← Back to Search

The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain

Phase 2
Waitlist Available
Led By R James White, MD, PhD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minute period of patch application and subsequent 3 days
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial hypertension, a life threatening disease of the lung blood vessels. Unfortunately, treprostinil is irritating to the skin and many patients experience intense pain at the infusion site for the first 7-10 days after placing a new subcutaneous infusion site. Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that pretreatment of an area of skin with Qutenza would decrease the pain associated with a new treprostinil infusion site. The investigators hope that Qutenza will decrease both the intensity of the pain and the duration of the pain after patients place a new treprostinil infusion site. In this initial study, the investigators will provide Qutenza in open-label, unblinded fashion and ask patients to rate their pain using a diary tool with which they are already comfortable.

Eligible Conditions
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minute period of patch application and subsequent 3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minute period of patch application and subsequent 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain Score on a Visual Analogue Scale
Secondary study objectives
Pain
Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change

Side effects data

From 2012 Phase 2 trial • 6 Patients • NCT01260454
50%
pain at the application site
17%
hypertension
17%
headache
17%
nasal congestion
17%
sore throat
100%
80%
60%
40%
20%
0%
Study treatment Arm
Qutenza Patch

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Qutenza patchExperimental Treatment1 Intervention
All participants actively treated with Qutenza
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capsaicin
FDA approved

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
872 Previous Clinical Trials
550,091 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
50 Patients Enrolled for Pulmonary Arterial Hypertension
United TherapeuticsIndustry Sponsor
110 Previous Clinical Trials
14,520 Total Patients Enrolled
59 Trials studying Pulmonary Arterial Hypertension
8,279 Patients Enrolled for Pulmonary Arterial Hypertension
R James White, MD, PhDPrincipal InvestigatorUniversity of Rochester
~0 spots leftby Jan 2026