---
title: Photodynamic Therapy and Microvesicles
nct_id: NCT03960125
overall_status: WITHDRAWN
phase: EARLY_PHASE1
sponsor: Wright State University
study_type: INTERVENTIONAL
primary_condition: Photodynamic Therapy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03960125.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03960125"
ct_last_update_post_date: 2022-09-13
last_seen_at: "2026-05-12T06:48:44.114Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Photodynamic Therapy and Microvesicles

**NCT ID:** [NCT03960125](https://clinicaltrials.gov/study/NCT03960125)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** The PI decided to move in another direction with his research.
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Wright State University
- **Conditions:** Photodynamic Therapy, Microvesicle Particle
- **Start Date:** 2021-03-29
- **Completion Date:** 2022-09
- **CT.gov Last Update:** 2022-09-13

## Brief 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. 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.

## Eligibility

- **Minimum age:** 21 Years
- **Maximum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
```

## Arms

- **4% Imipramine Cream on Upper Forearm Site** (EXPERIMENTAL) — Base cream will be applied to the lower forearm site.
- **4% Imipramine Cream on Lower Forearm Site** (EXPERIMENTAL) — Base cream will be applied to the upper forearm site.

## Interventions

- **Photodynamic Therapy** (DEVICE) — Blue Light Therapy Exposure
- **4% Imipramine** (DRUG) — A tricyclic antidepressant (TCA) medication. Though it is usually taken orally, topical preparations (4%) has use in topical anesthetics and anti-pain medicaments.
- **Base Cream** (DRUG) — Control to 4% Imipramine

## Primary Outcomes

- **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.

## 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)_

## Locations (1)

- Wright State Physicians, Fairborn, Ohio, United States

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.wright state physicians|fairborn|ohio|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03960125.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03960125*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*