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Celecoxib for Actinic Keratosis
Phase 1
Waitlist Available
Led By Jeffrey B Travers, MD, PhD
Research Sponsored by Jeffrey B. Travers, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is designed to study whether the immunosuppression caused by PDT can be mitigated by treatment with celecoxib, compared to placebo. Subjects will be monitored for 6 and 12 months after the study.
Eligible Conditions
- Actinic Keratosis
- Photodynamic Therapy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in the Number of Actinic Keratosis at 12 months.
Change From Baseline in the Number of Actinic Keratosis at 6 months.
Changes in Photodynamic Therapy (PDT)-induced Systemic Immunosuppression From Baseline with Celecoxib Treatment.
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: PDT + CelecoxibActive Control1 Intervention
Patient receiving PDT taking 200mg celecoxib.
Group II: Control + CelecoxibActive Control1 Intervention
Control subject not receiving PDT taking 200mg celecoxib.
Group III: Control + PlaceboPlacebo Group1 Intervention
Control subject not receiving PDT taking placebo.
Group IV: PDT + PlaceboPlacebo Group1 Intervention
Patient receiving PDT taking placebo.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Jeffrey B. Travers, MD, PhDLead Sponsor
4 Previous Clinical Trials
144 Total Patients Enrolled
Wright State UniversityLead Sponsor
41 Previous Clinical Trials
54,870 Total Patients Enrolled
Jeffrey B Travers, MD, PhDPrincipal InvestigatorWright State University
9 Previous Clinical Trials
248 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 45 years old or older.You can understand and follow the study instructions.You need to be at least 45 years old.You have fair skin that is typically seen in Caucasians with Fitzpatrick skin types I and II.You have a reliable way to get to and from the study location.A dermatologist from Wright State University has recommended PDT treatment for actinic damage, specifically actinic keratoses that require treatment with the BLU-U.You have recently had photodynamic therapy (PDT) on a large area of your body, such as your face, scalp, arms, chest or back.You are able to understand the information provided in the study and follow the instructions given, and you have a reliable means of transportation.
Research Study Groups:
This trial has the following groups:- Group 1: PDT + Celecoxib
- Group 2: Control + Placebo
- Group 3: PDT + Placebo
- Group 4: Control + Celecoxib
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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