Photodynamic TherapyEarly Phase 1NCT03960125
Photodynamic Therapy and Microvesicles
A Early Phase 1 study testing Photodynamic Therapy, 4% Imipramine and Base Cream in people with Photodynamic Therapy and Microvesicle Particle, run by Wright State University at 1 site in United States.
Trial summary
This study is designed to test whether localized photodynamic therapy (PDT) treatment will result in increased skin levels of microvesicle particle (MVP) and if the use of imipramine will counteract PDT generated MVP release. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Photodynamic Therapy, Microvesicle Particle
- What is being tested?
- Photodynamic Therapy, 4% Imipramine and Base Cream
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2021to Sep 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male adult subjects age 21 to age 45
- Skin type must be "fair", Fitzpatrick type I or II
- Able to understand/complete informed/consent
- Have access to stable transportation
Who cannot join
- Underlying diseases that could affect wound healing (e.g., diabetes mellitus)
- Taking medications that are known photosensitizers (e.g., doxycycline) or anti- inflammatories (e.g., NSAIDS [except for low-dose aspirin] or steroids)
- Have a history of abnormal scarring (e.g., keloids)
- Taking vitamin C or E supplements for past month
- Utilizing imipramine or any other tricyclic antidepressant (oral or cream)
- Utilizing topical anti-inflammatory or systemic agents (eg, prednisone)
- Tanning bed use within last 3 months
- PDT or UVB treatments in past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to test whether localized photodynamic therapy (PDT) treatment will result in increased skin levels of microvesicle particle (MVP) and if the use of imipramine will counteract PDT generated MVP release. The effects of PDT and ultraviolet B radiation (UVB) on platelet-activating factor (PAF) and MVP production have long been part of the PI's research experience. To test this, the investigator plans to enroll up to enroll up to 12 male subjects whom are aged 21 to age 45. These subjects will be treated with topical 5-aminolevulinic acid gel (Ameluz) to small areas of forearm followed by treatment with blue light. The areas will then be treated with either 4% imipramine cream or cream base as control. Four hours later, the redness of the areas will be measured using a mexameter and MVPs measured in skin biopsies taken from PDT-treated skin.
- Conditions
- Photodynamic Therapy, Microvesicle Particle
- Being tested
- Photodynamic Therapy, 4% Imipramine, Base Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic TherapyDevice
Blue Light Therapy Exposure
4% ImipramineDrug
A tricyclic antidepressant (TCA) medication. Though it is usually taken orally, topical preparations (4%) has use in topical anesthetics and anti-pain medicaments.
Base CreamDrug
Control to 4% Imipramine
| Study group | Role | What they receive |
|---|---|---|
| 4% Imipramine Cream on Upper Forearm Site | Experimental | Base cream will be applied to the lower forearm site. Receives: Device: Photodynamic Therapy; Drug: 4% Imipramine; Drug: Base Cream |
| 4% Imipramine Cream on Lower Forearm Site | Experimental | Base cream will be applied to the upper forearm site. Receives: Device: Photodynamic Therapy; Drug: 4% Imipramine; Drug: Base Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Microvesicle Particle Levels From Baseline with Photodynamic Therapy.
PI will assess change from baseline using three 5 mm punch biopsies.
Measured: Day 0
Change in Microvesicle Particle Levels From Baseline with 4% Imipramine Cream Treatment.
PI will assess change from baseline using three 5 mm punch biopsies.
Measured: Day 2
Secondary outcomes (3)
Change in Erythema From Baseline Due to Photodynamic Therapy
PI will assess change from baseline by using a non-invasive mexameter.
Measured: Day 2
Change in Skin Pain From Baseline Due to Photodynamic Therapy
PI will assess change with the Skin Pain Visual Analogue Scale. Participants indicate the overall severity of skin pain from the photodynamic therapy treatment at the present time by placing a single mark on the horizontal scale (0 = no skin pain to 10 = severe skin pain)
Measured: Day 2
Change in Itch From Baseline Due to Photodynamic Therapy
PI will assess change with the Itch Numerical Scale. Participants will rate itching severity due to photodynamic therapy treatment by circling the number that best describes the worst level of itching in the past 24 hours. (0 = No itch to 10 = Worst itch imaginable)
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start29 Mar 2021
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: The PI decided to move in another direction with his research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodynamic TherapyStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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 Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960125
- Sponsor's protocol ID
- 06714
- Status last verified
- Sep 2022
- First submitted
- 20 May 2019
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy and Microvesicles
- ClinicalTrials.gov ID
- NCT03960125
- Acronym / sponsor ID
- 06714
- Conditions
- Photodynamic Therapy, Microvesicle Particle
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI decided to move in another direction with his research.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
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 to test whether localized photodynamic therapy (PDT) treatment will result in increased skin levels of microvesicle particle (MVP) and if the use of imipramine will counteract PDT generated MVP release. The effects of PDT and ultraviolet B radiation (UVB) on platelet-activating factor (PAF) and MVP production have long been part of the PI's research experience. To test this, the investigator plans to enroll up to enroll up to 12 male subjects whom are aged 21 to age 45. These subjects will be treated with topical 5-aminolevulinic acid gel (Ameluz) to small areas of forearm followed by treatment with blue light. The areas will then be treated with either 4% imipramine cream or cream base as control. Four hours later, the redness of the areas will be measured using a mexameter and MVPs measured in skin biopsies taken from PDT-treated skin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4% Imipramine Cream on Upper Forearm Site | Experimental | Device: Photodynamic Therapy, Drug: 4% Imipramine, Drug: Base CreamBase cream will be applied to the lower forearm site. |
| 4% Imipramine Cream on Lower Forearm Site | Experimental | Device: Photodynamic Therapy, Drug: 4% Imipramine, Drug: Base CreamBase cream will be applied to the upper forearm site. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male adult subjects age 21 to age 45
- Skin type must be "fair", Fitzpatrick type I or II
- Able to understand/complete informed/consent
- Have access to stable transportation
Key exclusion criteria (8 listed)
- Underlying diseases that could affect wound healing (e.g., diabetes mellitus)
- Taking medications that are known photosensitizers (e.g., doxycycline) or anti- inflammatories (e.g., NSAIDS [except for low-dose aspirin] or steroids)
- Have a history of abnormal scarring (e.g., keloids)
- Taking vitamin C or E supplements for past month
- Utilizing imipramine or any other tricyclic antidepressant (oral or cream)
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 |
|---|---|---|
| Photodynamic TherapyBlue Light Therapy Exposure | Device | 4% Imipramine Cream on Lower Forearm Site, 4% Imipramine Cream on Upper Forearm Site |
| 4% ImipramineA tricyclic antidepressant (TCA) medication. Though it is usually taken orally, topical preparations (4%) has use in topical anesthetics and anti-pain medicaments. | Drug | 4% Imipramine Cream on Lower Forearm Site, 4% Imipramine Cream on Upper Forearm Site |
| Base CreamControl to 4% Imipramine | Drug | 4% Imipramine Cream on Lower Forearm Site, 4% Imipramine Cream on Upper Forearm Site |
Primary outcome
Change in Microvesicle Particle Levels From Baseline with Photodynamic Therapy.
Time frame: Day 0
PI will assess change from baseline using three 5 mm punch biopsies.
Change in Microvesicle Particle Levels From Baseline with 4% Imipramine Cream Treatment.
Time frame: Day 2
PI will assess change from baseline using three 5 mm punch biopsies.
3 secondary outcomes
Change in Erythema From Baseline Due to Photodynamic Therapy
Time frame: Day 2
Change in Skin Pain From Baseline Due to Photodynamic Therapy
Time frame: Day 2
Change in Itch From Baseline Due to Photodynamic Therapy
Time frame: Day 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
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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 Physicians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Photodynamic Therapy, 4% Imipramine and Base Cream in people with Photodynamic Therapy and Microvesicle Particle, 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 13 Sep 2022. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Microvesicle Particle Levels From Baseline with Photodynamic Therapy. (time frame: Day 0). The study lists 2 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 13 Sep 2022.