14 placebo capsules taken total over 7 days (1 is taken in the morning and 1 is taken in the evening).
Changes in Photodynamic Therapy (PDT)-Induced Systemic Immunosuppression From Baseline With Celecoxib Treatment.
152 Percentage of initial reaction area
Standard Error 107
78 Percentage of initial reaction area
Standard Error 19
206 Percentage of initial reaction area
Standard Error 58
170 Percentage of initial reaction area
Standard Error 44

PRIMARY outcome

Timeframe: 6 Months after PDT treatment at Day 0

Population: Study was terminated before this outcome measurement time frame occurred, therefore data was not collected for this outcome.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 Months after PDT treatment at Day 0

Population: Study was terminated before this outcome measurement time frame occurred, therefore data was not collected for this outcome.

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

Outcome measures

Outcome data not reported

Adverse Events

PDT + Celecoxib

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

PDT + Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control + Celecoxib

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control + Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey Travers

Wright State University

Phone: (937)-245-7500

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place