PhotosensitivityPhase 1NCT04520217
Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
A Phase 1 study testing 4% Imipramine Cream and Base Cream in people with Photosensitivity and Microvesicle Particle, run by Wright State University at 1 site in United States.
Trial summary
The purpose of this study is three-fold. First, researchers will assess whether subjects who have clinically abnormal reactions to sunlight (photosensitivity) have increased levels of microvesicle particles (MVP) following ultraviolet B (UVB) treatment to localized area of skin. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Photosensitivity, Microvesicle Particle
- What is being tested?
- 4% Imipramine Cream and Base Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 1 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female and Male adult subjects age 18 to 50
- Must be able to give informed consent
- Have access to stable transportation
- All skin types on Fitzpatrick Scale (Type I-VI)
- Self-Identified photosensitivity
- Able to provide medical history and list of medications-control subjects will not be allowed to be taking a medication that is known to be photosensitizer.
Who cannot join
- Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)
- Taking medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS [except for low-dose aspirin] or steroids)
- Utilizing imipramine or any other tricyclic antidepressant (oral or cream)
- Utilizing topical anti-inflammatory or systemic agents (e.g., prednisone)
- Large tattoos in the designated testing areas
- Tanning bed use within last 3 months
Show all 9Show fewer
- Photodynamic Therapy or UVB treatments in past 3 months
- Female Subjects: pregnant or nursing
- History of abnormal scarring (i.e., keloids)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wright State Physicians
Fairborn, Ohio, 45324
About this study
Official title: Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
The purpose of this study is three-fold. First, researchers will assess whether subjects who have clinically abnormal reactions to sunlight (photosensitivity) have increased levels of microvesicle particles (MVP) following ultraviolet B (UVB) treatment to localized area of skin. Second, researchers will assess if topical application of the medicine imipramine will block UVB-induced MVP release. Third, researchers will assess if the topical cream will block UVB-induced increased erythema reactions (reddening of the skin).
- Conditions
- Photosensitivity, Microvesicle Particle
- Being tested
- 4% Imipramine Cream, Base Cream
- Medical subject headings
- Photosensitivity Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% Imipramine CreamDrug
4% Imipramine Cream
Base CreamDrug
Base Cream
| Study group | Role | What they receive |
|---|---|---|
| 4% Imipramine Cream on UVB-Treated Areas | Experimental | * 2g of 4% imipramine cream will be applied to the UVB-treated areas on volar forearm and back.
* 2g of base cream will be applied to the UVB-treated areas on volar forearm and back.
* No cream will be applied to a UVB-treated area on the back Receives: Drug: 4% Imipramine Cream; 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 in clinically photosensitive subjects
This will be measured in skin biopsies obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.
Measured: 4 Hours
Change in microvesicle particle levels from baseline post topical imipramine application
This will be measured in skin biopsies with topical imipramine applied. Biopsies are obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.
Measured: 4 Hours
Change in skin erythema from baseline on topical imipramine treated skin
This will be measured with a mexameter at 4 hours.
Measured: 4 Hours
Change in skin erythema from baseline on topical imipramine treated skin
This will be measured with a mexameter at 24 hours.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start6 Jun 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotosensitivityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
- NCT04520217
- Sponsor's protocol ID
- 06919
- Status last verified
- Jan 2025
- First submitted
- 17 Aug 2020
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects
- ClinicalTrials.gov ID
- NCT04520217
- Acronym / sponsor ID
- 06919
- Conditions
- Photosensitivity, Microvesicle Particle
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Aug 2020 (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.
The purpose of this study is three-fold. First, researchers will assess whether subjects who have clinically abnormal reactions to sunlight (photosensitivity) have increased levels of microvesicle particles (MVP) following ultraviolet B (UVB) treatment to localized area of skin. Second, researchers will assess if topical application of the medicine imipramine will block UVB-induced MVP release. Third, researchers will assess if the topical cream will block UVB-induced increased erythema reactions (reddening of the skin).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4% Imipramine Cream on UVB-Treated Areas | Experimental | Drug: 4% Imipramine Cream, Drug: Base Cream* 2g of 4% imipramine cream will be applied to the UVB-treated areas on volar forearm and back. * 2g of base cream will be applied to the UVB-treated areas on volar forearm and back. * No cream will be applied to a UVB-treated area on the back |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female and Male adult subjects age 18 to 50
- Must be able to give informed consent
- Have access to stable transportation
- All skin types on Fitzpatrick Scale (Type I-VI)
- Self-Identified photosensitivity
Key exclusion criteria (9 listed)
- Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)
- Taking medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS [except for low-dose aspirin] or steroids)
- Utilizing imipramine or any other tricyclic antidepressant (oral or cream)
- Utilizing topical anti-inflammatory or systemic agents (e.g., prednisone)
- Large tattoos in the designated testing areas
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 |
|---|---|---|
| 4% Imipramine Cream4% Imipramine Cream | Drug | 4% Imipramine Cream on UVB-Treated Areas |
| Base CreamBase Cream | Drug | 4% Imipramine Cream on UVB-Treated Areas |
Primary outcome
Change in microvesicle particle levels from baseline in clinically photosensitive subjects
Time frame: 4 Hours
This will be measured in skin biopsies obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.
Change in microvesicle particle levels from baseline post topical imipramine application
Time frame: 4 Hours
This will be measured in skin biopsies with topical imipramine applied. Biopsies are obtained at 4 hours following ultraviolet B radiation fluence of 1000 J/m2.
Change in skin erythema from baseline on topical imipramine treated skin
Time frame: 4 Hours
This will be measured with a mexameter at 4 hours.
Change in skin erythema from baseline on topical imipramine treated skin
Time frame: 24 Hours
This will be measured with a mexameter at 24 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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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.
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 4% Imipramine Cream and Base Cream in people with Photosensitivity 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. 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?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manager Clinical Research Operations (937-245-7500, pturesearch@wrightstatephysicians.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microvesicle particle levels from baseline in clinically photosensitive subjects (time frame: 4 Hours). The study lists 4 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 27 Jan 2025.