Explore Cutting-Edge Opzelura Treatment for Prurigo Nodularis

Are you or someone you know affected by Prurigo Nodularis (PN), a chronic skin condition characterized by intensely itchy nodules that significantly impact daily life? Join our clinical trial in New York to advance research in treating PN and potentially find relief through innovative therapies.

This study evaluates the safety and pharmacokinetics of Opzelura cream in adults aged 18 to 64 with widespread PN lasting at least 3 months and a total estimated body surface area (BSA) involvement of at least 25% (excluding scalp), along with a PN-related Worst Itch Numeric Rating Scale (WI-NRS) score of 7 or higher. Participate to receive expert care and monitoring while contributing to medical progress that could transform treatment options for PN.

New York location for dermatology study by Equity Medical
Study Location
New York
Office Address

200 Amsterdam Ave. New York, NY 10023

Office Phone
646-413-6020

Overview

Recruiting start date
  • 9/1/24
Duration
  • 16 Weeks
Population

Age 18–64 years with widespread PN ≥ 3 months and total estimated BSA ≥ 25% (excluding scalp) and PN-related WI-NRS itch score ≥ 7.

Study Drug

Opzelura Cream (100%, no placebo).

Study Design

This is a maximal use PN safety/PK study

Inclusion Criteria
  • Clinical diagnosis of PN ≥ 3 months before screening.
  • Pruriginous lesions (defined as papules, nodules, plaques, umbilicated lesions, and linear lesions) on ≥ 2 different body areas (such as right and left leg) at screening and baseline.
  • Total estimated treatment BSA ≥ 25% (excluding the scalp) at screening and baseline.
  • IGA-CPG-S score of ≥ 2 at screening and baseline.
  • Baseline PN-related WI-NRS score ≥ 7. Baseline WI-NRS score is defined as the 7-day average of WI-NRS scores before Day 1 (data from a minimum of 4 out of 7 days prior to Day 1 is needed).
Exclusion Criteria
  • Chronic or acute pruritus due to a condition other than PN.
  • Active AD lesions (signs and symptoms other than dry skin) within 6 months of screening and baseline.
  • Acute or chronic active HBV or HCV infection.
  • Any underlying condition known to be associated with the clinical presentation of PN that is not under control (stable) prior to the baseline visit.
  • Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator’s opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Compensation
  • Participants will receive $75 per visit
Studies
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