Actinic KeratosisPhase 1NCT03643744
Photodynamic Therapy-Induced Immune Modulation: Part III
A Phase 1 study testing Celecoxib 200mg in people with Actinic Keratosis and Photodynamic Therapy, run by Wright State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratosis, Photodynamic Therapy
- What is being tested?
- Celecoxib 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 21 Mar 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Celecoxib 200mg, Placebo
- Keywords
- Actinic Keratosis, Photodynamic Therapy
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celecoxib 200mgDrug
14 Celecoxib 200mg taken 1 in the morning and 1 in the evening.
PlaceboDrug
14 placebo capsules taken 1 in the morning and 1 in the evening.
| Study group | Role | What they receive |
|---|---|---|
| PDT + Celecoxib | Active comparator | Patient receiving PDT taking 200mg celecoxib. Receives: Drug: Celecoxib 200mg |
| PDT + Placebo | Placebo comparator | Patient receiving PDT taking placebo. Receives: Drug: Placebo |
| Control + Celecoxib | Active comparator | Control subject not receiving PDT taking 200mg celecoxib. Receives: Drug: Celecoxib 200mg |
| Control + Placebo | Placebo comparator | Control subject not receiving PDT taking placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 Months after PDT treatment at Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start1 Apr 2019
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
Why it stopped: Per PI due to data analysis results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey B Travers, MD, PhD, Principal investigator, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643744
- Sponsor's protocol ID
- 06499
- Status last verified
- Dec 2024
- First submitted
- 14 Aug 2018
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy-Induced Immune Modulation: Part III
- ClinicalTrials.gov ID
- NCT03643744
- Acronym / sponsor ID
- 06499
- Conditions
- Actinic Keratosis, Photodynamic Therapy
- Keywords
- Actinic Keratosis, Photodynamic Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per PI due to data analysis results.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Posted 19 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PDT + Celecoxib | Active comparator | Drug: Celecoxib 200mgPatient receiving PDT taking 200mg celecoxib. |
| PDT + Placebo | Placebo comparator | Drug: PlaceboPatient receiving PDT taking placebo. |
| Control + Celecoxib | Active comparator | Drug: Celecoxib 200mgControl subject not receiving PDT taking 200mg celecoxib. |
| Control + Placebo | Placebo comparator | Drug: PlaceboControl subject not receiving PDT taking placebo. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib 200mg14 Celecoxib 200mg taken 1 in the morning and 1 in the evening. | Drug | Control + Celecoxib, PDT + Celecoxib |
| Placebo14 placebo capsules taken 1 in the morning and 1 in the evening. | Drug | Control + Placebo, PDT + Placebo |
Primary outcome
Changes in Photodynamic Therapy (PDT)-Induced Systemic Immunosuppression From Baseline With Celecoxib Treatment.
Time frame: 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.
Time frame: 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.
Time frame: 12 Months after PDT treatment at Day 0
Investigator will assess the number of actinic keratosis in the PDT-treated areas.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey B Travers, MD, PhD principal investigator
Wright State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Celecoxib 200mg in people with Actinic Keratosis and Photodynamic Therapy, run by Wright State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Photodynamic Therapy (PDT)-Induced Systemic Immunosuppression From Baseline With Celecoxib Treatment. (time frame: Baseline and Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.