Actively Recruiting
Pilot Studies Testing the Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
Led by Wright State University · Updated on 2024-04-24
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the combined use of topical Imipramine and topical photodynamic therapy (PDT) to see if this combination affects pain after treatment. PDT is a common dermatology treatment for people with many precancerous skin lesions called actinic keratosis (AK). Both Imipramine and PDT are FDA-approved treatments, but their combined use has not been evaluated before. Animal studies suggest Imipramine might reduce pain from PDT and improve its effectiveness. Participants will receive either topical 4% Imipramine or a placebo vehicle before PDT treatment. The study is randomized and double-blinded, meaning participants are randomly assigned to one of the two treatment groups without knowing which they receive. The treatments will be applied to areas such as the face, scalp, or forearms where PDT is needed. During the study, participants will be monitored for pain and itch levels immediately after PDT treatment, at 10 minutes, 30 minutes, and again at 6 months post-treatment. The main measure is the number of precancerous AK lesions remaining six months after PDT. The study will track safety and treatment effects over this time, ensuring participants understand the process and follow sun exposure precautions. The total study duration extends up to six months post-treatment.
CONDITIONS
Brief Title
The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Fair skin type, Fitzpatrick type I to III
- Physician's order for photodynamic therapy on face, scalp, or forearms
- Willing to participate and understand informed consent
- Willing to avoid excess sun exposure or tanning beds on treatment areas
You will not qualify if you...
- Currently taking any tricyclic antidepressants (TCAs)
- Currently taking any selective serotonin reuptake inhibitors (SSRIs)
- Having porphyria
- Large tattoos in the treatment areas
- Pregnant or nursing
- Taking medications that may interfere with photodynamic therapy
- Having active rashes in the treatment area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment day with immediate and short-term assessments up to 30 minutes post treatment
Participants receive topical photodynamic therapy along with either topical 4% Imipramine or vehicle to evaluate pain and effectiveness.
1 treatment visit with assessments immediately, 10 minutes, and 30 minutes after treatment
Duration - 6 months post treatment
Participants are followed for up to 6 months after treatment to assess long-term effects on precancerous lesions and symptoms.
Periodic follow-up visits over 6 months
Trial Site Locations
Total: 1 location
1
Wright State Physicians
Fairborn, Ohio, United States, 45324
Actively Recruiting
Research Team
M
Manager, Clinical Research Operations
R
Regulatory Specialist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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